Yes, it is true that SQNM can launch their test without submitting it to the FDA, BUT it is widely expected that the FDA eventually will assert its regulatory authority in the face of rapidly proliferating CLIA generated tests.
Over 100K women each year have amnios or CVS because of false positives by current Downs screening. The current gold standard for Downs screening, the Quad Test, is only 4% accurate. In SQNM's latest study, of the 858 women who had to undergo amnio only 28 were actually carrying a Downs baby. If SQNM's test was available, 830 women would NOT have had to undergo surgery.
How's that for accuracy? Why aren't you raising a stink about a test that annually puts over 100K babies at risk unneccessarily?
SEQureDX will DECREASE SUBSTANTIALLY the number of unnecessary surgeries - by over 90%. If the FDA is that concerned, approval for SEQureDX will be a SLAM DUNK!!!
>>>The FDA was concerned about the test because it could lead to unnecessary surgery from a false positive.
The FDA does NOT want the general public using screening tests that could cause harm from incorrect results. <<<
Are you aware that Genentech petitioned the FDA in December to assert its regulatory authority over CLIA lab diagnostic tests? Are you aware that for the last couple of years the FDA has been preparing to do just that?