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Released by the Pandemic Response Accountability Committee, the report looks at data on test volume, turnaround, cost, and usage at six federal agencies.

The test has been authorized for use with individual respiratory specimens, as well as with pooled specimens containing up to five samples.

The company continues to face regulatory challenges in the US, but received CE marking for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems.

The company said it expects core molecular testing revenue between $115 million and $125 million and SARS-CoV-2 revenue between $15 million and $20 million.

The firm plans to begin its OTC efforts with a COVID antigen test but also sees potential in migrating other infectious disease tests.

The funding will be used to validate the Simplexa COVID-19 Direct kit and Simplexa COVID-19 & Flu A/B Direct kit and to submit them to the FDA for 510(k) clearance.

Oxford Immunotec's T-Spot Discovery SARC-CoV-2 test will be used to assess whether Valneva's vaccine candidate induces a T-cell response.

The fluoro-enzyme immunoassay is designed for the qualitative and semi-quantitative detection of immunoglobulin G against SARS-CoV-2.

Hologic said the acquisition of Biotheranostics will give it a company that operates in markets that are adjacent and complementary to its own.

Ortho said that it currently can deliver 5 million tests per month and will be able to increase that figure to 15 million tests per month in February.

The lateral flow test can be used at the point of care and provides results within 15 minutes without the need for additional equipment, the company said.

The firm is projecting COVID-19 testing revenues of $865 million in the recently completed quarter, including $685 million in Veritor immunoassay sales.

During the quarter, the Tucson, Arizona-based company added 45 instruments for a total of 268 revenue-generating instruments installed in the US.

Separately, Siemens said that it has received CE marking for the use of its Clinitest Rapid COVID-19 Antigen Test with an additional specimen type.

For full-year 2020, the company expects revenues of approximately $417 million, which would be up 25 percent from a year ago.

The company said that in Q4 it placed 70 net new ePlex analyzers and finished the year with a global installed base of 792 analyzers.

The assay can be used to determine the immune status of COVID-19 patients and individuals who have been vaccinated against the virus, the company said.

The government said that rapid, regular testing of asymptomatic patients will be expanded to cover all 317 local authorities in the country starting next week.

The agency identified three tests potentially impacted by known mutations, and said it will continue to monitor authorized assays.

The disposable rapid antigen test uses lateral flow technology to detect SARS-CoV-2 in 15 minutes, and Everlywell will distribute it to workplaces, schools, and other organizations.

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