Monday, May 16, 2022

Genetic sequencing opens new doors – and concerns – for home health testing

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At-home health testing company LetsGetChecked has acquired genetic testing company Veritas Genetics and spin-off Veritas Intercontinental. announced on Tuesday. It’s the latest pivot for a direct-to-consumer genetics company, most of which have struggled in recent years to sell DNA testing kits to consumers increasingly concerned about genetic privacy.

Partnering with an industry like home testing, which: grew in the course of the COVID-19 pandemic, there is one way forward. But that integration can create conflicts of interest for patients as a company is incentivized to encourage consumers to test based on their genetic information, experts said The edge† With all these products on board at one company, genetic information — and its limitations — must be communicated very, very carefully.

LetsGetChecked is one of the largest companies under that umbrella, and the company said its revenue grew by 1,500 percent in 2020 and 2021. It already has telehealth services, testing for things like sexually transmitted diseases and cholesterol, and integration with a pharmacy service. By adding genetic services, the company can meet all of a customer’s health needs, CEO Peter Foley said The edge† “It’s the last piece of the puzzle for us,” Foley said.

Founded in 2014 by geneticist George Church, Veritas had early plans to offer low-cost whole genome sequencing to consumers, eventually cutting costs down to $599. Unlike companies like 23andMe and Ancestry, Veritas sequences customers’ entire genome, making it more expensive. Veritas ceased operations in the United States in 2019 after difficulty finding investors and started looking for buyers to bring it back.

Other genetics companies had similar problems. 23andMe laid off 100 employees in early 2020, and sales for both 23andMe and Ancestry were in 2019† 23andMe has since shifted its focus to drug development efforts using its database of genetic information. Related companies, such as the GEDMatch genetic database, have made changes: GEDatch, which helped identify the Golden State Killer, was acquired by a crime-scene DNA company in 2019. bioethicist and associate professor of genetic medicine at Johns Hopkins Medicine.

Veritas had always positioned itself more as a personal health company. Now, the LetsGetChecked acquisition adds it to a range of products that provide consumers with information about their health. Veritas provides people with information about dozens of genes linked to a range of health problems, including cancer risk, heart disease risk, metabolism, cholesterol, hair thickness and pain sensitivity. Neither the genetic tests nor most diagnostic tests are approved by the Food and Drug Administration – because they are designed and offered by a certified lab, they are considered “laboratory developed tests” and can be marketed without it. brought and sold additional supervision.

LetsGetChecked can now tell people their genetic risk for a particular condition and then combine that with diagnostic tests for that condition, Foley says. “We can track it over time. And then we can also provide telehealth infrastructure and a pharmacy business if people need to be treated,” he says.

Offering diagnostic tests after genetic testing can be a helpful tool, says Katherine Wasson, a bioethicist who studies direct-to-consumer genome testing at Loyola University Chicago. “You could say it’s more of a continuous service,” she says.

But it can also be a potential conflict of interest. “The vast majority of the genome is like a weather forecast,” Mathews says. Just as a weather report might tell someone that it might rain in their area, it is no guarantee that it will actually rain. Genes can tell whether someone is more or less likely to have a particular health condition, but in most cases without a high degree of certainty. If the company providing the information also sells diagnostic tests and treatments for the same condition, that could be a conflict — especially if they push people toward those options based on more uncertain genetic information.

Whether it’s a helpful collaboration or a potential problem depends on how the genetic information is presented to customers, Wasson says. Ideally, they would have experts helping people process and understand their results and guide them through their next steps. There also needs to be clarity about the ways in which diagnostic test results differ from genetic test results, Mathews says — they may need to be explained or presented in a different way.

The more uncertainty there is around a test result, the more important clear communication becomes. That gap was seen in a study of blood tests on pregnant people to find developmental disabilities: The test results were often inaccurate, but they were marketed to consumers with language like “highly accurate” and “total confidence.”

Foley says LetsGetChecked will add genetic counselors to its team along with the new service, and consultation services will be available through the testing process. “Nobody is looking at it alone for the first time. They get that extra support,” he says. “We make sure that people fully understand the results.”

The risks and benefits of combining these types of services depend on implementation, Wasson says. “You really have to see how it’s done,” she says.

It’s important to keep a close eye on how these partnerships are progressing as consumer genetics testing companies shift to new strategies. Mathews will look at how the genetic data is shared and used by the new companies taking on that work. “This isn’t the first conversation we’ve had of a genetic company being taken over by someone else,” she says.

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