There are three portal user types:
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User Type |
Rights |
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Administrator |
Manage user accounts and set up host groups at or below the Administrator's assigned group. An Administrator can create both End User and Administrator accounts, but only within the Administrator's home group. In an MSP (Managed Services Provider) environment, each client has Administrator accounts that have access only to the client's domain and only the host groups within that domain. Portal upgrades will automatically enable privileges for newly added reports and the display of the view including all objects, for all Administrators. Refer to the release notes for the list of reports and features introduced in a specific product release. |
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Super User |
A Super User's privileges cannot be revised by any other user. Everything an Administrator can do in addition to the following:
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End User |
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To create a user account
When you create a user account, you add user details and a password. Users can modify their passwords and some of their profile information, however, they cannot modify their access privileges. Access privileges and group membership is setup through a separate operation.
Preferences for locale, number and date formatting are set by the user using the user account menu.
See Manage your profile and set a language preference.
Required fields are denoted with an asterisk. and fields are limited to 64 characters.
The ID should be in an email format, as required by LDAP. This field is limited to 128 characters.
From the selector, select the User Type. For a definition of the privileges associated with a user type,
See About user types.
Select a Home Host group. A home host group is a host group to which a user belongs. This limits a user's access to data. A user can access any host groups that are lower in the hierarchy from the home host group.
The click-per-payment model, DiResta says, may also change influencers’ behavior—creating the “incentive to produce and amplify content in the most inflammatory way possible in order to drive the audience to take an action.” But at the most fundamental level, researchers voiced a concern about the potential for deception in civic discourse. DiResta said, “I don’t think the public really understands the extent to which the people making these posts are, in fact, potentially becoming enriched personally by them.”
The ramifications of not disclosing these ties can touch anyone, from your credulous grandmother all the way up to 1600 Pennsylvania Avenue. A knowledgeable person with insight into an Urban Legend campaign described one client’s effort to apply pressure on the FCC. According to the person, one of the influencers enlisted was Eric Bolling, a disgraced former Fox News host and one of just 51 people President Trump followed on Twitter. Bolling’s post involved a “telecoms issue,” with a goal “to apply as much pressure” as possible on the FCC. There were “thousands of engagements overnight” from Bolling’s tweet, the person said, which “the FCC commissioner, Ajit Pai, and the president followed and saw.”
Today, Bolling’s tweet does not appear to be on his feed. Most social media marketing campaigns get deleted when they’ve run their course, and I found Urban Legend’s campaigns to be no exception. Rinat said influencers always know the identity of a client—and followers will know, too, because the link generally takes them to a campaign page, where the sponsor can be identified. Later, he said transparency is “a very important thing to influencer marketing, and particularly for our model. Without it, audience trust drops, and the resulting engagement drops.” He also called for clearer rules from enforcement agencies.
While lionizing transparency, Urban Legend continues to shield the identities of its influencers and the clients who pay them. The company’s tactfully hands-off approach to disclosure, Farid said, makes the Exchange “a system that is—by design—ripe for abuse.”
“At best, the appearance is bad,” he continued. “At worst, it’s hiding something nefarious.”
ILLUSTRATION: MARIA FRADE
The satirist and critic H. L. Mencken once wrote that “whenever you hear a man speak of his love for his country, it is a sign that he expects to be paid for it.” The bone-dry notion that Americans would happily sell anything—even their patriotism—must have seemed like an amusing hypothetical at the time. But perhaps Mencken simply didn’t live long enough to see Americans offered the chance.
Last September, HuffPost reporter Jesselyn Cook noted a wave of Instagram posts that seemed to correspond with the timing of a large payment to Urban Legend for “advertising,” according to FEC filings, through a partner firm called Legendary Campaigns. The purchase was made by the National Republican Senatorial Committee, which fundraises for Senate campaigns. The posts had headlines like “End to Mask Mandates, Endless Lockdowns and Vaccine Passports!” and demanded “a full investigation into Biden-tech collusion.” Each post linked to NRSC petitions, which harvested names and emails.
When I asked Rinat about the posts, he initially said he didn’t think the campaigns came from Urban Legend. A few weeks later, however, an Urban Legend client shared with WIRED several backdated screenshots of their influencers’ posts. Each of these posts redirected users to a petition by using a highly unusual URL construction, which began “exc.to.” According to computer science researchers who examined the string, the top-level domain “.to” is registered to the country of Tonga and has a registration history that cannot be seen. The domain “exc” was registered with the URL-shortening service Bit.ly, which works with private business clients to turn their registered domains into redirect links (such as “es.pn” for the sports network). Since Urban Legend’s founding in 2020, “exc.to” could not be found elsewhere on the internet, except in one place: the HuffPost story, in which a 16-year-old’s Instagram post for the NRSC bore the telltale URL “END MASK MANDATES: exc.to/3zLvUFB.”
Shortly after San Francisco renters celebrated a law that expands tenants’ rights, one of the city’s biggest landlords fired back, notifying its residents that they can be evicted for attempting to organize.
At the end of June, GreenTree Property Management, a subsidiary of corporate landlord Veritas Investments, emailed its residents nine pages of “Updated House Rules” and noted that violating any of them may result in an eviction. The rules prohibit multiple actions vital to organizing, including distribution of “literature” in common areas, the hanging of signs or posters on any doors or windows, and “soliciting” more than four times a year.
The document explicitly states Veritas’ new rules are a response to a new tenants’ law.
