NEW YORK – Chembio Diagnostics announced this week that it has submitted its DPP HIV-Syphilis System to the US Food and Drug Administration for a CLIA waiver. The system is a multiplex, single-use test designed to run on the firm's DPP Micro Reader analyzer that simultaneously detects antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis. The test uses fingerstick whole blood, venous whole blood, or plasma and returns results in 15 minutes, the company said in a statement. The system received premarket approval from the FDA in 2020. Last year, Chembio said that the agency had requested additional data for the company's CLIA-waiver submission.
Thermo Fisher Scientific said this week that it has updated the Applied Biosystems 3500 and 3500xL Dx Genetic Analyzer capillary electrophoresis instruments to comply with Europe's In Vitro Diagnostic Regulation (IVDR). The IVDR-compliant versions and corresponding consumables are now available in most EU countries.
Renalytix this week reported that its fiscal first quarter revenues more than doubled to $969,000 from $482,000 a year ago. The company said that it performed more than 1,200 KidneyIntelX tests in fiscal Q1, with over 80 percent of those tests billable. KidneyIntelX uses a machine-learning enabled algorithm to process predictive blood biomarkers with key features from a patient's health record to generate a kidney health risk score. The London- and Salt Lake City-based firm noted that 30 private insurance and network provider contracts have now been executed for the assay. Renalytix incurred a Q1 net loss of $12.0 million, or $.16 per share, compared to a net loss of $10.1 million, or $.14 per share, a year ago. The company ended the quarter with $31.0 million in cash and cash equivalents.
Proteomics-based cancer precision medicine company Theralink Technologies said this week that the College of American Pathologists has accredited its reverse phase protein array laboratory in Golden, Colorado, based on results from a recent on-site inspection. The lab is now both CLIA-certified and CAP-accredited.
NGeneBio said last week that it has signed a deal with the National Unified Procurement company (NUPCO) in Saudi Arabia to supply its next-generation sequencing panel for hematological malignancies, HemeaccuTest. Under the contract, NGeneBio expects to deliver about 4,000 kits over two years, starting in Q1 2023, through a local distributor. The test, which analyzes DNA and RNA and comes with NGeneAnySys analysis software, is currently being evaluated at Saudi hospitals.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.