Two Major Reference Labs Sign With Critical Diagnostics


SAN DIEGO--Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases and Quest Diagnostics (NYSE: DGX) and its subsidiary Berkeley HeartLab, announced today an agreement under which both Quest and Berkeley HeartLab will offer ST2 testing services based on Critical Diagnostics' Presage ST2 Assay. Critical Diagnostics has also signed an agreement with Laboratory Corporation of America (NYSE: LH), better known as LabCorp, to offer testing of the Presage ST2 Assay. Combined, these two diagnostic market leaders perform some one-and-a-half million tests per day.

The Presage ST2 Assay is FDA cleared for use in assessing the prognosis of patients diagnosed with chronic heart failure. According to the American Heart Association, heart failure affects some 6 million Americans with 600,000 new diagnoses each year.

Clinical studies have demonstrated that high levels of soluble ST2 are predictive of adverse patient outcomes and death. For instance, chronic heart failure patients with ST2 levels above the standard cutpoint, have a three times greater risk of 30-day rehospitalization or mortality.

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 and, if needed, to quickly adjust care.

Furthermore, prognostic information from soluble ST2 is independent of and complimentary to natriuretic peptide markers like BNP and NT-proBNP, and unlike natriuretic peptide markers, is not adversely affected by such confounding factors as age, gender, body mass index and impaired renal failure.

"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."

About Critical Diagnostics and ST2

Critical Diagnostics ( develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. The Presage ST2 Assay has been CE Marked and cleared by the US FDA.

About Quest Diagnostics and Berkeley HeartLab

Quest Diagnostics is the world's leading provider of diagnostic testing, offering the broadest access to diagnostic testing services through its network of laboratories and patient service centers. Berkeley HeartLab is the company's business unit specializing in advanced cardiovascular disease testing.

About LabCorp

LabCorp, with corporate headquarters in Burlington, NC, and more than 30,000 employees nationwide, has some 220,000 clients including physician offices, hospitals, managed care organizations, and biotechnology and pharmaceutical companies.