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Results from the Phase II INSPIRE study showed that change in ctDNA from baseline, as gauged by customized assays, predicted response to pembrolizumab.

Zeesan's test may be used by any CLIA-certified high-complexity lab, while UCSD's test, which uses pooled samples, must be performed by the university.

Both tests can detect SARS-CoV-2 in 90 minutes and will detect viruses like influenza and respiratory syncytial virus that tend to occur in the winter.

The Clarigene SARS-CoV-2 IVD kit uses two viral RNA targets, nucleocapsid gene N and envelope gene E, which are specific to COVID-19, the firm said.

The company believes the pandemic will accelerate the adoption of its cancer diagnostics as patients and doctors look for faster and more convenient tests.

Regular SARS-CoV-2 testing could limit COVID-19 cases on university campuses but results might vary based on the schools' behavioral interventions.

CEO Doug Bryant noted, in particular, what he expects will be a hunger for rapid protein-based antigen tests for the coronavirus that the market currently can't fill.

According to the company, the test has shown to be more sensitive and accurate than a COVID-19 anterior nasal swab test in the firm's EUA validation study.

The seven technologies feature different methods, including CRISPR and microfluidics, and can be performed in many settings and with a variety of sample types.

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.

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.

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 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 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.

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The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.