21st Century Medicine

On the eve of the FDA's public hearing on their draft guidance on in vitro diagnostic multivariate index assays (IVDMIAs) a group comprised of molecular diagnostic companies and investors known as The Coalition for 21st Century Medicine has asked the FDA to follow a more formal process in determining the future of this promising technology. What is being considered here is whether IVDMIAs may be subject to FDA regulation and if so, which ones and how much. Added regulation means added resources, resources that could be spent on further research and development and expansion of technologies that are still very much in a nascent stage. These are the early days of personalized medicine, a time in the life cycle of a technology where a significant investment is required to make headway. The added burden of regulation may present a set back to the industry just when businesses were beginning to show some returns.

Although regulation of IVDMIAs is inevitable, requiring the FDA to go through a more formal process before initiating regulation will buy some time, time to bring more products into the market, gain more credibility with the insurance companies and bring a greater return to investors before the added costs of regulation come into play.

FDA Approves Breast Cancer Test

As I was writing yesterday's blog, the FDA announced the approval of a genetic prognostic test for breast cancer recurrence. The test MammaPrint was developed by the Dutch company Agendia and is the first in vitro diagnostic multivariate index assay (IVDMIA) device to be cleared by the FDA. MammaPrint uses a microarray chip to measure the activity of a set of 70 genes the pattern of which will predict whether the cancer will metastasize. Many women who have their tumors removed undergo chemotherapy on the theory that it will reduce their chances of recurrence. Studies have shown however, that most will not experience recurrence and don't need the chemo. However, it was unclear as to which patients would benefit from chemo and which would not forcing many women to needlessly undergo the treatment and its painful side effects. This test promises to make the decision easier and has shown to be 96.7% accurate.

Genomic Health also markets a genetic breast cancer prognosis test called Oncotype DX. Oncotype DX profiles 21 genes using RT-PCR technology. Both tests run between $3,200 and $3,500 and health insurers and Medicare are initiated coverage of Oncotype DX.

The FDA will hold a public meeting tomorrow to discuss its draft guidance describing its regulatory approach to this type of test.

Regulating Genetic Testing

Although there are around a thousand genetic diagnostic tests available in the U.S., only six are approved by the FDA. So if you want to know if you have a gene for susceptibility to a bacteria living in hot-tubs you can submit your genetic material to any one of a number of labs and have them run a test. Of course there's no guarantee of the results, either that the genes tested for are markers to indicate susceptibility or the algorithms matching the expression profiles to susceptibility are correct. Even after testing negative for the genes you may still get the dreaded hot-tub bug. For this reason, the FDA has recently announced that it will begin the public comment period regarding genetic tests. David Ewing Duncan has written an article in Technology Review on this impending arrival of personalized medicine.