Even with Caveats, FDA Approval of BRCA Test Boosts $99M Direct-to-Consumer Testing Market

Press Release
Mar 6, 2018
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Rockville (MD), March 6, 2018 — 23andMe, Inc., the Mountain View, CA-based personal genetics company, announced today that it had received the first-ever FDA authorization for a direct-to-consumer genetic test for cancer risk. Healthcare economics and market research firm Kalorama Information, who estimated the market for direct-to-consumer genetic health tests at $99 million, finds this development a sign of growth of a market for and popularity of genetic tests. The firm’s latest report, Direct to Consumer Genetic Health Testing, used interviews, annual report findings and economic data to make its analysis, and factored likely future approvals in its analysis.

Kalorama says the DTC genetic health market will grow to $310 million in 2022.

"If we see this as the healthcare system's natural and justifiable concern over costs and outcomes, versus the patient's drive to know, patient knowledge will prevail long-term," said Bruce Carlson, Publisher of Kalorama Information. "However, we should all note that the approval comes with warnings that uphold the primary role of doctor-driven traditional cancer diagnostics."

The authorization allows 23andMe to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer.

The FDA cited a need for greater cancer detection as a key reason for approval.

"This test provides information to certain individuals who may be at increased breast, ovarian, or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of DTC genetic tests,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health within FDA's Center for Devices and Radiological Health.

The department is the key regulator of IVD tests. The agency did also state its concern that tests are not the be-all and end-all of detecting cancer risk.

“But it has a lot of caveats,” St. Pierre said. “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual's risk are not detected by this test. The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk."

Several trends are continuing to shape the direct to consumer laboratory testing market including the growing demand for early disease detection and diagnosis, personalized medicine, importance of disease monitoring and expanded technologies.

There has been a shift in healthcare utilization primarily due to reducing healthcare spending which makes the laboratory an even more valuable part of the treatment plan. With the increased use of the Internet for medical information, consumers have become medical consumers not just patients. This has created a change in the doctor/patient relationship as individuals become more knowledgeable about their own health and want more control over their personal information and treatment decisions. Consumers are more cost-conscious and the increase in high deductible insurance plans requires that individuals ask more questions, do their own research and collaborate with their doctor about medical decisions, tests, and treatments.

Kalorama reports looks at up and coming companies in the market. There are several players though the market mover of note is 23andMe. The report also looks at both the direct-to-consumer and consumer initiated, physician coordinated test products as well. The report can be found at: https://www.kaloramainformation.com/Direct-Consumer-Genetic-Health-Testing-11370673/.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama’s website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.

Please link any media or news references to our reports or data to https://www.kaloramainformation.com/.

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