Predictive Health Diagnostics Company, Inc., a diagnostics platform company that develops, manufactures, and distributes specialty diagnostic tests combining science, technology, and proprietary analytics to detect diseases with significant unmet medical needs, today announced a partnership with Alabama-based Madison Core Laboratories (MCL) for distribution of the PULS Cardiac Test™ to patients throughout the organization’s expansive network of high at-risk patients. MCL is a state-of-the-art, full-service independent clinical laboratory servicing physicians’ offices, long-term care facilities, assisted living facilities, homebound patients, addiction clinics, and industrial/corporate testing needs.
“Our partnership with MCL illustrates our strategic plan to partner with labs in specific markets that can help drive the value and clinical utility of the PULS test to save lives, improve outcomes, and advance how cardiovascular diseases are evaluated,” said Matthew Nuñez, Chief Executive Officer of Predictive Health Diagnostics Company. “Through more than 30 facilities, MCL focuses on delivering care to high-risk patients with comorbidities, many of whom can benefit greatly from our PULS test which determines a risk score for coronary artery inflammation and predicts the likelihood of a heart attack within five years. MCL is an ideal partner for PHDC as both companies share the same mission: to deliver the fastest and most accurate diagnostic testing results for improving and saving lives.”
The PULS (Protein Unstable Lesion Signature) Cardiac Test is a prevention and intervention tool that measures the most clinically-significant protein biomarkers that measure the body’s immune system response to arterial injury. These injuries lead to the formation and progression of cardiac lesions which may become unstable and rupture, leading to a cardiac event. The PULS Test provides valuable information that can be used to determine the most appropriate course of action for at-risk patients according to clinical guidelines.
PHDC has also developed a PULS Cardiac Test kit for distribution through future partnerships with clinical laboratories. The kit enables other clinical laboratories to perform the test in their own laboratories instead of sending them to Predictive Health Diagnostic Company’s CLIA laboratory, Morning Star Laboratories, as required under CMS Laboratory Developed Test (LDT) regulations. The Company is planning an FDA pre-submission for this product in June 2021, and the FDA’s clinical validation process is scheduled to begin thereafter.
About Predictive Health Diagnostics Company
Predictive Health Diagnostics Company (PHDC) is a leading specialty diagnostics development platform company that develops, manufactures, and distributes medical tests combining science, technology, and proprietary analytics to detect high-risk diseases with significant unmet medical needs. PHDC’s laboratory information systems use data from multiple sources including proteomics, genetics, metabolics, biochemistry, phenotype, and imaging to address among the most challenging clinical problems. To learn more, visit PHDC at phdiagnostics.com, Twitter, Facebook, and LinkedIn.