Strict new dictums with harsh consequences have disturbed and concerned residents who’ve lived in Veritas properties for years, and signed far less restrictive agreements. W. Blake Gray, a tenant of a building recently acquired by GreenTree and a journalist, found new noise restrictions especially egregious. The rule allows someone to be evicted based on a single “boisterous party,” which is determined by management’s “sole discretion.”
“You are essentially giving the largest landlord in San Francisco the power to evict based on the say-so of the resident manager,” Gray said. “I don’t want to live next to someone who has loud parties, but there has to be a warning process.”
Gray replied to his property manager’s email and said he believed the rules to be illegal. “They wrote the most horrible set of rules and rights they could think of,” he said.
Though only a court could decide on the legality of the rules, many of the rules do appear legal according to a tenants lawyer. But some are more shaky. For example, the solicitation limit appears to adhere to San Francisco Administrative Code Chapter 49A.2, subsection b, which states “the landlord may establish other reasonable requirements … of such literature distribution, including a limitation of distribution.” An earlier version of that section had limited organizing to four times a year, but that had been explicitly removed in the new tenants’ law passed this year, making it unclear if a limit would be legal.
Still, “only a court would be able to make a determination on [legal] reasonableness” for specific cases, said Christina Varner, the executive director of the San Francisco Rent Board, the city’s Rent Ordinance oversight body.
To Veritas consultant Daniel Baldocchi, it’s clear the company is acting within its rights. “It’s more establishing rules around the organizing so it’s … reasonable,” Baldocchi said. He added that much of the language was borrowed directly from San Francisco Apartment Association housing guidance.
On the other hand, the rule about posting signs on doors appears to be illegal, said tenant attorney Joseph Tobener, who said this is the first time he has seen a rule restricting organizing in his 20 years of practice. He said a landlord cannot prohibit the posting of political signs.
“In my experience, GreenTree often pushes to the edge of what is legally allowed, and frequently crosses the line,” Tobener said.“These house rules are yet another example of this.”
The GreenTree document that these updated rules supersede any rules in tenants’ prior leases: “Failure to comply… may constitute a just cause for eviction.” This jolted the scores of GreenTree residents who received the email.
Existing tenants, however, cannot be evicted for violating these “updated house rules” unless they sign a document accepting the new lease terms, according to Section 12.20 of the Rent Board Rules and Regulations. Nowhere is that protection noted on the updated rules document sent to GreenTree tenants, which some residents complained was only available in English.
Debbie Nunez, a Veritas renter and member of the Veritas Tenants Association, feared that non-English-speaking tenants might misunderstand and readily accept the terms. “They are really masters of semantics, when they say ‘updates.’ [The new rules] contain things that could or would materially change an individual’s lease agreement,” she said. “Excuse my French — I call bullshit.”
If the rules are included in new tenants’ leases, they could possibly be legally evicted for violating the rules over a breach of lease, said Varner. These rules would make new leases much more restrictive than the original ones signed by longstanding tenants like Nunez and Gray.
Both of these tenants have no doubt that the rules were written explicitly to dilute organizing efforts and, as Nunez put it, to “interfere with the newly granted [tenants’] rights.”
And she is right that GreenTree’s Updated House Rules stipulate that it is a direct response to a recently passed city law that grants tenants the ability to “unionize” — a law that residents in 20 Veritas San Francisco buildings have attempted to use.
“Some of the changes you will find in this update to the House Rules are in response to new legislation,” begins the Updated House Rules document sent to residents. “This legislation grants tenant associations greater ability to organize and to confer with their building’s management team … ”
Although the updated rules intended to respond to increased tenant power, it seems to have stoked it. Nunez said she thinks other residents will “stand up” once they realize what Veritas is doing.
Gray hasn’t joined a tenants group, “but this made me want to do it … Maybe we want the power to stand up to a big corporation like Veritas.”
This article was corrected on July 7 to reference and link to the updated administration code. An earlier version referred to an outdated version.
Read this in The Manila Times digital edition.
EVERY so often, when I get invited to speak on leadership, the question on whether leaders are born, or made comes up. We know that the nature (genetics) versus nurture (environmental factors) on exceptional leaders have been debated for years.
The Scottish historian and philosopher, Thomas Carlyle, speaking on heroism in the 1840s, suggests that leadership traits are intrinsic, that a great leader is born possessing certain traits and attributes, and that such traits will emerge when needed, enabling them to lead. The great man theory explains history as the impact of great men or heroes, and that, "Universal History, the history of what man has accomplished in this world, is at bottom the History of the Great Men who have worked here."
In contrast, behavioral leadership theory points to leaders being created based on observing how leaders behave, and how these traits can be emulated by others. Organizations invest time and resources to train emerging leaders. The training industry estimates that leadership training is a $357.7 billion global industry (2020), excluding the expenditures of individuals for training programs, or revenues of educational institutions. We can deduce that leadership skills can be learned, and which is why there are so many leadership books in print. A cursory check says 15,000 titles are in print based on a 2013 survey, not counting published articles, and over 57,000 leadership titles in Amazon.
But perhaps it's worth reminding ourselves what makes outstanding leaders. There are many ways to lead, and you just have to find your brand of leadership.
The new paradigm
One of my favorite leadership authors, Bill George, who wrote Discover Your True North: Authentic Leadership, speaks of authentic leaders who are "driven by a moral and ethical purpose and never lose sight of their core values and principles. They lead with their hearts, cultivate long-term relationships and demonstrate excellence through self-discipline." He adds that nowadays you can no longer lead as "power-driven, top-down leadership, command and control." The new paradigm, he adds, is that of a "learn-it-all" kind of guy, instead of a "know-it-all" kind of leader.
