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The skin cancer diagnostics company said it delivered 5 percent fewer DecisionDx-Melanoma test results in Q4 2020 than in the previous year's fourth quarter.
Quest will pick up the business from 29 Mercy hospital labs and two independent clinic labs servicing patients and providers throughout the Midwest.
Bio-Rad will provide Roche's customers with InteliQ quality control products, Unity QC data management, as well as training and support.
The firm said its assays help clinicians understand each patient's adaptive immune response to SARS-CoV-2, acquired through infection or vaccination.
The testing program is part of a strategy to lift restrictions in the UK.
The test leverages immune repertoire sequencing technology to identify individuals who have had a recent or prior SARS-CoV-2 infection.
The assay from San Diego-based Cue is the first molecular test authorized by the US Food and Drug Administration for home use without a doctor's prescription.
The tests are expected to become widely available to consumers through supermarket chains, drug stores, pharmacies, and online sales starting March 6.
The company also said that a previously granted EUA for its Alinity m SARS-CoV-2 assay has been expanded to include asymptomatic individuals and pooled testing.
R-Pharm, Illumina's strategic partner in Russia and the Commonwealth of Independent States (CIS), led the registration process with the Russian regulatory agency.
For the three months ended Dec. 31, 2020, the La Jolla, California-based firm posted $2.1 million in revenues, up from $1.6 million in Q4 2019.
News items for the in vitro diagnostics industry for the week of March 1, 2021.
The firm plans to use $561 million of the net proceeds to fund the majority of its planned $591 million acquisition of Oxford Immunotec.
The Temple City, California-based firm delivered approximately 3.2 million billable tests in the quarter and recorded $295.0 million in revenues.
The firm said its T-cell test complements serology testing and provides a more comprehensive view of the adaptive immune response to SARS-CoV-2 infection.
The company said that it sold 57 T2Dx instruments in 2020, including 47 in the US, more than doubling its US installed base.
C2i said that the acquisition would help it commercialize its MRDetect cancer monitoring platform as a reimbursable laboratory-developed test.
Based on full approval from the FDA based on the Phase III CROWN trial, Pfizer can now market the drug as a front-line option for ALK-positive NSCLC patients.
The test is designed to assess the risk of a person developing severe disease if they contract COVID-19 based on a combination of genetic and clinical factors.
The firm said that with the addition of a target for SARS-CoV-2, its high-throughput NxTag syndromic respiratory panel includes 19 viral and two bacterial targets.
The firm plans to use the proceeds to fund the redemption of senior notes due in 2022 and for general corporate purposes.
The company is using the funds to develop a blood-based test that uses infrared spectroscopy and artificial intelligence for early-stage cancer detection.
Bio-Techne said Asuragen's headquarters in Austin, Texas includes a scalable 50,000-square-foot manufacturing facility and CLIA-certified laboratory.
Michael and Regan Dube will pay a total of $9,015,046, plus interest as a result of their convictions. Regan Dube was previously sentenced in November.
QiaCube Connect MDx is designed specifically for IVD applications, and automates DNA, RNA, and protein sample processing using Qiagen spin column technology.