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Quidel expects to launch at least four new products over the next year and commented on its overall COVID-19 strategy, as well as R&D plans, M&A possibilities, and other updates.
The reissued EUA is for the qualitative detection of nucleic acid from SARS-CoV-2 in human oropharyngeal swab, nasopharyngeal swab, and anterior nasal swab specimens.
The company is developing a 10-minute, lab-based antigen test as well as a quantitative antibody test that will make use of its sample prep tech.
The firm's subsidiary BioReference Laboratories performed 3.5 million COVID-19 PCR tests and 300,000 serology tests during the quarter.
The firm reported $57.8 million in revenues for its Lyra SARS-CoV-2 molecular diagnostic assays in the quarter.
The company reported $53.4 million in total revenues for the quarter and said testing services revenues rose 61 percent year over year.
The company said that at a time of unparalleled growth, it is building three new manufacturing lines and expanding resources for future assay development.
As a result of the expanded coverage, Natera said it believes there are currently 139 million people covered in the US for average risk NIPT.
Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
The CRISPR-based test uses Mammoth's DETECTR BOOST platform and will be compatible with both nasal swab and saliva samples.