Offering genetic testing direct to consumers is big business, with both 23andMe and Ancestry.com doing very well for themselves as a result. Offering ancestry genetic tests direct to the consumer is one thing, but offering genetic testing for health reasons is an entirely different animal. A few years ago, 23andMe had to suspend all health related tests by order of the FDA on the basis that consumers could make adverse decisions based on the results of these tests. One company that seems to have circumvented the FDA’s concerns about offering genetic health related tests is Pathway Genomics.
Founded in 2008, Pathway Genomics has taken in an undisclosed amount of funding from Peter Thiel’s Founders Fund, Edelson Technology Partners, and the IBM Watson Group. Those who have been accusing Theranos lately of having a politically motivated Board should take a look at Pathway’s Board. Members include a former U.S Secretary of Commerce, a former Chairman of the Joint Chiefs of Staff, a former Administrator of the U.S. Small Business Administration, and even Newt Gingrich. The types of tests offered by Pathway Genomics fall into three broad categories.
DNA Insight™ Genetic Tests
Tests under this category are meant to provide you with insights into how you can live a healthier life. You can find out how well you are expected to tolerate certain medications, how exposed you are to certain genetic diseases, how to manage post-partum weight loss, etc. One of these tests called PathwayFit analyzes 75 genetic markers which tell you how to live a healthier life. The 59 page sample report reads something like a horoscope with such gems as “eat a diet in low carbohydrates” and “you might not like the taste of broccoli”. While the sample report contains extensive information, it’s not that compelling at a $599 price point. PathwayFit can be ordered directly from Pathway Genomics by the consumer, but other tests under this category require a consultation from a Pathway Genomics physician before ordering.
True™ Hereditary Cancer Tests
This test suite contains tests which look at 7 high risk breast cancer genes, 14 colorectal cancer genes, and also specifics genes for Jewish people (3 mutations) and Mexican/Hispanic people (8 mutations). An additional test analyzes the BRCA1 and BRCA2 cancer genes, a feature that 23andMe offered before the FDA halted their test. While 23andMe no longer provides new consumers with genetic interpretations that relate to health, Pathway Genomics may have appeased the FDA by requiring the customer’s physician to request the test.
Liquid Biopsy Tests
This test works by detecting the presence of 96 specific genomic markers called circulating tumor DNA. Two tests have been developed under this offering; one for people with high cancer risk and the other for people with cancer already. For those who are taking the test without having been diagnosed with cancer, examples of high cancer risk include:
These risk factors seem rather broad. Does anyone who had a relative die from cancer qualify as having a “family history of cancer”? Does smoking a few packs back in college count as “history of smoking”? The idea here seems to be that by having your physician order the test, they can assess whether or not you are “high risk” enough to merit taking the test. But even then, when the test tells you that you’re genetically disposed to a particular type of cancer, what do you plan to do about it? The FDA seems particularly concerned about people who look to “preventative surgical procedures” in response to negative results for these types of tests. Interesting enough, in this letter, the FDA sent Pathway Genomics last month, they expressed concern that the test product was being offered directly to the consumer.
From an investors perspective, the “insight” tests are as good as the number being sold. If the consumer finds it valuable to be told that they’re more likely to snack during the day than other people, and they’re willing to pay for that information, then that’s great. On the other hand, the “cancer detection” tests seem subject to the opinion of your doctor. Does he or she really want you to take a test that might cause you unnecessary concern? For people with cancer, do the physicians believe that this test really adds value to your treatment? As for the “liquid biopsy” tests, they now seem at risk following the FDA inquiry. Any company hoping to play in this space will be watching for the outcome with bated breath.
With only an early stage funding round and a great deal of uncertainty surrounding the FDA inquiry, we probably won’t see an IPO from Pathway Genomics anytime soon, especially since the IPO market seems to have gone cold lately.
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