Pathway Genomics Launches and a Look Back at Two Years of DTC Genomics

Winding Road 75Pathway Genomics became the latest entrant in the consumer genomics space when it publicly launched its new direct-to-consumer (DTC) genotyping service this morning. Pathway provides genotyping (or SNP testing) for a variety of genetic traits and markers including ancestral testing for $199, health and disease testing for $249 and both the health and ancestry service for $349, which is a $50 price drop over the current market leader, 23andMe. Blaine Bettinger (of the Genetic Genealogist and a consultant for Pathway) previewed the service back in March and today’s Bio-IT World also has a detailed summary.

What’s new about Pathway Genomics? From a narrow perspective, perhaps not much. On its surface, the Pathway offering is comparable to products already on the market from 23andMe, deCODEme and Navigenics. Although it’s too early to evaluate Pathway’s promises of “better science, deeper results, and a better price,” the genotyping service appears competitive with existing industry offerings, with the ancestry testing component positioned to be an industry leader. However, unlike the last major DTC genomics announcement, there does not appear to be anything fundamentally new about Pathway’s technology or market-shattering about its price point.

Even though Pathway does not appear to offer a breakthrough technology or business model, its launch is still a significant event. It represents yet another bet by investors on the commercial potential of consumer genomics and ratchets up the competition for DTC market share. Moreover, Pathway’s service is indicative of how the consumer genomics industry continues to shift.

When the DTC genomics market first began picking up steam late in late 2007 and early 2008, deCODEme, 23andMe and Navigenics quickly emerged as industry leaders, positioning themselves not as providers of clinical or medical diagnostic services but as personal genetic information services, emphasizing their educational, recreational and lifestyle features. In 2008, as regulators in New York and California questioned whether DTC companies were inappropriately offering clinical genetic testing, industry leaders continued to maintain that they were not offering clinical services and that their products were educational, not medical.

The last twelve months, however, have seen a marked shift in tone. In August 2008, as California began to license DTC genomic service providers, the nature and scope of DTC services began to shift, expanding to include more distinctively clinical features including genetic carrier screening and medical research. Meanwhile, the companies themselves have been collaborating with state and Federal regulators to design a regulatory framework that offers appropriate consumer protections without restricting users’ access to their genomic data or stifling the growth of the DTC genomics industry.

It may appear that Pathway is late to the party, but the company appears to have been paying close attention to the space. Although the company is headquartered in California, where regulators and legislators have been more publicly attentive to DTC genomics companies than perhaps anywhere else in the world, Pathway’s CEO James Plante does not sound overly concerned:

Awareness [of DTC genomics] is increasing, some of the regulatory and other issues have been discussed and there’s pretty good understanding of how companies in this space need to act responsibly and what consumers are interested in.

Although Plante is correct that many of the regulatory issues surrounding the DTC genomics space have been “discussed,” few if any have been resolved. But by using separate customized chips which enables it to offer ancestry testing independently from health and medical genotyping, Pathway’s launch reflects a new wrinkle in how the industry may attempt to respond to the anticipated regulation of clinical genetic testing. Differentiating its recreational and clinical products from the outset could be just the sort of subtle but significant decision that would allow Pathway to quickly adapt to any regulations that distinguish educational or recreational uses of genetic data (such as genealogy) from clinical or medical uses (such as disease, pharmacogenetics or carrier testing).

Whether or not it proves possible to maintain a recreational/clinical distinction from either a scientific or a regulatory point of view remains to be seen, but Pathway appears to be doing what it can to provide itself with the flexibility it will need to navigate a complicated and rapidly evolving DTC genomics landscape in the coming months and years.