Leaders inspire
A key trait is that leaders inspire. After all, you cannot lead if no one follows. My leadership professor, David Gergen, best known as an adviser to four American presidents, in his book Eyewitness to Power, describes the leadership gifts and deficiencies that led them to the White House. He notes that the best leaders inspire the troops — beyond the rhetoric, it's about the message. Citing US Supreme Court Justice Oliver Wendell Holmes Jr., he adds that every young person should participate in the passion of their generation, and "should look at service to the country," like "hearts touched with fire."
Faith and leadership
Leadership, in a capsule, is about faith — earning and keeping the faith of your followers. First, trust has to be earned; only then can they be steered towards a common vision. Personal integrity, according to Gergen, is the cornerstone; adding that, to believe in a leader also means that people must believe in the leader's competence and steadiness. Thus, the importance of character and capacity, the prerequisites to earning people's trust. To be a good leader, you need to earn the faith of people — they want great leaders to succeed. They want to have faith that if the leader succeeds, they too, will succeed.
The other side of the coin is humility. The ability to be without pride or arrogance. A leader that recognizes his or her equality with followers is truly inspiring. To borrow a phrase from the Bible, "When pride comes, then comes disgrace, but with humility comes wisdom." (Proverbs 11:12)
The dangers of leadership
"Do what is right, not what is easy," is the often-quoted line, because leadership is not easy, and can even be dangerous. "Leadership becomes dangerous," as Harvard professors Ronald Heifetz and Martin Linsky write, "when leaders question people's habits, values and beliefs and people cannot see the bright future leaders ask them to sacrifice for, but see only suggested possibilities requiring great loss."
Indeed, the difficult part is "... to actually exercise power when you get to the top — to actually get things done," according to Gergen. He opines that it's easy to become a leader, to get to the top, especially with the advent of social media. However, it is difficult to become a good leader, as there are "... so many barriers in the way of progress."
Leaders adapt
This is where adaptive leadership is needed. Heifetz, one of the world's foremost figures on the practice and teaching of leadership, says adaptive leadership is "the practice of mobilizing people to tackle tough challenges and thrive." These leaders are "open-minded, willing to self-correct and empathetic toward their employees," where adaptive leaders value every person's opinion, and that each team member has the ability to solve the challenges.
In conclusion, one final reminder. To quote Carl W. Buehne, "They may forget what you said — but they will never forget how you made them feel." And so, remember to convey your appreciation, thank them in public, praise their good work, and when possible, and with the help of social media — remember their birthdays.
The author completed her Master in Public Administration at the Harvard Kennedy School.
MANILA, Philippines — Following the launch of Project Gunita, a citizen-led online archive of Martial Law era materials, it seems as though the heavy task of memorializing a nation’s dark past is over for its 19-year-old project co-founder Karl Patrick Suyat.
But archiving is only the beginning, Suyat said.
The UP student urged the public to maximize their digitized repository of dozens of newspapers and books covering the 21-year dictatorship of Ferdinand Marcos Sr.
“It shouldn’t stop at archiving,” Suyat said. “It should extend to using the archive itself, kasi wala namang silbi ‘yung archives kung in-archive lang siya. So gamitin natin.”
When Marcos Sr.’s only son and namesake won the May 9 presidential elections by a wide margin, the first thing that crossed Suyat’s mind were the Martial Law archives.
As a son of an activist and grandson of a political detainee, Suyat made it his personal mission to preserve the memory of his family’s late patriarchs — both of whom exposed Suyat to the Martial Law atrocities at a young age of seven.
But Suyat knew he wasn’t the only one who feared an imminent banning of Martial Law-related materials. A few days after the elections, Suyat and his friend crowdsourced for funds online, generating over P100,000 to purchase physical copies of newspapers and books as well as a book scanner.
“People’s generosity and their affinity with the cause are the lifeblood of this project,” Suyat said.
The digital archive displays PDF copies of martial law-related books such as Raymond Bonners’ “Waltzing with a Dictator”, Primitivo Mijares’ “The Conjugal Dictatorship” and Danilo Vizmanos’ “Martial Law Diary.”
It also provides scanned copies of old newspapers and magazines from the Marcos dictatorship, including WE Forum, Ang Pahayagang Malaya, Veritas, and The People’s Voice.
Photo by Karl Patrick Suyat
Project Gunita’s collection were mostly sourced from Filipiniana booksellers or private citizens’ collections who donated their archival materials or sold them to the independent archiving team at a cheaper price.
“Andito sa atin ‘yung materyales. The only question is paano natin to miminahin isa-isa and how are we going to make content - memes, informative videos, explainers, articles. Every single thing we could make out of it,” he said.
Although younger Filipino generations mostly read their news from social media nowadays, Suyat hopes to renew the public’s interest in the mosquito press – or the alternative media that were critical of the elder Marcos’ administration.
Likened to mosquitoes, the publications were known to have a “small but stinging bite” amid the heavily-controlled press during the Martial Law period.
“We want to open public access to these materials lalo na yung mga lumang dyaryo para makita ng mga tao na there were actually independent newspapers that covered this time and sila mismo nag-cover down to detail the abuses of the dictatorship habang nasa puwesto [siya],” Suyat said.
According to Amnesty International, around 72,000 were imprisoned, 34,000 were tortured and 3,240 were killed under the martial law rule.
