Great article with some good insights. A few statements that caught my attention.
“sale of clinical instrumentation to the United States Food and Drug Administration (FDA).”
The FDA isn’t just buying the test they are buying the machine to allow their scientists to examine it and verify its reliability.
“Arrayit CEO Rene Schena states, “The sale of clinical instrumentation to the FDA advances our personalized medicine initiatives by strengthening ties with the nation’s preeminent regulatory agency. Our transformative healthcare products and services benefit from transparency in the hands of top FDA scientists.””
They key word is transparency with FDA scientists. It’s one thing to see results from a test, it’s another to examine the machine that produced those results. This is perhaps the biggest and most exciting aspect. The second statement that’s key is our products (plural) and services benefit from the transparency with FDA scientists. This dispels the fraud issue with other companies.
Avant recently received Institutional Review Board (IRB) approval from the United States Food and Drug Administration (FDA) to validate ovarian cancer specimens pursuant to 510(k) approval of OvaDx(R), a pre-symptomatic ovarian cancer test that aids the monitoring of women diagnosed with ovarian cancer. OvaDx(R) is exclusively manufactured by Arrayit and will be marketed and sold by Avant upon FDA approval.
This leads me to believe that the FDA approval we are waiting for is going to be for the machine, in addition to the Ovarian cancer test and the food allergy test. I think the Parkinson’s test will come later. Once they the approval for the machine, the approval for the test will come quickly.
The company is going the extra mile to build a relationship with the FDA and lay all their cards on the table. No way in the world you do this unless you are 100% confident of the results. Plus it’s a great selling point to future clients.
Just my humble thoughts. Look forward to reading your assessment of the article and statements from the CEO.
