User 166143

Nanosphere Will be a Big Winner

"Using nanotechnology also enables the testing to be 100X more sensitive than older technologies enabling earlier detection and the discovery of new biomarkers."

Really?

NOPE!

Funny thing is that the NSPH teschnology is 40-times LESS SENSITIVE than earlier detection methods like PCR!

There are two warfarin genotyping tests that are FDA cleared, one from NSPH and the other from Autogenomics (using PCR). The Autogenomics test is 40-times more sensitive than the NSPH test.

www.fda.gov/cdrh/pdf7/...
www.fda.gov/cdrh/pdf7/...

Did you actually do ANY research at all to verify the veracity of anything you wrote?

Nanosphere Will be a Big Winner

"Right now, Luminex is the only other company that has a test for CF."

Really? NOPE!

Abbott/Celera has one.
www.accessdata.fda.gov......

Clinical Microsensors has one.
www.accessdata.fda.gov......

Third Wave has one.
www.reuters.com/articl......


"Also, the company is targeting approval of a Respiratory Virus Panel test that can diagnose the flu ready for the 2009 flu season."

Too bad that Luminex and Prodesse have already beaten them to market with respiratory virus panels! And Eragen is submitting one to the FDA this year!

www.accessdata.fda.gov......
www.accessdata.fda.gov......

"The company also hopes to have a test for HPV virus available in 2009"

Really? Funny thing is that HPV tests require a PMA submission with clinical trials that last years in support of the PMA submission! And there is already an FDA-approved HPV tests, plus Roche already has two HPV tests that were submitted tot he FDA last year, and TWTI has two being submitted next month!


"The current troponin tests have to be sent to a lab and sometimes do not get a result for up to 10 hours."

Really? NOPE!

"On average, they reported 90% of myocardial injury marker results in slightly more than 90 minutes measured from the time that those tests were ordered. Among the fastest performing 25% of participants (75th percentile and above), median order-to-report troponin and creatine kinase-MB TATs were equal to 50 and 48.3 minutes or less, respectively. Shorter troponin TATs were associated with performing cardiac marker studies in EDs or other peripheral laboratories compared to (1) performing tests in central hospital laboratories, and (2) having cardiac marker specimens obtained by laboratory rather than by nonlaboratory personnel"

findarticles.com/p/art......