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The company's adaptive low-resource testing technology requires no instrumentation and limited equipment, making it adaptable to settings without clinical lab infrastructure.
The three RT-PCR-based tests are only authorized for use at their respective developers' CLIA-certified laboratories, according to the FDA.
All three kits run on authorized PCR instruments and may be performed by any laboratory CLIA-certified to perform high-complexity tests.
The test is authorized for a variety of samples, including oral fluid collected with OraSure Technologies' Omnigene Oral OM-505 saliva collection device.
During evaluations of 180 randomized specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100 percent sensitivity and 98.2 percent specificity, the firm said.
More than a dozen studies have been published to date directly comparing molecular diagnostic COVID-19 tests, with some detecting differences, mostly in sensitivity.
Single-cell analysis, next-generation sequencing, and synthetic DNA have all been crucial to efforts to find antibodies that could neutralize SARS-CoV-2.
With a €930,000 from Horizon 2020, the firm is conducting additional stories to evaluate other uses for the test, including using new specimen types and patient cohorts.
British bioinformatics firm PrecisionLife has mined the UK Biobank to identify genetic risk factors for late-stage COVID-19 patients developing sepsis.
The RT-PCR test targets the N gene and E gene regions of the SARS-CoV-2 genome in a multiplex format.
A professor of pathology and laboratory medicine, Gregory Tsongalis has published a paper detailing his lab's work on SARS-CoV-2 testing and the challenges faced.
Low levels of lymphocytes appeared to predict disease severity among a cohort of more than 300 COVID-19 patients, while viral genetic differences did not.
In a study published last month, Mammoth demonstrated the technology's sensitivity, specificity, and speed compared to PCR-based COVID-19 testing.
The test does not require thermal cycling and uses a colorimetric readout, making it more amenable to high-throughput automation and rapid scale-up, the company said.
The companies are making three COVID-19 tools available immediately for early access, with plans to add other nCounter software and potentially develop new products.
The firm said it will use the funds for general corporate purposes, which may include investment and acquisitions, working capital, and debt repayment.
The companies collaborated in Wuhan during the COVID-19 outbreak, using Darui's pathogenic microorganism detection kits on Genetron's next-generation sequencer.
French startup SeqOne has adapted its sequencing data-analysis platform to support a new method for high-throughput processing of coronavirus tests in its home country.
A handful of recently published trials suggest that use of the pneumonia panel could lead to more targeted therapy delivered more quickly than standard methods.
The two organizations announced a partnership earlier this year to manufacture and process Curative's oral fluid-based SARS-CoV-2 test.
A study of families explores how children transmit SARS-CoV-2, according to the Associated Press.
US Agricultural Research Service scientists have sequenced the genome of the Asian giant hornet.
According to the Economist, pooled testing for COVID-19 could help alleviate strains on testing labs.
In Science this week: MIT researchers outline approach dubbed translatable components regression to predict treatment response among IBD patients.