Recently, Celera Corporation (CRA) submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its KIF6 test, which detects a variant in a gene called KIF6. Data from various researches have shown that approximately 60% of the studied population has this gene variant and individuals with the KIF6 variant have a 55% higher risk of having a cardiovascular event, such as a heart attack. Moreover, studies have revealed that this higher cardiovascular risk can be substantially and significantly reduced with the help of statin therapy.

Celera has an agreement with Abbott Laboratories (ABT) to distribute the KIF6 test in Europe. Earlier, in June 2010, the KIF6 test received CE mark approval. The company is seeking regulatory approval in the US for  running the KIF6 test on Abbot's m2000 instrument. Successful commercialization of the test in the US should enable Celera to record higher revenues.

Revenues from lab services have been the biggest contributor to Celera's top line, constituting about 64%. However, during the third quarter of fiscal 2010, revenues derived from this segment declined 15.7% year over year to reach $20.4 million due to lower sample volume, partially offset by higher average price per sample with physicians ordering for new higher value genetic tests. Sample volumes declined approximately 22% driven by competitive pressures as well as the loss of business from accounts serviced by former BHL sales representatives. Moreover, Celera also witnessed reduced healthcare spending as patients were making fewer physician visits resulting in lower volume of laboratory testing.