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A SNP in the pan-SARS E gene has not affected patient results, but has raised concerns about the overall unavailability of commercial primer and probe information.
Lab firms are acquiring equipment and implementing approaches like pooled testing, but it remains unclear if this will be enough to meet a fall surge.
The company's BD Veritor Plus SARS-CoV-2 assay, which has FDA Emergency Use Authorization, is designed to detect viral antigens in nasal swab specimens.
The test, which has Emergency Use Authorization from the US Food and Drug Administration, is designed to detect the SARS-CoV-2 ORF1ab, N, and E genes.
In a local coverage article, Medicare contractors in the MolDx program added prostate cancer to the covered indications for the test.
Opko's BioReference Laboratories business processed about 2.2 million COVID-19 molecular tests during the quarter, it said.
The firm saw $109 million in sales of its COVID-19-related products, including nearly $53 million in sales of its Lyra SARS-CoV-2 molecular diagnostic assay.
The company is employing Guardant360 in a Phase III trial assessing the efficacy of the drug both in a larger population and in women who test positive for ESR1 mutations.
For the three months ended June 30, the genomic testing firm reported total revenues of $20.7 million.
The firm reported that revenues from screening products fell 34 percent year over year, but that it took in $34.6 million in revenues from COVID-19 testing.
The overall revenue decrease was buoyed by 19 percent year-over-year growth in Life Science segment revenues due to strong PCR-related sales.
The company recently said it was discontinuing development of its original and only in-house developed assay after a failed clinical validation.
On a conference call to discuss the company's third quarter financial results, executives said they increased molecular test production by 50 percent during the quarter.
Belgium's OncoDNA believes that IntegraGen's bioinformatics platform will help it manage more cancer patient data and quickly generate patient-specific treatment reports for clinicians.
The test was developed by a consortium founded in April by Omega Diagnostics, Abingdon Health, BBI Solutions, CIGA Healthcare, and the University of Oxford.
The lateral flow antibody test kit has a combined IgG/IgM sensitivity of 100 percent and specificity of almost 99 percent and received EUA in June.
The agency has provided new guidance for tests that can be used outside of a lab setting, as well as updated its guidance on a number of other topics.
PharmaCyte licensed the RT-PCR and enhanced fluorescence RT-PCR tests from Hong Kong-based Hai Kang Life.
Strong demand for the firm's COVID-19 molecular tests for the Panther and Panther Fusion platforms offset revenue declines in other areas of the business.
With revenues of $143,000, the company incurred a net loss of $9.1 million, or $0.14 per share, for the quarter, exceeding the consensus Wall Street estimate.