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While some commentators have blamed FDA, many test developers say the agency hasn't been an issue and that, in fact, they are making speedy progress.
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 also announced two new instruments that would diversify its product offerings.
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 agreement aims to develop and validate a scaled-up manufacturing process to enable the production of millions of tests per month.
The Vela and Capstone tests are both PCR-based and designed to detect their viral RNA targets in nasopharyngeal and oropharyngeal swab specimens.
The firm said declines across most business areas were slightly offset by increases in sales of sample collection devices.
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.
The governors of the six states are collaborating with the Rockefeller Foundation to expand access to point-of-care antigen testing for SARS-CoV-2.
The prize, organized by the British innovation foundation Nesta, has assembled a series of workshops and support sessions to help prize competitors.
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.
The tests use a range of different specimens including self-collected nasal swabs, bronchoalveolar lavage, sputum, and nasopharyngeal washes.
The genetic testing company said its orders for traditional tests have also rebounded and are on track for growth in the second half of 2020.
GenMark has two SARS-CoV-2 tests that have received FDA Emergency Use Authorization, including a respiratory panel that tests for 21 pathogens.