Genetic Tests: Two Companies Different Stories

In the last 4 weeks, two things happened in the genetic diagnostic kits. The genetic diagnostic kit developed by 23 and Me got approval from FDA, albeit for a much more specific area than the company wanted. And Pathway Genomics got a letter from FDA asking to stop selling its cancer genetic diagnostic kit. This story is an interesting case study of two companies developing identical technologies but drastically different regulatory strategies. About 5 years ago, in 2010, Pathway Genomics created an earthquake of sorts in the genetic diagnostic industry when it made a deal with Walgreens to mass market its genetic diagnostic kits leading to FDA inquiring and subsequent Warning Letters to several genetic diagnostic companies to cease and desist marketing of unapproved genetic tests. It seems Pathway did not learn anything from its experience and is still trying to market genetic tests over FDA’s objection citing Laboratory Developed Test (LDT) pathway. On the other hand, 23 and Me, took a much more measured approach of taking FDA’s criticism in 2013 seriously, developing a robust regulatory strategy to seek FDA approval and finally getting FDA approval 2 years later, this week. FDA has long claimed that LDT does not apply to mass marketed products. It also recently announced conditions under which a diagnostic test would meet LDT conditions or not. The fact that despite having 5 years to prepare Pathway Genomics is still pretty much where is started, seems to indicate either they have bad data to support their product or simply bad regulatory strategy. Either way, it does not seem FDA is planning to let this case slip by.