In a span of two months, what used to be a team of two expanded to over 30 youth volunteers, whom Suyat said were not only concerned about preserving history but also fighting against the rampant disinformation online.
In a nation deeply divided by electoral dis- and mis-information, Suyat said their digital archive hopes to democratize martial law-related facts to the public in a matter of a few clicks.
As they nearly complete digitizing their martial law materials, Suyat emphasized the need to ramp up online efforts of debunking lies with facts.
“You use every single part of the archive, kasi that's when we take back the narrative. That's when we take back social media,” he added.
In doing so, Project Gunita is targeting to launch its website and social media pages to the public before Marcos Jr. makes his first state of the nation address at the end of July.
There is also much left to be done in fighting disinformation offline, Suyat said. He encouraged more educators to utilize their online archive in teaching students truthful accounts that transpired during martial law.
“The truth is on our side. Nasa atin yung mga ebidensya, gamitin na natin,” Suyat said. “We will never concede a single page of history.”
COLUMBIA, S.C. (AP) — State Rep. Krystle Matthews on Tuesday won the Democratic nomination to challenge Republican U.S. Sen. Tim Scott of South Carolina, a general election campaign that could begin under the cloud of a possible ethics investigation.
Matthews, the second-place finisher in a June 14 primary, defeated author and preservationist Catherine Fleming Bruce in the runoff.
Matthews has said she wants to change a toxic culture she says leads senators and others in power to strip away the rights of minorities and those who are in the most need of protection.
Over the weekend, conservative activist group Project Veritas published leaked audio of Matthews speaking to an inmate about funding her campaign with “dope boy money” and having Democrats run as Republicans, saying “secret sleepers” represent “the only way you’re gonna change the dynamics in South Carolina.”
On Tuesday, Matthews confirmed to The Associated Press that it was her voice on the tape but said the edited audio of a “tongue-in-cheek” exchange didn’t reflect the full picture.
“That’s the problem, when you have a private conversation, where people don’t have any context,” she said. “I am not advocating for any illegal activity in campaigns.”
Officials with the state House Ethics Committee said Tuesday they could launch a probe based off the audio leak, about which Matthews said she was “not worried.”
“People of South Carolina want somebody authentic and real,” Matthews told AP. “They are tired of people posing to be caring, posing to be intelligent, posing to be kind, and then finding out later on down the road that these people don’t even show up for them.”
Matthews also will run in November for a third state House term if she loses the U.S. Senate race.
In an emailed statement, state GOP Chairman Drew McKissick congratulated the “radical Democrat” Matthews, adding that Republicans “can't wait to demonstrate her stark differences” from Scott.
The incumbent, who has been one of South Carolina’s more popular politicians, had no primary opposition and has raised $44 million for his pursuit of a second full six-year term.
Bruce and Matthews have raised a combined $131,000, according to federal fundraising data.
Scott, the Senate’s sole Black Republican, has said this will be his last term if he is reelected. He won a 2014 special election and his 2016 regular term by more than 60% of the vote.
One of the GOP’s go-to standouts particularly on race and policing issues, Scott has faced a Black opponent in each of his three campaigns. He was a congressman when then-Gov. Nikki Haley appointed him to the Senate seat left open when Jim DeMint resigned in 2012.
Scott is also being touted by some as a potential 2024 presidential candidate, although he has not mentioned it himself.
Scott received former President Donald Trump's “complete and total endorsement” last year. In the Senate, Scott often aligned with Trump, voting with him nearly 91% of the time, according to FiveThirtyEight.
Scott's launch video featured plaudits from former Trump administration officials who could potentially be part of a GOP presidential field with Scott, including former Haley — who served as Trump's U.N. Ambassador — former Vice President Mike Pence and former Secretary of State Mike Pompeo.
Scott touts his conservative credentials and got a primetime speech at the 2020 Republican National Convention. But he has also noted his work with Democrats on police reform legislation.
Meg Kinnard can be reached at: http://twitter.com/MegKinnardAP.
Copyright 2022 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.
INTRODUCTION
Section:
Falling costs of genetic testing in combination with growing public interest in personal genomics has driven the expansion of direct-to-consumer (DTC) genetic testing. Today’s market encompasses a broad range of offerings, from tests that pair users with wines to tests that reveal serious disease risks.1 This review focuses on one area of the rapidly expanding DTC market—genetic testing for cancer susceptibility. Within this space, DTC offerings vary considerably in size and scope. The narrowest is a test that screens for three specific mutations in two genes and the broadest is a whole-genome sequencing service that analyzes dozens of genes for mutations that could affect cancer risk.
Traditionally, DTC genetic tests were advertised—and sold—to consumers without involving a health care professional; however, in accurate years, a new model of testing has come to dominate the market. In this model, tests are advertised to consumers but ordered by licensed physicians.2-5 A number of companies even allow consumers to choose between having tests ordered by their own physician or by a company-provided independent physician.
In both the academic literature and the popular media, there is a lack of clarity about which genetic tests count as DTC offerings.6 This uncertainty, as Hogarth et al7 explain, stems from ambiguity about the meaning of direct-to-consumer, a term that “has been used variously to refer to both advertising and sale of genetic tests.” According to the US National Institutes of Health (NIH), DTC genetic tests “are marketed directly to customers via television, print advertisements, or the Internet, and . . . can be bought online or in stores.”8(p163) Under this expansive definition, tests that are advertised to consumers but ordered by licensed physicians—often referred to as the hybrid model—fall within the ambit of DTC genetic testing.2,5
CONTEXT
Key Objective
To provide an overview of available direct-to-consumer (DTC) genetic tests for cancer susceptibility and to identify six aspects of the testing process that could affect consumers’ ability to make informed decisions about testing and interpret their results.
