Critical Diagnostics has locked down agreements with Quest Diagnostics ($DGX) and LabCorp ($LH), placing its heart failure assay in the hands of two industry giants that perform a combined 1.5 million tests per day.
Under the deal, LabCorp and Quest--through its Berkeley HeartLab--will each distribute and administer Presage ST2, a molecular diagnostic FDA-cleared for use in assessing the prognosis of patients diagnosed with chronic heart failure. Critical's test detects ST2 gene expression, charting the biomarker to predict adverse events in cardiac patients.
Placing the test with the two market leaders is a coup for Critical Diagnostics, 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.
Critical is continuing to expand Presage's reach, signing deals in October with four distributors in Europe, a move that will get the assay on shelves in Germany, Spain, France and Turkey. Over the summer, the company signed on two distributors in Asia, giving its test a foothold in 17 countries on the continent.
- read Critical Diagnostics' announcement