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The authors said they aimed to provide guidance given the varied performance of available serology tests and the evolving understanding of their utility.
Earlier this year, Assure Tech's Ecotest COVID-19 serological rapid test for SARS-CoV-2 infection received authorization from Canadian regulators.
Oncgnostics also expects the test to be approved by regulators in Canada and to be sold there by the end of the year.
The automated sample-to-answer platform allows for a variety of assay types to be run simultaneously, such as molecular, immunochemistry, and cytometry tests.
The chemiluminescent immunoassay may be used by laboratories CLIA-certified to perform moderate- or high-complexity tests, the FDA said.
The hybridization-based test may provide better detection of emerging COVID-19 variants of concern, due to a higher tolerance for probe mismatches than in PCR.
Scipher will use the proceeds to further commercialize PrismRA, a molecular test intended to guide treatment decisions for patients with rheumatoid arthritis.
PWNHealth will be rebranded as Everly Health Solutions and will operate as an independent subsidiary of newly-formed parent company Everly Health.
The company was founded in 2017 to commercialize a small, battery-powered, disposable RT-PCR system called the Nuclein Hand-Held PCR Test.
NeoGenomics will offer Trapelo's clinical decision support system to providers, payors, and labs to aid precision oncology across all healthcare settings.
The firm used the proceeds to repay outstanding borrowings of $25.9 million under its existing loan with Innovatus Life Sciences Lending Fund.
The review, which Goldman Sach will advise on, is possibly a response to activist investor Jana Partners, which bought a large stake in the company last year.
The country tested more than 80 percent of its eligible population over two weeks and saw substantial drops in virus prevalence and hospital admissions.
With support from Color and through a network of testing laboratories, Thermo Fisher will offer integrated COVID-19 testing to school districts nationwide.
The partners believe the platform, which captures high resolution images of CTCs and clusters, has potential applications in early cancer detection and disease monitoring.
The company said the test detects four SARS-CoV-2 variants and two biologically significant mutations, all of which are now prevalent globally.
The firm's CEO said that its MDx system is available for research use and going through CE-IVD marking ahead of its full commercial launch.
The test is fully automated from sample to result interpretation and requires one whole-blood sample tube with no manual sample preparation necessary.
The test measures IgG antibodies directed to the spike protein of the virus and has demonstrated 99.9 percent specificity and 98.9 percent sensitivity.
The financing will go toward the expansion of the company's laboratory operations and acceleration of the sales and marketing efforts of its Syn-One Test.
CellMax also completed a Series C financing round to speed up development of itsFirstSight liquid biopsy test to detect colorectal cancer and precancer polyps.
Todos said that after implementing its automation equipment, Majl will be able to run approximately 1,500 PCR-based COVID-19 tests per day.
The firm said it will begin running its urine-based test immediately in its clinical laboratory in Munich and make it available throughout Europe.
Artificial will provide access to its aLab Suite software, which integrates with the Thermo Scientific Momentum Workflow software and robotics hardware.
The company said it plans to use the proceeds to develop multiomics capabilities, including building out its clinical laboratory.