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The third quarter continued Abbott's streak of offsetting base business declines with COVID-19 testing, with 38 percent growth in the diagnostics business.
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.
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 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.
The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes has been used for more than a decade to assess immune function in HIV patients.
The Mountain View, California-based firm will first offer the system for evaluation and clinical use in France and the United Kingdom.
The ELISA-based test, which has CE marking, uses protein signatures in blood to detect the onset of kidney disease in type 2 diabetics.
CMS will now only reimburse labs performing high-throughput COVID-19 testing at the highest payment rate if they complete testing within two days of specimen collection.
The company has plans to launch another SARS-CoV-2 antigen test, as well as an immunoassay to detect Epstein-Barr virus in the fourth quarter.
Myriad Genetics' EndoPredict, Agendia's MammaPrint (distributed in Germany by PathoNext), and Veracyte's Prosigna will now be covered by public insurance.
Novacyt said that the acquisition secures important intellectual property for its q16 and q32 rapid-PCR instruments for near-patient testing of COVID-19.
MDx revenues grew 67 percent while centralized and POC solutions revenues were down 13 percent, tissue Dx slid 1 percent and diabetes care declined 10 percent.
Following its recent acquisition of Curetis, OpGen has also shifted its focus onto its Unyvero molecular diagnostics platform and bioinformatics operations.
The partners will integrate CCPM's research biobank with personalized genomic information to develop and commercialize the saliva-based tests.