Knowledge Generated
Recent years have seen DTC genetic testing for cancer susceptibility change dramatically. Specifically, a new model now dominates the market where tests are advertised to consumers but ordered by physicians. Moreover, many of today’s tests are distinguished from earlier DTC offerings for cancer susceptibility by their scope and potential clinical significance. This review provides a comprehensive overview of available DTC genetic tests for cancer susceptibility and identifies aspects of the DTC testing process that could affect consumers’ ability to make informed decisions about testing and understand their results. Given how the DTC genetic testing market for cancer susceptibility has changed in accurate years, it is essential that health care professionals and researchers working in this space appreciate both the range of tests being offered and the challenges that consumers may face as they navigate this evolving landscape.
Relevance
On the basis of our review of companies’ Web sites, consumers would benefit from more information about certain aspects of the testing process. Providing this information would help consumers make informed decisions about whether to use a particular DTC genetic testing service and, should they choose to pursue testing, understand the implications and limitations of their results.
Other than the shift toward physician-ordered testing, many of today’s tests are distinguished from their predecessors by their scope and potential clinical significance. Previously, in the mid-to-late 2000s, most DTC tests used single-nucleotide variation profiling to assess cancer risk, a process that involves screening a DNA trial for single-nucleotide polymorphisms (SNPs)—single base-pair differences that occur at specific positions in the genome—that may affect cancer risk.9,10 Single-nucleotide variation profiling, however, tends to have low predictive value for disease risk and limited usefulness in improving health outcomes (ie, clinical utility).
Today’s DTC companies have largely moved away from using single-nucleotide variation profiling. Instead, they tend to analyze specific genes for mutations that increase cancer risk. Yet this change has not eliminated uncertainty in cancer susceptibility genetic testing. For many of the genes included in larger tests, a positive result may be associated with uncertain risk estimates and/or unclear medical management strategies.11,12
Given how the DTC genetic testing market for cancer susceptibility has changed in accurate years, it is essential that health care professionals and researchers working in this space appreciate both the range of tests being offered and the challenges that consumers may face as they navigate this evolving landscape. Part I of this paper provides an overview of available DTC genetic tests for cancer susceptibility as of July 2019. For each test, we discuss cost; who orders it; whether variants of uncertain significance (VUS) are returned; availability of genetic counseling; intended users; whether consumers are recontacted about variant reclassifications; whether the test is characterized by the company as being diagnostic, actionable, and clinically valid; molecular technique used to analyze DNA; and whether the test is Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited.
In Part II, we identify six aspects of the testing process that we believe could affect consumers’ ability to make informed decisions about testing and understand the implications—and limitations—of their results.13 These are: how companies use certain terms (eg, medical grade or clinical grade); how companies use consumers’ health information during the ordering process; the extent of genetic counseling provided by companies; companies’ procedures for returning results; the role of company-provided ordering physicians; and companies’ procedures for communicating variant reclassifications. On the basis of our review of companies’ Web sites, we believe that consumers would benefit from more information about these aspects of testing.
PART I: DTC GENETIC TESTS FOR CANCER RISK
Section:
Here we describe the array of DTC genetic tests for cancer susceptibility that were on the market as of July 2019 (Table 1). Given the Internet-based nature of DTC genetic testing, today’s consumers primarily receive and interact with DTC companies’ offerings through their Web sites. Thus, to better capture the information that consumers are likely to access when deciding whether to use a test, we only include information about testing services that is, or was, available on companies’ Web sites. It is worth noting that some companies do not explicitly define the terms diagnostic, actionable, or clinically valid. Whereas we describe how each company characterizes these terms and indicate when definitions are absent, inasmuch as our objective is to convey what companies report on their Web sites, we do not evaluate the accuracy of their claims.14
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23andMe
In 2013, the US Food and Drug Administration (FDA) issued a warning letter to 23andMe (Sunnyvale, CA) ordering the company to discontinue marketing its Personal Genome Service, which included reports for several hundred diseases and conditions, an SNP-based risk score for breast cancer, and a limited BRCA1/BRCA2 test.15 According to the FDA, 23andMe had failed to demonstrate that its service could correctly identify genetic disease risks, made misleading claims about the health benefits of tests, and failed to comply with the premarket review process for medical devices.16
Since that time, 23andMe has substantially revised its services. In March 2018, the FDA authorized 23andMe to market a BRCA test that screens for three specific BRCA1/BRCA2 variants, making it the first FDA-authorized DTC genetic test to report on cancer risk.17,18 Although there are more than 1,000 known BRCA1/BRCA2 mutations that are associated with an increased risk of breast and ovarian cancer, 23andMe’s test only screens for three founder mutations—two in the BRCA1 gene (BRCA1 c.68_69delAG and BRCA1 c.5266dupC) and one in the BRCA2 gene (BRCA2 c.5946delT)—that are found almost exclusively in individuals of Ashkenazi Jewish descent.17 The test, therefore, is unlikely to be useful to individuals from other ethnic backgrounds.19,20 As 23andMe acknowledges, its BRCA screen is not comprehensive and does not rule out the possibility that an individual carries one of the many BRCA1/BRCA2 mutations not covered by its report.21
In January 2019, 23andMe received FDA clearance to expand its cancer susceptibility testing to report on two MUTYH genetic mutations that are implicated in MUTYH-associated polyposis, an autosomal recessive hereditary colorectal cancer syndrome.22 The two variants that are included in the test—p.Y179C and p.G396D—are the most common pathogenic MUTYH mutations in individuals of northern European descent, although there are more than 100 pathogenic MUTYH variants.23 In the general northern European, Australian, and US population, the heterozygous carrier frequency for a pathogenic MUTYH variant is 1% to 2%.2 Individuals with a single MUTYH mutation are thought to have a slightly increased risk of colorectal cancer relative to the general population lifetime risk—approximately 4%.25-27 In contrast, individuals carrying mutations in both MUTYH alleles have a much higher cumulative risk of colorectal cancer—approximately 80% by age 70.28
23andMe’s BRCA report is included with its Health + Ancestry Service.29 Excluding special offers, the service costs $199. Consumers order their own tests and receive their results through an online account. If a consumer does not wish to view his or her BRCA result, they can opt to exclude it from the report. Although the company does not provide genetic counseling, consumers are encouraged to consult with a genetic counselor before and after testing. 23andMe uses genotyping to analyze DNA. The company states that its BRCA test meets FDA requirements for clinical validity, which it defines as “the degree to which a test accurately identifies or predicts a disease of interest.”30 23andMe maintains that its BRCA test “is not intended to diagnose any disease and does not describe a person’s overall risk of developing any type of cancer.”22 It also maintains that the test is not medically actionable and that “[r]esults should be confirmed in a clinical setting before taking any medical action.”22 All DNA samples are processed in CLIA-certified and CAP-accredited laboratories.
