Tangen will use the proceeds to scale up manufacturing for its SARS-CoV-2 point-of-care test and accelerate development of a panel test including SARS-CoV-2 targets.
The firm said that its financial results for the second quarter of 2020 reflected the impact of an FDA revocation of an EUA for its DPP COVID-19 IgM/IgG System.
The companies are validating the Genedrive 96 Sars-CoV-2 kit using saliva samples extracted with Beckman Coulter's RNAdvance viral extraction chemistry
The firms are using the technology, previously employed by Biocept exclusively for blood-based cancer testing, to develop a highly sensitive COVID-19 diagnostic.
The company said that in response to the letter, it is recalling all non-Luminex temperature verification fixtures from the field for its Verigene SP instrument.
Company officials credited investments in information technology, as well as R&D for RT-PCR-based tests, with driving up the firm's billable testing numbers.
The viral assay, developed with Sentinel Diagnostics, improves the ability to monitor viral loads in critical organ transplant populations for the clinical management of infection.
The PCR diagnostic device is a palm-size, single-use, disposable device that detects N. gonorrhoeae and determines if it's susceptible to an antibiotic.
Germany's Federal Ministry of Health issued an order last Friday making testing freely available to returning travelers within 72 hours of entering the country.
The PCR viral load test runs on the Cobas 6800/8800 systems and has been calibrated to the World Health Organization International Standard, Roche said.
