News | Blood Testing | March 22, 2016

Critical Diagnostics Inks Exclusive Worldwide License Agreement for New Heart Failure Biomarker

Company expands cardiovascular biomarker portfolio to address its growing complementary cardiac diagnostics business

March 22, 2016 — Critical Diagnostics announced that it entered into a license agreement for the exclusive worldwide rights to the use of the biomarker soluble neprilysin (sNEP) in the diagnosis and monitoring of heart failure patients. Health Sciences Research Institute Germans Trias i Pujol Foundation (IGTP) of Barcelona Spain is the licensor.

The neprilysin inhibitor Sacubitril is a key ingredient in a new heart failure drug, Entrest,o marketed by Novartis. Entresto is U.S. Food and Drug Administration (FDA)-approved in the United States and EC approved in Europe.

Cardiac biomarkers allow physicians an opportunity to combine clinical observations with objectively measured sub-clinical information in making treatment decisions. In the case of heart failure, the most commonly used biomarkers are the natriuretic peptide biomarkers, BNP and NT-proBNP. However, because BNP is a substrate for neprilysin, levels of BNP will reflect the action of the drug and rise during treatment. Levels of NT-proBNP, on the other hand, will reflect the effects of the drug on the heart and typically decrease during treatment.

sNEP, by contrast, is unaffected by this neprilysin substrate phenomenon, or, for that matter, other common confounding factors that typically affect natriuretic peptide biomarkers, such as age, body mass index and renal function.

“While Entresto brings hope of longer and better life with fewer hospitalizations for millions of people with chronic heart failure,” noted James Snider, president of Critical Diagnostics, “it costs $12.50 a day, or about $4,560 a year, for the two-pill-a-day regimen, versus pennies for generics. We believe use of the biomarker sNEP can play a vital role in determining therapeutic effectiveness of Entresto, thus improving patient outcomes while helping contain potentially spiraling healthcare costs.”

Critical Diagnostics also holds exclusive worldwide rights to the heart failure biomarker ST2. ST2 is a soluble protein expressed by the heart in response to cardiac disease or injury. ST2 levels change quickly in response to changes in the patient’s condition. In an ad hoc analysis of a cohort of heart failure patients on Entresto, ST2 was correlated with the presence and severity of disease and underlying pathophysiology.

The Presage ST2 assay is CE marked and FDA-cleared (indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure). The assay has a unique CPT code, Centers for Medicare and Medicaid Services (CMS) reimbursement, and is in the ACC/AHA Guidelines as “not only predictive of hospitalization and death in patients with HF but also additive to natriuretic peptide levels in their prognostic value.” The ST2 test is commercially available in many countries across Europe and Asia. ST2 testing is available in a rapid test format (results in 20 minutes) with the CE Marked Aspect-PLUS ST2 test and companion Aspect Reader.

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