As demand for DTC at-home genetic testing increases among consumers and healthcare professionals, clinical laboratories that offer similar assays may want to offer their own DTC testing program
Things are happening in the direct-to-consumer (DTC) medical laboratory testing market. Prior to the pandemic, the number of consumers interested in ordering their own diagnostic tests grew at a rapid rate. The SARS-CoV-2 outbreak, however, and the need for consumers to access COVID-19 tests, caused DTC test sales to skyrocket.
One company benefiting from the DTC trend is New York City-based LetsGetChecked. In March, it announced its acquisition of Veritas Genetics which included that company’s Veritas Intercontinental business division. No purchase price was disclosed.
LetsGetChecked describes itself as a “virtual care company that allows customers to manage their health from home, providing direct access to telehealth services, pharmacy, and [clinical] laboratory tests with at-home sample collection kits for a wide range of health conditions,” according to the company’s LinkedIn page.
“Through these acquisitions, LetsGetChecked will leverage the power of whole genome sequencing to launch a full lifecycle of personalized healthcare, delivering the most comprehensive health testing and care solution on the market,” said Peter Foley, Founder and CEO of LetsGetChecked in a press release.
“By integrating Veritas Genetics’ and Veritas Intercontinental’s capabilities with LetsGetChecked’s scalable diagnostic and virtual care infrastructure, we are able to turn comprehensive genetic insights into practical recommendations and lifestyle changes, guided by clinical experts,” he added.
“Our mission to deliver the benefits of whole genome sequencing to millions of individuals continues as part of the LetsGetChecked family. I am particularly excited about the opportunity to combine genetic testing with the broad spectrum of virtual and at-home care models offered by LetsGetChecked. I expect these acquisitions will change the future of personalized healthcare as we know it,” said geneticist George Church, PhD, co-founder of Veritas Genetics, and Professor of Health Sciences and Technology at Harvard and MIT, in a press release. (Photo copyright: Wyss Institute at Harvard University.)
Leveraging the Power of Whole Genome Sequencing
To date, LetsGetChecked claims it has delivered nearly three million at-home direct-to-consumer tests and served more than 300 corporate customers with testing services and biometric screening solutions since its founding in 2015.
The company focuses on manufacturing, logistics, and lab analysis in its CAP-accredited, CLIA-certified laboratory in Monrovia, Calif., as well as physician support, and prescription fulfillment. The DTC company’s products include at-home tests for women’s health, men’s health, basic wellness, sexual health, and SARS-CoV-2 testing.
Veritas Genetics also was a DTC testing company co-founded by internationally-known geneticist George Church, PhD. In 2016, the company announced it would deliver a whole human genome sequence (WGS) for just $999—breaking the $1,000 cost barrier for whole genome sequencing.
“There is no more comprehensive genetic test than your whole genome,” Rodrigo Martinez, former Veritas Chief Marketing and Design Officer, told CNBC. “So, this is a clear signal that the whole genome is basically going to replace all other genetic tests. And this [price drop] gets it closer and closer and closer.”
That market strategy did not succeed. By the end of 2019, the company announced it would cease operations in the United States but continue operations in Europe and Latin America. It has sought a buyer for the company since that time. Now, almost three years later, LetsGetChecked will become the new owner of Veritas Genetics.
Veritas’ primary product, myGenome was launched in 2018 as a whole genome sequencing and interpretation service to help consumers improve their health and increase longevity. The myGenome test screens for and provides insight on many hereditary diseases such as cancer, cardiovascular disease, and neurological disorders. It also provides observations on more than 50 personal traits and ancestry information.
In addition to bringing whole genome sequencing abilities to its test offerings for consumers, LetsGetChecked hopes the acquisitions will create new testing capabilities such as pharmacogenomics, cancer and viral screenings, and maternal fetal screenings.
“By integrating Veritas Genetics’ and Veritas Intercontinental’s genetics offering with our scalable virtual care infrastructure, we are able to leverage the power of whole genome sequencing to launch a full lifecycle of personalized healthcare, which has always been our goal,” Foley told MobiHealthNews.
Veritas Genetics and Veritas Intercontinental will continue to operate under the LetsGetChecked family of companies.
BioIQ also Acquired by LetsGetChecked
In early May, LetsGetChecked also acquired diagnostic testing and health improvement technology company BioIQ, which will continue to operate as a wholly-owned subsidiary.