Veritas Genetics
Veritas (Santa Clara, CA) offers a whole-genome sequencing service called myGenome Standard that costs $599. For an additional $1,000, consumers can upgrade to myGenome Premium, which includes more diseases and carrier conditions. myGenome (standard and premium) can be ordered by the consumer’s own provider or, for an additional $129, by an independent physician affiliated with the telegenomics company Genome Medical. When the results are ready, Veritas notifies the consumer and the ordering provider, both of whom can then access the report through Veritas’ Web portal. If interested, consumers can pay an additional $99 to receive their raw data.
For myGenome (standard and premium), pathogenic and likely pathogenic results are reported, and benign, likely benign, and VUS results are not typically returned. Veritas does not state whether it will contact the ordering provider or the consumer about variant reclassifications. Through Genome Medical, Veritas offers a complimentary 30-minute return of results genetic counseling session for clinically actionable findings. Consumers can also pay $299 for Comprehensive Genetic Counseling, which includes access to pretest counseling and a 60-minute post-test session to review results.
According to Veritas, its service is intended to be a screening test for healthy individuals; however, myGenome is not meant to be diagnostic because “there is a chance that some of the variants that are associated with health conditions or disease risk could be missed.”31 As such, the test “should not be used to diagnose a known or suspected heritable disease in [the consumer] or [the consumer’s family].”32 Veritas does not state whether myGenome is a clinically valid test. It does, however, characterize myGenome as providing information that may “affect [the consumer’s] health and [is] actionable, be it with changes in diet and activity level, medical screenings, or enhanced vigilance.”33 Nevertheless, it is not clear that Veritas’ findings, at least by themselves, are intended to inform clinical care.34 This interpretation is supported by the company’s informed consent document, which states that “all variants considered clinically relevant in [the consumer’s] report should be confirmed with secondary testing before changes to [the consumer’s] healthcare are made.”32 Veritas uses next-generation sequencing to analyze DNA. The company’s US laboratory is CLIA certified and CAP accredited.
Invitae Corporation
Invitae (San Francisco, CA) offers a cancer susceptibility panel—Invitae Cancer Screen—that consists of 61 genes associated with 10 types of cancer (breast, colorectal, gastric, ovarian, pancreatic, prostate, renal cell, thyroid, uterine, and cutaneous melanoma). In addition, Invitae offers cancer susceptibility testing as part of its Genetic Health Screen, which consists of a 147-gene panel that also analyzes genes related to cardiac diseases and other inherited conditions. Neither test is intended to be diagnostic; both are considered proactive services that are intended for healthy adults without a strong personal or family history of cancer.
Invitae’s Cancer Screen and Genetic Health Screen cost $250 and $350, respectively, and can be ordered by the consumer’s own provider or by a company-provided physician. The ordering provider is notified via e-mail when the results are ready and receives a written report. Consumers who have their test ordered by an independent physician receive an e-mail when the results are ready, at which time they can review their results and schedule an appointment with one of Invitae’s genetic counselors. Post-test genetic counseling is available at no additional cost.
Invitae uses next-generation sequencing and does not report VUS findings for proactive tests. However, if a VUS is reclassified to likely pathogenic or pathogenic, Invitae will inform the ordering physician and issue an updated report. Invitae does not say whether it will contact the ordering physician and issue an amended report for other variant reclassifications. The company also does not state whether either proactive test is clinically valid, although it does provide links to validation studies.35 Regarding actionability, Invitae maintains that consumers can “take action based on [their] results” and “work with [their] provider to consider: increased or earlier screenings, lifestyle modifications, and early intervention to prevent the onset of disease.”36 Invitae’s laboratory is CLIA certified and CAP accredited.
