>>I think the nearness of their direct competitors is a bit overstated.<<
Letter to Correlogic from the Office of In Vitro Diagnostic Device Evaluation and Safety:
fda.gov
Meaning that everyone in this space is going to have to do trials and submit a PMA. Their president's response:
correlogic.com
I doubt that the FDA is going to sanction that kind of dodge. If it were going to do so, Roche and Affymetrix would have the AmpliChip on the clinical market by now.
Current state of their validation trials; it's going to be a couple of years:
correlogic.com
Snip from CIPH's most recent quarterly PR:
>>Ovarian Cancer Initiative. Ciphergen's 500 sample, multi-site ovarian
cancer study, conducted in collaboration with the Johns Hopkins
University School of Medicine, MD Anderson, Duke University Medical
School, The Royal Hospital for Women (Sydney), University Hospital
Groningen and Queen Mary's School of Medicine (London) has been
accepted for publication by the journal Cancer Research, with
publication expected in the next few months. Our follow-on study,
employing 1,500 samples from two additional sites, is currently being
conducted around three clinical questions: early detection, late stage
detection and treatment monitoring for recurrence.<<
Seems to me CIPH is at least a year ahead in assembling a PMA package.
Cheers, Tuck |
