Peripheral arterial disease (PAD), one major type of cardiovascular diseaseS, impacts >15 million people in the US. Progression of PAD leads to chronic limb threatening ischemia (CLTI) and presents NO.1 trigger of amputation. The key challenge for PAD treatment is lack of effective and easily acquired indicators of disease severity, which doctorS needed to prescribe different treatment plans to effectively manage clinical conditions. The classical blood test on lipid profile has no insights on this clinical condition at all.
We have discovered an innovative biomarker specifically indicating progression level of PAD. This biomarker, named circulating serum fatty acid synthase (cFAS) is highly accurate, and robust to clinical conditions such as diabetes and medications such as statin. It has been verified over 200 patients and patented through WashU. The technology can be seamlessly integrated into existing lab test system in hospitals as well as LabCorp and Quest. We plan to commercialize this technology through large scale clinical trial and produce a diagnostic cFAS test kit based on this technology.
The market size for cardiovascular diagnostic tests is over 1.5 billion tests per year in the US with a CAGR > 9% over the next 5 years. Our cFAS biomarker technology will be FDA cleared to market via a 510(k) regulatory pathway. A major U.S. diagnostic company has shown considerable interests in this technology and in active conversations on potential collaborations.