Predictive Health Diagnostics Company’s Proprietary Computational Technology Enables Development of Specialty Diagnostic Tests to Improve Patient Care
The company announces its business strategy, including test development, commercialization, intellectual property, and reimbursement initiatives
The data-driven technology platform brings innovative specialty diagnostic tests for diseases with the greatest unmet medical need
Irvine, California., June 1, 2021 / PRNewswire / – Predictive Health Diagnostics Company, Inc. (“PHDC” or “the Company”), a diagnostic development platform company that designs, manufactures and markets specialized diagnostic tests that combine science, technology and proprietary analytics to detect diseases with significant unmet medical needs, announced its business strategy today and development known including upcoming company milestones.
“PHDC’s diagnostic tests combine cutting-edge science with the most effective technology to meet some of the greatest healthcare challenges,” said Matthew Nuñez, chief executive officer of Predictive Health Diagnostics Company. “We have our leading cardiovascular test, the PULS Cardiac Test ™, in 2018, and we reached an important milestone in 2018 December 2020 with our 100,000the Test order. Heart disease is 80% preventable, and with the PULS heart test, we offer a unique, non-invasive way to identify the underlying risk of a heart attack at an early stage when prevention is most effective. We will soon be rolling out our other pipeline products in diabetes and oncology. Next up is DIABETESpredict ™, a new way to intervene in type 2 diabetes by identifying risks – even before symptoms or abnormal tests appear. “
“Our team has spent the last three years creating an industry-leading diagnostic development platform that gives us unmatched innovation,” continued Nuñez. “By using our proprietary computing technology, PHDC goes faster and with lower development costs from data to implemented diagnostic tests than our closest competitors in the diagnostic market.”
The PULS Cardiac Test ™
The PULS heart test is a diagnostic blood test that identifies asymptomatic patients at risk of heart attack who are overlooked by current standard of care. The test detects inflammation in the lining of the coronary arteries associated with the formation of unstable soft plaques that are prone to rupture and lead to a heart attack. This soft plaque is the leading cause of heart attacks, contrary to popular belief that hard plaque is the cause. More than 75% of heart attacks are caused by the rupture of these unstable soft plaques. Because these lesions do not restrict blood flow until they tear, there is no warning symptom for these people – their first “symptom” is a heart attack or death. The results of the PULS Cardiac Test determine a risk score that quantifies coronary heart inflammation and predicts an individual’s risk of heart attack over the next five years, a time frame in which preventive cardiology and lifestyle changes can be effective. Heart disease is the leading cause of death worldwide, affecting over 120 million Americans.
The PULS heart test can currently be ordered and carried out by health care providers. A new fingertip collecting device, currently in the final stages of development, is being marketed through several new sales channels, with a launch planned for later this year.
PHDC has also developed a PULSE heart test kit for distribution through clinical laboratories. The company plans to pre-register this product with the FDA in June 2021, and the FDA clinical validation process is expected to begin thereafter.
DIABETES Prediction ™
DIABETESpredict, a new way to identify the risk of type 2 diabetes before symptoms or laboratory abnormalities are detected, was developed by PHDC in collaboration with SIGMA PROJECT partners (Massachusetts General Hospital and the Broad Institute of both) WITH and Harvard).
The successful licensing of DIABETESpredict was completed at the end of 2020 and the commercial launch is expected in June 2021.
Commercialization of laboratory developed tests (LDTs) through the CLIA (Clinical Laboratory Improvement Amendments) regulatory process
PHDC will continue to develop and commercialize its specialized diagnostic tests with its CLIA and College of American Pathologists (CAP) certified laboratory, while leveraging its national sales team and seeking FDA approval for the sale of certain kits.
Licensing of LDTs to strategic partners
PHDC will seek engagements with international partners in order to achieve global market entry. The company has signed a distribution agreement with the Prodia Clinical Laboratory to make the PULS heart test available to employees of Indonesia, and has ensured the dissemination of the PULS test throughout China upon acceptance by the FDA. The PULS test is currently distributed in Canada through LifeLabs.
Intellectual property strategy
PHDC has a proprietary biorepository with more than 120,000 patients with millions of data points. This enables future test development for PHDC without purchasing samples or performing extensive sample collection tests. In addition, close relationships with leading oncology institutions around the world enable PHDC to continue innovating in the future.
About Predictive Health Diagnostics Company
Predictive Health Diagnostics Company (PDHC) is a leader in specialty diagnostic development platforms that develops, manufactures, and markets medical tests that combine science, technology, and proprietary analytics to identify high-risk diseases with significant unmet medical needs. PHDC’s laboratory information systems use data from multiple sources including proteomics, genetics, metabolism, biochemistry, phenotype, and imaging to solve the toughest clinical problems. To learn more, visit PHDC at phdiagnostics.com, Twitter, Facebook, and LinkedIn.
Forward-looking statements are based on our current expectations and assumptions about our business, industry, and other future conditions. Because forward-looking statements address the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Our actual results could differ materially from those anticipated in the forward-looking statements. We therefore caution you not to rely on these forward-looking statements. They are neither statements of historical facts nor guarantees or representations of future performance.
All forward-looking statements made by us in this document speak only as of the date of their publication. Factors or events that could cause our actual results to differ could occur from time to time and we cannot predict them all. We do not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or for any other reason, unless this is required by law.
View original content to download multimedia:http://www.prnewswire.com/news-releases/predictive-health-diagnostics-companys-proprietary-computational-technology-enables-development-of-specialty-diagnostic-tests-to-improve-patient-care-301303359. html
SOURCE predictive health diagnostics company