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The in vitro diagnostic test runs on the Illumina NovaSeq 6000 instrument and will be performed at Helix's San Diego CLIA-certified laboratory.

Sherlock Bio recently received US Food and Drug Administration Emergency Use Authorization for the kit, which uses CRISPR to detect the virus in patient samples.

FDA officials said at ACLA's annual meeting that the agency's efforts to balance rapid test access with safety during the coronavirus crisis carries lessons for the oversight of all tests.

According to a US Food and Drug Administration webinar yesterday, a lot of IDT test kits has been qualified by CDC and is authorized for purchase.

News items for the in vitro diagnostics industry for the week of Jan. 13, 2020.

Within diagnostics, Beckman Coulter saw core revenue growth in the low-single digits, while Cepheid was up in the double digits for the quarter.

The company's Life Sciences segment was up 17 percent year over year, while its Diagnostics business grew 8 percent.

IDT will operate as a standalone company within Danaher's Life Sciences segment after the close of the deal, which is expected to occur in mid-2018.

The Hereditary Cancer Solution combines target capture probes from Integrated DNA Technologies with specialized analytics developed by Sophia.