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The firm's variety of COVID-19 molecular and immunoassay test offerings offset declines in the point-of-care segment.
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 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.
The Italian diagnostics firm believes its test can ID patients with high viral loads rapidly who need to be treated quickly.
The company first submitted for 510(k) clearance last year and has received two additional information requests from the agency.
The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.
The test has shown almost 100 percent specificity and 95 percent sensitivity in patients tested 15 days after the onset of symptoms.
Spectrum Solutions' specimen collection device is used with SARS-CoV-2 saliva tests from DxTerity Diagnostics and RUCDR Infinite Biologics.
Reimbursement and liability issues will be impacted by FDA's decision, while LDT users could find it difficult to assess the quality of the new tests.