Critical Diagnostics signs on with Quest, LabCorp

Critical Diagnostics has found success with its assay for chronic heart failure, using a genetic biomarker to predict adverse events in cardiac patients. Now, the company has locked down placements with Quest Diagnostics ($DGX) and LabCorp ($LH), the two largest testing outfits in the world.

Under the deal, the two diagnostics companies will distribute and administer Presage ST2, an FDA-cleared molecular test that charts expression of the ST2 gene to assess the prognosis of patients diagnosed with chronic heart failure. Combined, Quest and LabCorp conduct about 1.5 million tests per day, and the deals create a considerable opportunity for Critical and its lead product, President James Snider said.

"The Quest/Berkeley HeartLab and LabCorp collaborations, in addition to our existing clinical lab relationships, mean that physicians nationwide will now have access to Presage ST2 testing to help guide and improve heart failure patient outcomes," Snider said in a statement.

Unlike other cardiac biomarkers, ST2 levels react quickly to changes in a patient's condition, making the gene's expression an ideal tool for rapid prediction of patient outcomes and allowing physicians to adjust care before adverse events take place, Critical said. Furthermore, ST2 readings are independent of other markers and aren't affected by confounding factors like age, gender, body mass index and impaired renal failure, according to the company.

The two placements are the latest coups in Critical's effort to get Presage ST2 in as many labs as possible. In October, the company inked deals with four distributors in Europe, giving it market access in Germany, Spain, France and Turkey. Before that, Critical signed on with two Asian distributors, placing the test in 17 countries around that continent.

- read the announcement