BioIQ offers at-home tests, health screenings, and vaccinations to consumers. The company’s products include:
Heart health panel,
Lipid panel,
Respiratory panel,
Prevention panel, and
Wellness panel.
Individual tests offered by BioIQ include:
A1C,
COVID-19,
Hepatitis C test and
Sexually transmitted diseases.
BioIQ also offer e-vouchers for health screenings and vaccinations at participating retail pharmacies, clinical laboratories, and physician’s offices.
“The future of healthcare is in providing high-quality at-home diagnostics and care that comprehensively serve an individual’s health needs throughout their whole life,” said Foley in a press release about the BioIQ acquisition. “With this acquisition, LetsGetChecked gains a trusted partner with an extensive knowledge base and a breadth of experience in serving health plans and employer markets to deliver healthcare solutions at scale.”
These acquisitions by LetsGetChecked demonstrate how genetic testing companies are pivoting to new strategies. Clinical laboratories that perform genetic testing will want to monitor how these partnerships unfold in the future as healthcare consumers and providers continue to embrace at-home genetic testing.
Because air travel volumes are low, experts believe it is timely to develop COVID-19 testing systems and gain insight on which protocols are most effective
As the COVID-19 pandemic surges on, several international airlines now require customers to complete at-home COVID-19 testing before they can travel. This is triggering unusual business practices. For example, one airline allows its passengers to use frequent flier miles to purchase mail-in COVID-19 test kits.
Frequent Flyer Miles for COVID-19 Testing
Across the United States, Hawaii has one of the lowest rates of infection, partly thanks to the state’s strict quarantine regulations. In a state, however, that depends on tourism for its economic health, the pandemic has caused serious financial difficulties. In an effort to prevent spread of the coronavirus while also encouraging tourism, Hawaiian Airlines now offers “Pre-travel COVID-19 Test Options” on its website.
To be allowed to skip the state’s mandatory 14-day self-quarantine before arriving on the islands, flyers can take a pre-travel coronavirus test with the following conditions:
The test must be from a state-approved testing provider.
The test must be administered no more than 72 hours prior to the scheduled departure time of the final leg to Hawaii.
For trans-pacific travel, test results must be received prior to flight departure.
Additionally, the airline accepts frequent flyer miles to pay for mail-in COVID-19 tests. In exchange for 14,000 HawaiianMiles, a passenger receives a test kit in the mail. The kit features a video call during which a healthcare professional guides the consumer on taking a saliva sample. The user then ships the sample to a qualified clinical laboratory. Results are returned electronically within 24 hours of the lab receiving the sample.
Hawaii’s COVID-19 portal states, “The state of Hawaii will ONLY accept Nucleic Acid Amplification Test (NAAT) from a certified Clinical Laboratory Improvement Amendment (CLIA) lab test results from Trusted Testing and Travel Partners” that are participating in the state’s pre-travel testing program. Honolulu and Maui are the only two arrival airports allowed. A negative result must have come from a test performed within 72 hours prior to the final leg of the passenger’s trip to Hawaii, according to the portal.
“A negative pre-travel test is an alternative to two weeks in self-isolation for arrivals to the archipelago,” the UK’s Independent reported.
JetBlue and Vault Health Partner to Offer COVID Testing to Airline Passengers
In another instance of an airline getting involved in at-home testing, JetBlue (NASDAQ:JBLU) is partnering with Vault Health to offer at-home testing. The process is similar to the Hawaiian Airlines program. However, rather than purchasing the test with frequent flyer miles, JetBlue offers polymerase chain reaction (PCR) tests at a discount.
Business Travel News reported that passengers must provide a confirmation code while ordering the $119 test from Vault Health’s webpage. “Vault provides a kit for an at-home saliva test, and users administrate it while on a video chat supervised by Vault to ensure the test is done properly. The user sends it overnight to a clinical laboratory and the results are provided within 72 hours,” Business Travel News stated.
“We continue to hear from health officials that [COVID-19] testing is incredibly important in the fight against the coronavirus, and we want to make sure our customers have options for testing, especially prior to travel,” said Joanna Geraghty, President and Chief Operating Officer, JetBlue, in a press release. “As more and more regions reopen, many are requiring test results to enter. Now with easier testing options, those safety requirements may not be a deterrent for travel, but rather provide greater public health and peace of mind with little inconvenience.” (Photo copyright: Spectrum News NY1.)
