Company Product Description Indication Status
Genscript Biotech Corp., of Piscataway, N.J. Cpass SARS-CoV-2 Neutralization Antibody Detection Kit Test based on enzyme-linked immunosuppressant assay Detects COVID-19 neutralizing antibodies in serum The testing strategy was validated in two COVID-19 patient cohorts in Singapore and China (with a sample size of 375 and 250, respectively); the study, published in Nature Biotechnology, directly compared the clinical performance between the cell- and virus-based detection test (cVNT) and the and surrogate virus neutralization test (sVNT), or Cpass, with results showing that the Cpass test was able to detect neutralizing antibodies from patients with 95%-100% sensitivity and 99.93% specificity
Polarityte Inc., of Salt Lake City Skinte Cellular and tissue-based product derived from a patient's own skin Treatment of diabetic foot ulcers Reported positive results from a protocol-specified interim analysis of the first 50 patients enrolled in a multicenter randomized controlled trial evaluating treatment of diabetic foot ulcers with Skinte plus standard of care (SOC) vs SOC alone; 50 patients were evaluated across 13 sites with 25 patients receiving Skinte plus SOC and 25 patients receiving only SOC; 72% of patients treated with Skinte plus SOC achieved wound closure by 12 weeks vs. 32% of patients treated with SOC alone (p=0.005)


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