Company Product Description Indication Status
Natera Inc., of San Carlos, Calif. Prospera test Measures the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood Identifies allograft rejection in organ transplant patients Published a prospective, randomized controlled trial showing clinical utility of the Prospera test in kidney transplant patients; concluded that practicing nephrologists who used Prospera detected more cases of rejection and made better clinical decisions than physicians in the control group; use of Prospera led to a 300% increase in probability of confirming rejection via biopsy in both routine and in ambiguous clinical scenarios; nephrologists using Prospera to identify rejection more than doubled the appropriate referrals to transplant centers and/or biopsies; Prospera results yielded a 137% improvement in treatment decisions that preserved kidney function; the study was published in International Urology and Nephrology
Neurometrix Inc., of Woburn, Mass. DPNcheck Point-of-care nerve conduction device Determines the severity of diabetic peripheral neuropathy (DPN) Study validating DPNcheck was published in the Journal of Diabetes Investigation; used a multiple regression analysis to examine associations of nerve conduction parameters obtained from DPNcheck with the severity of DPN categorized by Baba's classification among 375 participants with type 2 diabetes; using cut-off value with 1.3065 in the model, moderate to severe DPN was effectively diagnosed (area under the receiver operating characteristic curve 0.871, sensitivity 70.1%, specificity 87.7%, positive predictive value 83.0%, negative predictive value 77.3%, positive likelihood ratio 5.67, negative likelihood ratio 0.34)
Sherlock Biosciences Inc., of Cambridge, Mass. Sherlock CRISPR SARS-CoV-2 kit Uses a CRISPR-based method to detect and quantify specific genetic sequences Detects nucleic acid from SARS-CoV-2 Reported data from a 20-patient clinical sample pilot study conducted at Dartmouth-Hitchcock Medical Center; Sherlock test results were 100% concordant with results from Dartmouth-Hitchcock's lab-based polymerase chain reaction test method

Notes

For more information about individual companies and/or products, see Cortellis.