In addition to airlines such as Hawaii Airlines and JetBlue instituting programs for coronavirus testing, some airports are as well. Tampa International Airport, for example, test-piloted a voluntary testing program for all arriving and departing passengers from October 1st to October 31st. The airport partnered with BayCare, a 15-hospital Tampa area healthcare network, to provide both rapid antigen and PCR tests.
“Testing services will be offered on a walk-in basis … seven days a week from 8 a.m. until 2 p.m. The pilot will be open to all ticketed passengers who are flying or have flown within three days and can show proof of travel. The PCR COVID-19 test costs $125 and the antigen test costs $57,” a press release stated.
Tampa Airport CEO Joe Lopano told the Washington Post, “This could be—especially if adopted by other airports—another way to instill confidence.”
COVID-19 Testing by Retailers Expanding as Well
Travelers aren’t the only people who need testing. Some employers also are requiring negative tests before employees can return to work.
As with all at-home kits, the consumer collects their own specimen and sends it off to a qualified clinical laboratory for processing. AZOVA, a telehealth company, supplies the kits to Costco for resale and provides a smartphone app where customers can check and display the test results.
P23 Labs’ TaqPath SARS-CoV-2 assay is the test being used, which, according to P23, “has a 98% sensitivity and 99% specificity,” Business Insider reported.
The researchers found that “All seven SARS-CoV-2 genomes were genetically identical, with the exception of a single mutation in one case, and all genomes had five signature mutations seen in only six other genomes from the >155,000 genomes sequenced globally. Four of these six related genome sequences were from Switzerland, the country of origin of the suspected index case.”
They added, “By combining information on disease progression, travel dynamics, and genomic analysis, we conclude that at least four in-flight transmission events of SARS-CoV-2 likely took place.”
At-home test kits for COVID-19 are here to stay. That large businesses in multiple industries are now partnering with COVID-19 test developers and clinical laboratory companies to accomplish testing of customers and employees means independent labs that process coronavirus testing can look forward to increasing COVID-19 testing business.
“We need to be using the time now, when [travel] volumes are relatively low, to test the systems and gain insight on which protocols are most effective,” Mara Aspinall, biomedical diagnostics professor at Arizona State University, President and CEO of the Health Catalysts Group, an investment and advisory firm, and former President/CEO of Ventana Medical Systems (now Roche Tissue Diagnostics), a billion-dollar division of Swiss pharmaceutical and diagnostics manufacturer Roche, told the Washington Post.
Genetic counselors struggle to explain direct-to-consumer genetic test data—or correct provider misinterpretations of results—while often encountering resistance and anger from patients who don’t accept their counseling
Healthcare consumers who want to know more about their family’s genealogy are purchasing direct-to-consumer (DTC) home genetic tests in record numbers. It is a trend that worries some medical laboratory professionals and certain federal government agencies.
MITTechnology Review (MIT) dubbed 2017, “The year consumer DNA testing blew up.” As a result of record-breaking sales of DTC genetic testing last year, about 12-million people have now been tested, MIT reported. “The inflection pointed started in the summer of 2016, and from there it’s gone into the stratosphere,” David Mittelman, PhD, Molecular Biophysics, told MIT.
Clearly, consumers are becoming comfortable with the concept of genetic testing on themselves and their family members. However, major issues—such as who owns genetic information and how patient privacy is protected—have yet to be resolved.
Dark Daily recently reported that more than 1.5 million kits were sold by Ancestry.com during the four-day Black Friday/Cyber Monday weekend prior to Christmas 2017. That e-briefing also explored related privacy issues and informed readers about efforts by federal lawmakers to explore genetic testing companies’ privacy and disclosure practices.
According to a news release, by the end of November, sales of AncestryDNA kits exceeded the total number of subscribers the Utah-based company had when it started the year. Now, more than seven million people are in Ancestry’s database.
Meanwhile, 23andMe, a personal genomics company established in 2006, has genotyped more than three million people worldwide. In addition to an ancestry test, it offers a health and ancestry service providing information on genetic health risks, carrier status, traits, wellness, and ancestry, according to the company’s website.
