Genentech (DNA) recently filed a Citizen Petition with the FDA attempting to persuade the agency to use a monocle for ALL diagnostic tests, with particular attention paid to Laboratory Developed Tests which are designed to guide therapeutic decisions.
"According to Genentech, pharmacogenomic information is contained on the label of around 10 percent of all FDA-approved drugs." -- Genomeweb
This is a surprisingly high number if it's true but even if it is not the percentage is sure to grow as we learn more about human genetic variation.
Interestingly, DNA received nearly instantaneous support from Kathy Hudson at the Center for Genetics and Public Policy. She is clearly developing an integral position as an informed player in this and other ongoing debates. However, as a policy group, it seemed odd to provide such quick, unconditional and one-sided support to a single, large, publicly-traded company without a counterbalancing perspective on behalf of all the small and mid-sized laboratories doing innovative work in this nascent field. Particularly because a fair amount of the innovation in the field falls within the LDT silo.
If the current 15 year, heavily-regulated drug development process is any indication of the success and expediency of the FDA's regulatory authority, I think we're in for a bumpy ride and significant delays in diagnosis of genetic diseases. That can't be good for patients. On the flip side, I think we can all appreciate the need for standardization and an "apples to apples" approach to diagnostics in medical practice. So how should we think about this public move by a public company?
Well...what does Genentech stand to gain? OR more importantly, what do Combimatrix, Monogram, Clinical Data, Genomic Health, Response and others practicing non-DNA approved LDT tests stand to lose?
Genentech's soon to be parent, Roche Holding AG, may be providing the motivation. Roche's hostile $3 billion cash offer for Ventana Medical Systems Inc. last year underlines the Swiss health-care company's strategy of acquiring midsized and small companies whose diagnostic products allow it to target drugs to individual patients. Roche also acquired NimbleGen, a maker of high-density DNA microarrays, tools used in pharma research to understand the genetic causes of disease and the identification of potential drug targets. In April of last year, Roche agreed to buy BioVeris Corp., a U.S. diagnostics company, for $600 million and also recently bought 454 Life Sciences Corp. a maker of sequencing products for diagnostic tests.
It appears Roche/Genentech are trying to use this broad public appeal to protect their investment and break the back of small companies with revenues from LDTs. In this pernicious fundraising environment they will likely not survive regulation. Read: the losers may be the cash-starved start-up companies providing high-quality LDTs and surviving/developing new tests via those early testing revenues.
I think its safe to assume that any FDA regulation at this point will slow progress, limit/delay disease diagnosis, stymie small business innovation, etc. Is that a good thing? Is NOW the right time for this legislation to be enabled/enacted? Or should we let things mature a bit more?
If you need evidence that the FDA process will delay new commercial products without taking all the risk out of the end product just think (Vioxx, Celebrex, Fen-Phen, etc) and see the graphic at the right...