NEW YORK – Quest Diagnostics this week announced it has received breakthrough device designation from the US Food and Drug Administration for an assay to detect adeno-associated virus (AAV). The enzyme-linked immunosorbent in vitro diagnostic assay is for semi-quantitative detection of IgG antibodies to AAVrh74 capsid in human serum. It is intended to help identify patients eligible for treatment with Sarepta Therapeutics’ Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for Duchenne muscular dystrophy.
Centogene said this week that it has received notification from the Nasdaq of non-compliance with the minimum market value of publicly held shares (MVPHS) rule for continued listing on the exchange because its MVPHS fell below $15 million for 30 consecutive business days. The German molecular diagnostics firm now has until Feb. 26, 2024 to regain compliance by obtaining a MVPHS of at least $15 million for 10 consecutive business days. If it does not regain compliance, the firm will be notified that its securities are subject to delisting. In July, the company had already regained compliance with the MVPHS requirement once after failing to meet it in June.
Exact Sciences said this week that the National Cancer Institute has chosen the company as a participant in a precision medicine initiative called ComboMATCH. As a ComboMATCH-designated lab, Exact will use its recently launched OncoExTra test, a comprehensive next-generation sequencing assay, to analyze tumor tissue and paired normal blood samples from patient participants. Funded by the NCI, ComboMATCH involves an initial registration trial, which serves as the gateway to a set of clinical trials evaluating new anti-cancer treatment combinations directed by NGS testing in select groups of adults and children with locally advanced or advanced cancer.
Eiger Diagnostics announced this week that it has officially launched with Dave Lambillotte serving as founder and president and Ted Sheridan serving as VP of marketing and business development. The new firm plans to commercialize a line of ELISA-based IgG and IgM diagnostic test kits and components to detect parasitic infections and other infectious diseases. Eiger intends to provide these assays as an OEM vendor and also as finished kits through a network of worldwide distributors.
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.