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The FDA does not allow labs to report hs-troponin results below assays' limits of quantitation, which some argue leaves actionable information on the table.
The commercial labs will also receive testing equipment from Beckman Coulter Life Sciences and Thermo Fisher Scientific including RT-PCR instrumentation.
The US Food and Drug Administration granted clearance to Diatron for an immunoassay that enables rapid screening for d-methamphetamine in human urine.
The companies are validating the Genedrive 96 Sars-CoV-2 kit using saliva samples extracted with Beckman Coulter's RNAdvance viral extraction chemistry
For the three months ended July 3, the Washington DC-based conglomerate recorded $5.30 billion in total sales compared to $4.44 billion in the year-ago period.
The high-throughput PK7400 Automated Microplate System is designed for use in blood donor and plasma centers, as well as large reference laboratories.
According to the registry's first dataset, more than 65 million tests have been manufactured and shipped across the US.
The test detects IgG antibodies and has confirmed 100 percent sensitivity and nearly 100 percent specificity, according to the company.
The test has 100 percent sensitivity and almost 100 percent specificity, and the company has ramped its manufacturing capacity to deliver 30 million tests per month.
The award amount is about $2.3 million, BARDA said, while a Beckman Coulter spokesperson added the full contract is valued at up to $8.06 million.