Canada-based medical diagnostics company Asep Medical has received US patent approval for an AI-based sepsis diagnostic technology, dubbed SepsetER.
SepsetER is a blood-based gene expression assay that enables earlier and quicker estimation of sepsis risk and facilitates targeted treatment.
The US patent, which is exclusively licenced to Asep’s subsidiary Sepset Biosciences, validates the company’s AI-based approach to sepsis diagnosis.
The patent approval in the US follows the patents awarded to the medical diagnostics company in Europe and Australia in November last year.
Asep said that the patents will strengthen its business since the test is in advanced development and in preparation for formal clinical studies to support US regulatory submission.
The US Food & Drug Administration (FDA) approval through the 510(k) pathway involves a single clinical study.
Upon securing the FDA approval, Asep intends to market the assay for use in emergency rooms and intensive care units worldwide.
Asep Medical CEO Robert Hancock said: “Patents are the lifeblood of biotechnology companies like ours. This new patent in the US once again validates the novelty of our technology in major markets, which now represents over 700 million people.”
The SepsetER test identifies the dysfunctional immune response underlying sepsis, helping physicians make early decisions to improve the prognosis and survival of the patient.
The blood-based gene expression assay can be implemented using existing equipment in most hospital labs to obtain results within 60 to 90 minutes.
Asep said that its SepsetER test is designed to enable physicians to quickly assess the severity of the disease and start urgent patient treatment.
Recently, Asep Medical, through its subsidiary Sepset Biosciences, signed a definitive joint venture (JV) agreement with Chinese medical diagnostic company Sansure Biotech.
Sansure is participating in the JV through its subsidiary, Hunan Xiang Jiang Sansure Biotech Fund, which is formed by Sansure, Changsha Sanway Spring Venture Capital and other investors.
