7. In the real world all samples are included. LIE - failures are rarely reported in pilot trials
8. SQNM's RNA test needs FDA approval. LIE - almost 40% of CLIA labs do not use FDA approved tests at all, and another 26% use them for less than 25% of the tests they offer. Per FDA guidelines SQNM's RNA test is not an IVDMIA and is excluded from FDA oversight.
9. SEQureDX will never be accepted by the medical community due to "no-calls". LIE - Physicians will evaluate the utility of SEQureDX compared to the current regimen for prenatal Downs screening which is a series of tests over several weeks. The number of no-calls (5%-7% in the real world) will have negligible bearing on their decision when the obvious advantages of accuracy, timeliness and cost are so clear.
In the event of a no-call, when a patient's only loss is a tube of blood and the loss of time it takes to draw the blood, versus the 95% chance that there will be a definitive answer to the health of their baby, Physicians and mothers will take that chance.