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Two labs sign with Critical Diagnostics

San Diego-based Critical Diagnostics announced Thursday an agreement with Quest Diagnostics (NYSE: DGX) and Berkeley HeartLab under which both Quest and Berkeley will offer ST2 testing services based on Critical Diagnostics’ Presage ST2 Assay.

Also announced was Critical Diagnostics' separate agreement with Laboratory Corporation of America (NYSE: LH), better known as LabCorp, to offer testing of the Presage ST2 Assay.

Critical Diagnostics, a biomarker company focused on cardiovascular diseases, combines with LabCorp to perform some 1.5 million tests per day, according to a release from Critical Diagnostics.

The Presage ST2 Assay is an FDA-approved assessment for the prognosis of patients diagnosed with chronic heart failure.

Unlike many other cardiac biomarkers, ST2 levels change quickly in response to changes in the patient’s condition — thus helping physicians make informed decisions on an appropriate course of action to take. The American Heart Association reports that heart failure affects around 6 million Americans per year, with roughly 600,000 new diagnoses annually.

Clinical studies have demonstrated that high levels of soluble ST2 are predictive of adverse patient outcomes and death.

“We are extremely proud to be associated with these two exceptional organizations,” said James Snider, president of Critical Diagnostics. “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.”

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