Recently, Celera Corporation (CRA) has signed a four-year distribution agreement with Abbott Laboratories (ABT) to market Celera’s KIF6 diagnostic test in Abbott’s m2000 instrument. The KIF6 test is aimed at identifying an individual’s risk of coronary heart disease (CHD) and response to statin therapy. Earlier, in June 2010, Celera received CE Mark approval for its real-time PCR (polymerase chain reaction) test to detect a variant in the KIF6 gene.
 
While Celera will manufacture the KIF6 test kits, Abbott will be responsible for its distribution in Europe and other regions recognizing the CE Mark. However, financial terms of the deal were not disclosed. We believe immense potential lies in the detection of CHD as it has been observed that a variant of the KIF6 gene is related to about 55% increased risk of the event, which was significantly reduced with statin therapy.
 
The relationship with Abbott is not new for Celera. Since 2008, the two companies have had a distribution and royalty agreement. Abbott’s m2000 system offers a wide portfolio of tests outside the US which includes tests for HIV, hepatitis B and C viral load, hepatitis genotyping, colorectal cancer among others. While tests including HIV, HBV are approved in the US, Celera’s KIF6 represents the first cardiovascular test.
 
During the second quarter of fiscal 2010, Celera added new tests to its cardiovascular testing portfolio with the launch of a Cytochrome 2C19 (CYP2C19) genetic test to assess an individual’s response to Plavix (anti-clotting drug).  With respect to the approval of the KIF6 test in the US, the company plans to submit a Pre-market Approval (PMA) later in 2010.  Celera aims at making the KIF6 testing widely available and converting the genetic discoveries into routine personalized care for patients with high risk of cardiovascular disease.
 
We have a Neutral recommendation on the stock.
 
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