October 11, 2021
When the U.S. Food and Drug Administration approved marketing of direct-to-consumer (DTC) genetic testing in the early 2000s, it allowed individuals to learn about genealogy, inherited traits, health predispositions, and much more without involving a physician. It also created a market that, while not nearly as vast as clinical DNA testing, is nonetheless a growing one.
Illustrating this demand, pet owners with a lovable mutt can find out which breeds produced their furry friend by way of at-home DNA test kits. For the cannabis enthusiast, Endocanna Health produces a DNA test that the privately held company claims can identify the ideal cannabis dose and formulations for a customer’s specific needs based on their genomics.
These at-home kits typically involve providing a saliva sample and sending it back to the company for analysis, with the results accessible via a secure online portal or a downloadable app. MarketInsightsReports, a leading global market research firm, projects the global direct-to-consumer genetic testing market to grow at a compound annual growth rate of 18.9% during 2021-2027. The players in this space range from small privately held startups to large publicly traded corporations, all of whom are vying for a piece of this rapidly growing market. Let’s take a look at some.
23andMe Holding Co. (Tii:ME) Co-founder CEO Anne Wojcicki told Yahoo Finance that she “absolutely” anticipates a future in which everyone receives DNA sequencing at the outset of their lives. Whether that comes to pass remains to be seen, 23andMe currently boasts a database of almost 12 million genotyped customers. Alongside rival Ancestry.com (which private equity giant Blackstone Group acquired in 2020 for $4.7 billion), 23andMe is likely the best-known provider of DNA test kits with consumers. The company, which went public in August via a merger with Richard Branson’s SPAC, VG Acquisition Corp., generated 23% higher fiscal first-quarter revenues on increased delivery of its Personal Genome Service kits to customers.
With a stated mission of bringing genetics to mainstream medicine to improve healthcare, San Francisco-based Invitae Corp. (Tii:NVTA) offers test kits that assess risks for developing cancer, cardiovascular disease or whether an individual is a carrier of a genetic disorder that could be passed to a child. Tests come with next steps and access to Invitae’s genetic counselors. The company announced last month that it plans to acquire Ciitizen, a patient-centric consumer health tech company, for approximately $325 million. Ciitizen is developing a global platform to help patients collect, organize, store and share their medical records digitally. The acquisition would provide Invitae’s customers with a centralized hub for their genomic and clinical information.
Now in its 20th year as a publicly traded company, Exact Sciences (Tii:EXAS) is a leading provider of cancer screening and diagnostic tests. It is also the company behind Cologuard, an at-home colorectal cancer test kit that analyzes both DNA alterations and blood in the stool to detect the presence of colon cancer and pre-cancers. The company, whose second-quarter sales increased 62% compared with the year-ago period, also experienced a bump in its share price last month after announcing an expansion of its primary care sales team with the addition of former Pfizer sales representatives.
OraSure Technologies (Tii:OSUR) develops and manufactures rapid diagnostic tests that include DNA and RNA collection kits. OraSure’s OMNIgene ORAL saliva collection device received authorization from Health Canada for use as a component in molecular diagnostic tests for the detection of SARS-CoV-2. The company also received a $109 million contract from the U.S. Department of Defense to build additional manufacturing capacity in the United States for its InteliSwab COVID-19 rapid tests as part of the nation’s pandemic preparedness plan. The FDA previously approved InteliSwab for professional point-of-care use, prescription home use, and over-the-counter use.
Increased consumer interest in health and wellness bodes well for companies in the at-home genome testing market – though some of the smaller players may end up as acquisition targets. That said, despite privacy concerns over submitting DNA to corporations, technological advances providing greater health information for consumers should ensure continued demand for at-home genomics testing.