- Company announces its business strategy including test development, commercialization, intellectual property, and reimbursement initiatives
- Data-driven technology platform innovates specialty diagnostic tests for diseases with the largest unmet medical needs
Irvine, CA /PRNewswire/ - Predictive Health Diagnostics Company, Inc. ("PHDC" or "the Company"), a diagnostics development 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 its business strategy and development plan, including upcoming corporate milestones.
"PHDC's diagnostic tests combine cutting-edge science with the most effective technology to conquer some of the biggest challenges in healthcare," said Matthew Nuñez, Chief Executive Officer of Predictive Health Diagnostics Company. "We launched our lead cardiovascular test, the PULS Cardiac Test™, in 2018, and we reached a major milestone in December 2020 with our 100,000th test order. Heart disease is 80% preventable, and with the PULS Cardiac Test, we offer a one-of-a-kind, non-invasive way to detect the underlying risk of a heart attack early on, when prevention is most effective. We will soon execute the rollout of our other pipeline products in diabetes and oncology. Next will be DIABETESpredict™, a new way to intervene in Type 2 diabetes by identifying risk – even before symptoms or abnormal tests."
"Our team has spent the last three years creating an industry-leading diagnostics development platform that gives us the unmatched ability to innovate," Nuñez continued. "Utilizing our proprietary computational technology, PHDC goes from data to realized diagnostic test with greater speed and lower development costs than our closest competitors in the diagnostics market."
The PULS Cardiac Test™
The PULS Cardiac Test is a diagnostic blood test that identifies asymptomatic patients at risk of a heart attack that are missed by current standard of care. The test detects inflammation in the lining of the coronary arteries associated with formation of unstable soft plaque that is prone to rupture, leading to a heart attack. This soft plaque is the leading cause of heart attacks, contrary to the widespread perception that hard plaque is the cause. More than 75% of heart attacks are caused by rupture of these unstable soft plaques. Because these lesions do not restrict blood flow until they rupture, there is no warning symptom for these individuals – their first "symptom" is a heart attack or death. PULS Cardiac Test results determine a risk score that quantifies coronary artery inflammation and predicts an individual's risk of a heart attack in the next five years, a time frame during which preventative cardiology and lifestyle changes can take effect successfully. Cardiac disease is the number one cause of death worldwide, affecting over 120 million Americans.
Currently, the PULS Cardiac Test may be ordered and administered by healthcare providers. A new fingerstick collection device, presently in late-stage development, will be marketed via several new distribution channels with launch planned for later this year.
PHDC has also developed a PULS Cardiac Test kit for distribution through clinical laboratories. 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.
DIABETESpredict, a new way to identify type 2 diabetes risk before symptoms or abnormal labs are discovered, was developed by PHDC in collaboration with the SIGMA PROJECT partners (Massachusetts General Hospital, and the Broad Institute at both MIT and Harvard).
Successful licensing of DIABETESpredict was completed in late 2020, and commercial launch is expected in June 2021.
Commercializing Laboratory Developed Tests (LDTs) via the CLIA (Clinical Laboratory Improvement Amendments) regulatory process
PHDC will continue to develop and launch its specialty diagnostic tests to market using its CLIA- and College of American Pathologists (CAP)-certified laboratory while utilizing its national sales team and pursuing FDA approval for specific kit sales.
Licensing LDTs to strategic partners
PHDC will seek engagements with international partners to gain market entry globally. The Company has signed a distribution agreement with Prodia Clinical Laboratory to provide the PULS Cardiac Test to the people of Indonesia, and has secured distribution of the PULS test throughout China upon acceptance through the FDA. The PULS test is currently distributed in Canada through LifeLabs.
Intellectual Property Strategy
PHDC has a proprietary biorepository of more than 120,000 patients with millions of data points. This enables future test development for PHDC without the need to purchase samples or run extensive trials to collect samples. Additionally, strong relationships with leading oncology institutions throughout the world position PHDC to continue innovating well into the future.
About Predictive Health Diagnostics Company
Predictive Health Diagnostics Company (PDHC) 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.
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