Experts Concerned About Privacy and Use of ‘Raw’ DNA Data
“2018 will bring a regular drumbeat of new experiences and enhancements across both DNA and family history,” Howard Hochhauser, Ancestry’s Interim Chief Executive Officer, predicted in the news release.
However, a recent study published in Translational Behavioral Medicine (TBM) which noted the robust sales of DTC genetic tests in 2017, also called attention to a new concern surrounding the impact of “raw” DNA interpretation results.
“People often enter the direct-to-consumer market for recreational purposes, such as learning about their ancestry. Yet, what we started seeing was that these same individuals subsequently come across third-party interpretation services where they proceeded to learn more about their ‘raw’ DNA made available by the ancestry testing companies,” stated Catharine Wang, PhD, Boston University (BU) Associate Professor of Community Health Sciences, and the study’s lead author, in a BU statement.
The study cited sales of DTC genetic tests at $99 million in 2017 and explored potential negative implications of consumers’ access to “raw” DNA data.
“We were especially interested in the downstream implications of receiving unexpected disease risk information from these newer services that subsequently lead consumers to seek out a genetic counselor’s consult,” Wang noted.
Catharine Wang, PhD (above), Associate Professor of Community Health Sciences at Boston University and lead author of the study, notes, “There are a lot of people saying, ‘I’m smart enough to make decisions; give me the information and get the doctors out of the way. But they’re making some serious decisions about their health after seeing only part of the picture.” (Photo copyright: Boston University Research.)
After Getting DNA Data, Consumers Turn to Interpretation Services, Genetic Counselors
The research team surveyed 85 genetic counselors. Fifty-three percent of them reported meeting with DTC test costumers who had accessed ‘raw’ DNA data and used genetic interpretation companies, which are not regulated by the US Food and Drug Administration (FDA), to get more information about themselves. However, results of the sessions were not always positive for either patients or counselors.
According to the study, counselors reported their biggest challenge as “undoing misinterpretations and correcting patient beliefs about their raw DNA results.”
The study noted, “When genetic counselors tried to clarify misunderstandings, patients were not only resistant but sometimes appeared hurt and frustrated that counselors were not taking their results seriously.”
Other negative experiences counselors reported while interpreting “raw” DNA test results for patients include:
“Time required to review and understand interpretation reports;
“Feeling ill equipped and uncomfortable providing the service;
“A lack of supportive organizational structure; and,
“[Having to] correct a patient’s misunderstanding, following a primary care physician’s misinterpretation of her raw DNA results.”
“Counselors expressed concern about the quality of the raw data and the clarity and usefulness of interpretation reports. Efforts to better support both consumers and genetic service providers are needed to maximize the effective translation of genome-based knowledge for population health,” the study authors concluded.
Providers Should Improve Ability to Help Patients with DTC Genetic Data
In a MedCity News blog post, Peter Hulick, MD, Director of Personalized Medicine, NorthShore University HealthSystem, called for healthcare providers to assist patients who are dealing with new DTC genetic services and possible data overload.
“Findings show having widespread access to personal genetic information—without the knowledge of how to interpret results—can lead to problems ranging from misinterpretation to emotional distress,” he noted. “The medical community must work harder and smarter to incorporate this information into practice and empower patients as consumers and partners in healthcare decision-making.”
Anatomic pathologists and clinical laboratory leaders also should acknowledge and monitor consumers’ growing interest in these tests. Once patients’ have their DNA sequenced, the likelihood they will seek to know their predisposition to diseases is high and increasing. Thus, opportunities exist for medical laboratories to help physicians and consumers interpret DTC test results.
Medical labs must comply with PAMA lab test price market reporting in 2017, while pathologists will see big changes in Medicare physician payments because of MIPS
It is now budget-planning season for the medical laboratories of hospital and health systems. This fall, lab administrators report grim news as they try to anticipate all the changes coming to the clinical laboratory industry in 2017—just 11 weeks away.
There is a growing consensus among lab executives and pathologists who are the business leaders of their groups that labs will not see any relief in 2017 to the multi-year decline in lab test prices that actually intensified in the past 24 months.
One factor is their assessment of the coverage and pricing decisions being made by the federal Centers for Medicare & Medicaid Services (CMS) and Medicare Administrative Contractors (MACs) for specialty lab tests. The other factor is their experience with private payers who continue excluding local clinical labs from narrow networks and who insist on price cuts when managed care contracts are renewed. (more…)
