NEW YORK – These are heady days for the UK direct-to-consumer genetic testing market, with multiple entries from a new cadre of companies to serve the continuous need for SARS-CoV-2 testing in light of the ongoing COVID-19 pandemic.
This month, MyHealthChecked launched its own service, which relies on Yourgene Health's Clarigene SARS-CoV-2 PCR test coupled with EKF Diagnostics' PrimeStore MTM sample collection device.
It's the first offering from the firm, formerly known as Concepta, a Cardiff-based personalized health company specialized in fertility testing, since it acquired Manchester-based The Genome Store in November. MyHealthChecked wasted no time in rolling out its COVID-19 service, which tests customers' self-administered nasopharyngeal swabs for the virus and retails at £95 ($115), with a typical turnaround time of 48 hours. Customers can order and receive results online.
CEO Penny McCormick said that MyHealthChecked is focused on integrating Concepta and The Genome Store, as well as on developing a menu of tests that it plans to begin introducing in 2021. Yet given the current health crisis, plus the capabilities it acquired with The Genome Store, including a genomic laboratory, it made sense for the company to go straight to consumers with its offering.
"It would have been remiss of us not to go to market with this test," McCormick said, noting the busy holiday season, when many intend to travel home or visit relatives elsewhere and would like to test themselves using a PCR-based service – viewed as the most reliable type of test in the market – before embarking on those travels.
"We wanted to have a good and robust product that people could use," said McCormick of the service. "We launched that into the market at pace and are seeing a significant level of interest."
The fallout from the COVID-19 pandemic has had interesting repercussions for UK consumer genetic testing firms. The backdrop is tragic – according to the latest World Health Organization statistics, there have been more than 1.7 million confirmed cases in the UK since the pandemic started, along with 62,000 deaths. Yet it has also raised the public awareness of different kinds of tests available and, especially, the ability to take a SARS-CoV-2 test at home, making it easier for companies like MyHealthChecked to educate and reach customers.
"There has been a lot of talk in the media about rapid tests and lateral flow tests, both good and bad," noted McCormick, "and I think people in the main understand there is an accuracy level that isn't right for them and certainly isn't being offered to them by [non-PCR] tests."
Because PCR tests have accuracy of around 99.9 percent, and are used as the primary testing platform by the UK's National Health Service, they are both more widely recognized and trusted by customers, McCormick maintained. "I think people are very familiar with these tests and have either taken them or know someone who has been tested."
Other companies have also been keen to serve the UK market. DnaNudge has launched a new service that relies on sputum samples and pooled testing, enabling the analysis of up to 10 people for £100 ($133) on its real-time PCR platform. LetsGetChecked, a Dublin-based firm, also offers PCR-based testing for £124. The MyHealthChecked test is currently available solely for UK customers. In addition to the test result, the company also supplies a certificate to show to travel companies ahead of flying.
"These flight certificates are very important to people," noted McCormick. "Obviously, customers are investing a lot in holidays and business travel, as well," she said. "This is where we are seeing an awful lot of activity."
Bhavika Patel, a product specialist at MyHealthChecked, who joined the company from The Genome Store, said the firm did its homework when it came to selecting a PCR test for the service. She noted that since the Yourgene Health Clarigene test came onto the market a bit later than some other assays – it was initially launched at the end of June, and obtained a CE-IVD mark in August – it was somewhat better built to "hit key targets with robust internal controls."
Yourgene Health, like The Genome Store, is based in Manchester. "This is a company we know quite well with a test that we know really well," said Patel. "For us, it was a no-brainer to pick this product."
Past and future
Founded in 2013, Concepta has specialized to date in direct-to-consumer tests focused on women's health and unexplained infertility in particular. The company in 2018 launched its lateral flow-based MyLotus test for measuring women's hormones to improve conception, sales of which were buoyed by deals with British pharmacy chain Boots.
The past year has been one of change for the firm. McCormick was named as CEO in November 2019, joining the company after serving as managing director at BBI Healthcare, a consumer healthcare company headquartered in Crumlin, Wales, and MyLotus was rebranded as Mylo last summer. The company has also intensified its efforts to build out a suite of fertility tests. Separately, it concluded a licensing agreement with Abingdon Health that allows Concepta to use the firm's App Dx smartphone reader technology.
"Fertility is still very much of our portfolio and an area that we are extremely passionate about," said McCormick. Yet the company wanted to diversify, too, and provide a wider product menu.
It found that opportunity in The Genome Store, a startup established last year at the Manchester Science Park that has been developing a series of consumer genomics tests for male and female wellness, food intolerance, and lifestyle. McCormick said the know-how of The Genome Store's founders, along with its lab, made it a "great fit" for Concepta. The deal closed on Nov. 23 for £280,000 in shares, with a deferred consideration of up to £240,000 in shares payable upon achieving certain milestones.
As part of the acquisition, Patel joined MyHealthChecked as a product specialist. She is also a member of the firm's scientific board, along with other The Genome Store principals Greg Fitzgibbon, Jane Kelly, and Paul Docherty.
Because the company is no longer focused solely on fertility, it decided to rebrand and began trading under its new name on the AIM market of the London Stock Exchange on Dec. 2.
"MyHealthChecked gives us a good name, for which we can develop tests for the whole family," said McCormick. The company thus far is close-lipped about new products, noting the increasing competitiveness of the UK market. Neither McCormick nor Patel would divulge its planned services for 2021, but affirmed there are various new offerings in the firm's pipeline.
"We have a lot of tests coming, we have a really exciting portfolio, and we are able to be market reactive, because everything is in house," said Patel. "It's our bread and butter, it is what we know how to do best."
Patel added that Concepta's success to date with its fertility tests, along with its management's deep experience in consumer health, encouraged The Genome Store to move ahead with the deal.
"Partnering with Concepta's team, who know how to market these tests and bring them to users in a way they can enjoy the experience, will put science straight into people's hands," she said.