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The product, which received the CE mark earlier this year, uses digital imaging and AI to automate peripheral blood smear analysis.

For the three months ended Sept. 30, the Belgian molecular diagnostic firm's revenues fell to $4.5 million from $4.7 million in Q3 2019.

The firm's variety of COVID-19 molecular and immunoassay test offerings offset declines in the point-of-care segment.

Calibre Scientific said that the acquisition of Lorne Labs, a specialty manufacturer and distributor, will bolster its diagnostics division.

For the three months ended June 30, the firm reported revenues of $5.4 million, down from $6.3 million in the year-ago quarter and missing the consensus Wall Street estimate of $5.9 million.

The German diagnostics firm expects more than €80 million in 2020 revenues, driven by its recovering core business and its COVID-19 testing business.

The collaboration will involve the evaluation of serological tests to detect the durability of patients' immune response to COVID-19.

Cyted, a provider of AI and digital diagnostic technology, said the acquisition of Pathognomics will provide it with an accredited lab and digital pathology technology.

The agency issued a new draft decision memo, outlining various criteria it intends to apply when determining coverage for current and future blood-based CRC screening tests.

The US Department of Health and Human Services (HHS) said that it would use Fluidigm's saliva-based molecular SARS-CoV-2 test as part of a federal surge testing program.

Thermo Fisher's test is now authorized for use with the Everlywell COVID-19 Test Home Collection Kit, which enables individuals to self-collect nasal swab specimens.

The assay does not require nucleic acid extraction or purification, unlike a LumiraDx SARS-CoV-2 test that received Emergency Use Authorization in August.

DNA Genotek's devices are used with SARS-CoV-2 tests from Clinical Reference Laboratory and P23 Labs, while Clinical Enterprises' kit is offered by Eurofins.

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