Game On, page-447

Just to recap for those who can't listen at work:

1250 plus patients enrolled, study is complete and results are being analyzed now
Mid to late July the results are expected
Submission to FDA de novo class 2 in August
FDA clearance expected before end of calendar year

This part is interesting:
Pricing model is to charge every time the test is used in consultation, they are looking at around 5 to 10 USD each test. They expect at least "in the 10's of millions" of tests to take place in the states alone.