Color Genomics
Color Genomics (Burlingame, CA) offers a test called Color Extended that analyzes genes related to cancer, cardiac disease, and medication response. The test costs $258.95 and includes 30 cancer predisposition genes associated with eight types of cancer (breast, ovarian, uterine, colorectal, melanoma, pancreatic, stomach, and prostate). Color Extended can be ordered by either the consumer’s own provider or by a company-provided independent physician at no additional charge. If the consumer’s own provider orders the test, the provider can choose whether the results are released to the consumer as soon as they are ready or after a delay. For tests that are ordered by an independent physician, information about the process for returning results is not available on the company’s Web site. Consumers who wish to discuss their results can access complimentary genetic counseling.
Color uses next-generation sequencing and reports VUS findings. If a VUS result is reclassified, Color will attempt to recontact the consumer. The company does not state whether Color Extended is a clinically valid test in its entirety. However, there is a section on the Web site where Color discusses the clinical validity of its tests with respect to certain conditions.37 Color Extended is described as being actionable, meaning that the consumer can “work with [their] healthcare provider to create a personalized screening and prevention plan, designed to reduce [their] risk of developing cancer.”38 Color maintains that its test is not diagnostic because “[p]ositive results do not necessarily mean that [the consumer] [has] that hereditary disorder or that [the consumer] will develop the disorder in [their] lifetime” and “[n]egative results do not eliminate [the consumer’s] risk of developing a disorder, and do not guarantee that [the consumer] will be healthy or will never develop any of the disorders that Color tests for.”39 Color’s laboratory is CLIA certified and CAP accredited.
Helix
Helix (San Carlos, CA) offers two tests—GenePrism and Prostate Cancer Genetic Risk Score—that evaluate cancer susceptibility. Whereas both tests are sold by Helix, GenePrism is administered by PerkinElmer Genomics, and Prostate Cancer Genetic Risk Score is administered by NorthShore University HealthSystem. The tests can only be ordered by a physician who is affiliated with the relevant partner company.
GenePrism analyzes the 59 genes included in the American College of Medical Genetics and Genomics’ list of actionable genes, of which 26 are associated with an increased risk of cancer.40 The test costs $299.99, including a $30 fee that covers the ordering physician and genetic counseling services. The test is “intended to provide proactive health insights for those who do not have a significant family history associated with the health conditions that it includes.”41 The consumer is notified by e-mail when the results are ready to be accessed through the GenePrism Web site. Helix does not explicitly state whether the test is clinically valid. GenePrism is not a diagnostic test and “is not intended to diagnose any medical conditions” and “will not tell you if you currently have one of the conditions covered by the test, or if you definitely will or will not develop the condition in the future.”41 The test does not report VUS results. Helix describes the test as actionable, which, according to the company, means that “if [the consumer] learn[s] of a genetic risk from the test, [the consumer’s] risk is significantly increased over the general population, and there are actions [the consumer] or [the consumer’s] doctor can take to reduce [the consumer’s] risks based on established medical recommendations.”41 Helix does not explain its procedures for recontacting consumers about variant reclassifications, although the company does maintain that “[r]esults may change as research continues to allow us to better interpret what these and other genes mean for health.”41
Prostate Cancer Genetic Risk Score is an outlier among DTC cancer susceptibility tests. Unlike other tests that focus on single-gene mutations, Helix’s test provides a polygenic risk score based on an analysis of numerous SNPs that affect prostate cancer. The test costs $239.99, which includes a $40.00 fee that covers the ordering physician and genetic counseling services. Helix does not state whether the test is intended for individuals with a personal and/or family history of prostate cancer. Results are returned through secure e-mail. Helix maintains that the test is not a diagnostic product because “[a]n estimate of [the consumer’s] risk does not determine if [the consumer] will or will not get prostate cancer.”42 Helix does not state whether the test is clinically valid or whether results are medically actionable.
Helix uses next-generation sequencing to analyze DNA. For both GenePrism and Prostate Cancer Genetic Risk Score, genetic counseling is available through Genome Medical at no additional charge. Helix’s laboratory is CLIA certified and CAP accredited.
PART II. ASPECTS OF TESTING THAT COULD AFFECT INFORMED DECISION MAKING AND THE INTERPRETATION OF RESULTS
Section:
Meaning of Terms
In describing their offerings, several companies use terms that they do not clearly define. For example, Invitae characterizes its proactive tests as medical grade and diagnostic grade. Except to say that its proactive tests “offer the same clinical quality as a diagnostic test,” the company does not explicitly define either of these terms.43 Similarly, Color characterizes its offering as an “affordable clinical-grade test,” but does not specify what the term clinical grade means. Of note, despite describing these tests as medical, diagnostic, or clinical grade, both Invitae and Color maintain that their services are not intended to be diagnostic.39,43 Consumers who are unclear about the meanings of these terms, none of which are scientific or medical designations, may struggle to understand why a test that is marketed as medical-, diagnostic-, or clinical grade should not be used in a diagnostic capacity.
In addition, given that tests are often characterized as being medical, diagnostic, or clinical grade, consumers may wonder whether their results could expose them to potential insurance discrimination. According to the Genetic Nondiscrimination Act (GINA), it is illegal for US health insurance providers to use genetic information, including from DTC tests, to deny coverage or increase premiums. GINA, however, does not apply when an employer has fewer than 15 employees or to other forms of insurance (eg, disability insurance, long-term care insurance, and/or life insurance).44 Although all of the companies seem to provide some information on their Web sites about genetic discrimination, discussions about how consumers’ results could affect their access to different types of insurance is often covered during pretest counseling, which may be lacking in the DTC setting.
