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The company also said that it had received EUA from the US Food and Drug Administration for a non-prescription version of its COVID-19 sample collection kit.

The company's cartridge for pneumonia for the Unyvero system is under review and pending approval by Chinese regulators.

The firm said it is currently also developing Novodiag Resp-4, a molecular test for the rapid, on-demand detection of the viruses.

The products combine next-generation sequencing and analysis with the company's NGSengine software to provide high-resolution HLA genotyping information.

The firm said its test eliminates the need for automated extraction systems in a high-volume PCR laboratory, reducing processing time, cost, and labor.

Cue said that US-based K-12 schools, essential businesses, nursing homes, hospitals, and physicians' offices are already using its COVID-19 test. 

The company, which had received a request from the FDA for more information on the test, is planning additional studies before resubmitting the application.

The agency cautioned test companies that the presence of mutations in the virus could lead to false negative results.

The institute offers a rapid whole-genome sequencing test designed to diagnose infants and children suspected of having a rare genetic condition.

With the EUAs, a sample collection kit from Everlywell and tests from Gravity Diagnostics and Assurance Scientific may be used without a prescription.

All the tests are authorized for use by CLIA-certified labs, while Visby's test may also be performed in a point-of-care setting.

The firm's stock price has dropped since the announcement that the agency would need additional information and it has paused test shipments.

In December, the firm was named a finalist in a $6 million Xprize competition to develop a rapid test for detecting SARS-CoV-2.

The PCR-based test, which is also now CE marked, provides a positive or negative result for each virus using a single specimen within three hours.

The test was previously cleared by the FDA for use with ethylenediaminetetraacetic acid plasma samples to manage BK virus in transplant patients.

The firm's CEO said that the deprioritization of its submission for a standalone SARS-CoV-2 assay running on its Verigene I molecular diagnostic instrument is puzzling.

While the tests from Clinomics, UPenn, and Inno Diagnostics detect the SARS-CoV-2 virus, Princeton BioMeditech's test differentiates between SARS-CoV-2 and influenza.

The device also has Emergency Use Authorization from the US Food and Drug Administration and has CE marking for in vitro diagnostic use.

The test uses primers and probes from Thermo Fisher Scientific's authorized TaqPath COVID-19 Combo Kit with a modified results interpretation algorithm.

Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay is an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus.

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Researchers are developing a breath test to determine how severe patients' methylmalonic acidemia disease is, FierceBiotech reports.

NPR reports that vaccine developers are working on SARS-CoV-2 vaccines that are easier to store or administer than the current crop.

Reuters reports that France is to recommend that people under 55 who received one dose of AstraZeneca's SARS-CoV-2 vaccine receive a different vaccine for their second dose.