http://www.nytimes.com/2013/05/08/business/prostate-cancer-test-from-genomic-health-assesses-risks.html?smid=tw-share&_r=2& was this test or any of their tests, vetted by the FDA? smells like a scam to take advantage of vulnerable cancer patients.
No it wasn't. But there are a number of clinically useful tests that didn't go the FDA route (Oncotype Dx, or Sequenom's MaterniT21 test for example). Payers don't give a hoot about FDA approval, as that approval doesn't mean the test is of any worth in a patient's treatment. Instead, the payers will look to studies that show a test passes thresholds of analytical validity, clinical validity, and clinical utility.... So - let's wait to see what those studies say, and not expect some useless FDA approval to point the way...
Previous poster is somewhat right. I would add these types of test are not over seen by the FDA and don't require FDA approval.
ever heard of companion diagnostics?? the FDA has been approving drugs along with their companion diagnostic test for over a year...FDA oversight is coming soon for all molecular/genetic testing and ODx will have a tough time proving their marketing claims!
Take a look at the cost? not covered by insurance and if it does get covered by say Medicare, and an older person on a fixed income has to come up with the 20%.....Good luck!! Also, isn't this a PCR-test?
Correction: us insurance companies are looking for ways not to pay for UNPROVEN TESTS! FDA approval has little to no influence on our coverage decisions (just read any Plan's medical policies if you don't believe me). Instead, we hang our hat on peer reviewed, published studies demonstrating clinical validity & clinical utility. You got that, you got coverage for your test, dude!
why do some people post here if they do not work in the lab biz (or are sooooo uninformed) LOL @ FDA approved tests........most of those were done by the probe/kit companies so it would make it harder for competitors to compete. crizotinib is FDA approved but docs running non-FDA approved tests to make treatment decisions as well as most other "companion diagnostics". Altho FDA has been saying they do not approve of non FDA companion DX, too bad NCCN does.
Hear, hear! Apparently, some folks here haven't a clue that some of the most impactful testing over the past 4 years (Oncotype Dx, BRCA, Lynch Syndrome) has never been touched by the FDA. They're called lab-developed tests ("LDT's"), and the FDA doesn't have any regulatory authority over them (yet)....
FDA is never going to happen for this test...and you're crazy if you think it won't be required in the near future. You say in your own quarterly prospectus that you would be basically screwed if the fda ever required approval. You're data is shit, oversampled data sets, overlapping CI, and more...and TAYLORX is not going to give you what you want, it's only going to hurt. Agendia's MINDACT and ISPY data is going to put you guys out of business.
You were doing OK until you threw in Agendia...........I work for neither, sell both FDA approved and LDT's.........over priced tests with limited study facts are indeed a challenge to sell. I wish I thought the FDA felt inclined to have no issue with ROS1/ALK as to uncover the 1-2% who will benefit, but I assume they prefer the 98% who will not be treated by a high priced therapeutic. Let them try and mess with HER2 - not with that survivorship/lobby.