Companies could also be more transparent about whether their tests can accurately predict an individual’s risk of developing a particular disease—that is, whether they are clinically valid. Most DTC cancer susceptibility genetic tests analyze an array of genes that encompass a wide range of risk estimates. Whereas some of the genes included in these tests have well-established risk estimates, not all do. For example, Color and Veritas’ tests include the MITF gene.45,46 Although MITF mutations are suspected to increase the risk of melanoma and renal carcinoma, the extent to which a mutation carrier’s risk is elevated remains unclear.45,47 Overall, consumers might benefit from greater clarity about which genes in a test are considered clinically valid. Providing this information in a transparent and accessible manner could help consumers decide whether to pursue a test that may include genes with low predictive value for cancer risk.
Use of Consumers’ Health Information
Companies with testing services that can be ordered by a company-provided physician often ask consumers to answer a set of questions about their personal and family health history; however, it is not always clear how ordering physicians use this information. For example, Veritas maintains that consumers’ responses to these questions “are necessary to sequence [their] DNA and also helps [Veritas] better interpret [their] results.”48 Nevertheless, Veritas does not clarify how this information factors into the ordering process. As consumers consider whether to purchase a test, they may be interested in learning how their health information will be used. In particular, they might want to know whether the physician will follow up to discuss their health history before ordering testing. Consumers might also wonder whether company-provided physicians ever decline to order testing and, if so, for what reasons.
Genetic Counseling
Although all of the companies that offer physician-ordered DTC genetic tests seem to provide genetic counseling in some capacity, the extent, timing, and cost of these services is sometimes unclear. For example, Invitae maintains that “[o]ur team of board-certified genetic counselors is available on demand by phone during business hours to assist you with general questions about genetic testing and your results.”49 What remains unclear (for Invitae and some of the other companies) is the extent to which pretest counseling is comprehensive and individualized. In the clinical setting, pretest counseling is widely regarded as an important part of obtaining informed consent to testing.50,51 Companies could therefore help consumers make informed choices about whether to pursue DTC testing by including more information on their Web sites about pretest counseling.
Currently, companies differ in terms of how they provide genetic counseling. Helix, for example, outsources its genetic counseling to Genome Medical, which is a distinct corporate entity from Helix.41 Other companies, such as Invitae, offer in-house counseling that includes pretest counseling.49 This arrangement raises potential ethical concerns about whether a conflict of interest arises when companies provide pretest counseling services for their own tests.52,53
Procedures for Returning Results
Most of the companies that offer tests through the physician-ordered model do not include a detailed description of their process for returning results. On the basis of the companies’ online materials, it may not be clear whether procedures vary depending on the clinical significance of consumers’ results. Are positive and VUS results disclosed over the phone by a genetic counselor, while negative results are delivered through an online portal? Again, providing more information could help consumers make informed decisions about whether they are comfortable with a company’s model for returning results.
Role of Company-Provided Physicians
For some of the companies that offer company-provided independent physicians, it is unclear what role, if any, these physicians play beyond simply ordering tests. It is also not clear how companies conceive of the relationship between consumers and these physicians, some of whom may belong to an external physician network or separate company.54 For example, Helix states that the company “will share [the consumer’s] contact information and health history with PerkinElmer Genomics so a physician they designate can review and make sure this product is right for [the consumer].”41 Consumers may wonder whether they can contact the ordering physician with additional questions about the test or their results. Notably, will the ordering physician assume responsibility for a consumer’s follow-up care or refer the consumer to another provider? As of now, these questions are not easily answerable from companies’ online materials.
Variant Reclassification
As scientific understanding of variant pathogenicity evolves, genetic test results may be amended. Some changes could have significant clinical implications for disease risk and medical management (eg, a VUS that is upgraded to pathogenic). Nevertheless, information about companies’ procedures for handling amended results may not be readily available. Color’s Informed Consent, for instance, lacks specific information about how the company manages variant reclassification beyond stating that it may “at its sole discretion, amend or modify [the consumer’s] Test report” and will “attempt to notify (the consumer) of any material amendments or modifications.”39 Some companies, however, do not provide any information about variant reclassification. Helix’s informed consent, for instance, notes that “future information may change your results,” but does not specify whether the company monitors for variant changes or notify consumers about them.55 Given the potential clinical significance of variant reclassifications, consumers could benefit from more information about companies’ procedures for tracking variant changes and sharing amended results.
In conclusion, genetic testing for cancer susceptibility, once limited to the clinical setting, is now widely available through Web-based DTC genetic testing companies. To better understand whether test takers are knowledgeable about companies’ testing procedures, there is an urgent need to collect and study consumer outcome data.13 As the DTC market continues to evolve, outcome data should inform companies’ products and practices to ensure that consumers are equipped to make informed decisions throughout the testing process and understand their results.
A Catholic archbishop called on newly sworn-in President Ferdinand Marcos Jr. not to fail the people, especially those who supported him.
Archbishop Marlo Peralta of Nueva Segovia in Ilocos Sur, in a Radio Veritas interview, urged Marcos to prioritize public welfare above everything in his administration.
“Please, Mr. President, do not fail them,” Peralta said, “especially those who are struggling every day to meet the needs of their families.”
“I pray that you’re always aware that the majority of the Filipino people are poor and they look up to you to uplift their lives,” he said.
The archbishop also assured his prayers for the success of the Marcos administration.
“With sincerity and good will, I pray that you’ll succeed in your presidency,” Peralta added.
Marcos hails from Ilocos Norte having previously served as its governor, vice governor and congressman. CBCP NEWS
Image credits: PAUL PETER VALDEPEÑAS
