Peter,
I don't think the FDA website mentions products until they are approved, the product is the eSensor Cystic Fibrosis test and was submitted to the FDA for approval earlier this year. The Company first mentioned the approval process in their Trading statement in November,
"The eSensor Cystic Fibrosis test is currently being reviewed by the FDA and
based upon the strong test data and other supporting information we anticipate
receiving approval either late this year or early next year."
It is due at any time, hence the share price action here.