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About 3.4 million people, or 6 percent of the population in England, was likely infected by SARS-CoV-2 by July 13. People of color had higher rates of infection.
The firm's US clinical trials came to a standstill in the second quarter, affecting its post-approval study for the Epi proColon colorectal cancer liquid-biopsy test.
Both tests can be run on standard PCR systems, while Biomeme's is also designed to run on the company's portable, handheld Franklin instrument.
Qiagen shareholders tendered only 47 percent of the firm's issued and outstanding shares by Monday's deadline, short of the two-thirds minimum needed to complete the deal.
A partnership with Menarini Silicon Biosystems to market Menarini’s portfolio of COVID-19 related products was among its key quarterly milestones.
Although the firm has ramped up COVID-19 testing, its billable test volume and overall testing revenues both declined due to pandemic-related challenges to its core oncology business.
The FDA letters were sent to two firms advertising an antibody home test being sold on two websites and a stool test for SARS-CoV-2.
The kit, which received EUA from the FDA in May, will be used to test clinical samples from patients at D-HH member hospitals.
GeneDx will provide whole-exome and whole-genome sequencing, among other services, to neonatal intensive care units staffed with Pediatrix-affiliated doctors.
The firm said its test will enable rapid, high-volume testing in schools, manufacturing facilities, hospitals, and care homes, among other settings.
The letter cited the strain on non-COVID-19 care as laboratories struggle to meet demand for pre-procedure COVID-19 testing and other molecular tests.
Use of the two PCR-based tests is limited to their developers' CLIA-certified laboratories, according to the US Food and Drug Administration.
For the three months ended June 30, the Tucson, Arizona-based firm's revenues fell to $2.0 million from $5.8 million in the same period the year before.
The firm reissued its full-year guidance and said it expects to sell 60 instruments in the US for the remainder of the year.
Use of the test, which detects viral nucleic acid in upper respiratory specimens and bronchoalveolar lavage, is limited to George Washington University.
The immune sequencing firm also provided an update on the development of its ImmunoSeq Dx clinical product for detecting prior infection with SARS-CoV-2.
The skin cancer diagnostics company said it delivered 19 percent fewer DecisionDx-Melanoma test results in Q2 2020 than in the previous year's second quarter.
HTG will work directly with biopharma customers to build companion diagnostic development programs, with potential tests developed using either a Thermo Fisher Scientific or Illumina platform.
The in vitro diagnostic test runs on the Illumina NovaSeq 6000 instrument and will be performed at Helix's San Diego CLIA-certified laboratory.
The three tests are designed to detect antibodies, including immunoglobulin G and M, against SARS-CoV-2 in human serum and plasma.
The Clinitek Novus Automated Urine Analyzer uses dry-pad urine chemistry technology and a cassette test format to provide a variety of chemistry strip tests.
The company developed the test with labs at Emory University, Stanford University, the University of Cincinnati, and the University Health Network in Toronto.
The US Food and Drug Administration granted clearance to Diatron for an immunoassay that enables rapid screening for d-methamphetamine in human urine.
The assay provides comprehensive genomic information to oncologists from a blood draw, using targeted next-generation sequencing of circulating cell-free DNA.
The test, which is distributed in the US by Hardy Diagnostics, was found to have a low sensitivity for the IgM target.