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The study will compare whole-genome sequencing and RNA sequencing to conventional diagnostic methods in about 450 acute leukemia patients in Sweden.
Webb Diagnostic has placed an initial order worth about C$3.5 million for MedMira's RevealCOVID-19 Total Antibody Test.
The assays quantitatively measure the activity of galactose-1-phosphate uridylyltransferase and biotinidase enzymes from newborn dried blood spot specimens.
The decline was attributed to SARS-CoV-2's impact on sales of Trinity's infectious disease and diabetes products, as well as its autoimmune testing services.
The bills would award grants to help public health laboratories purchase high-throughput instruments and to help support diagnostic testing outside of the lab setting.
JTCC will adapt validated tests developed by GTC for DNA and RNA profiling of all cancers in its patients with solid tumors of blood cancers.
The tests will run on Bosch's automated Vivalytic platform, with BioGX developing, manufacturing, and supplying reagents for the cartridges.
The test kit is designed to detect regions of the virus' nucleocapsid and envelope genes in upper respiratory specimens and bronchoalveolar lavage.
The Dutch firm announced a deal earlier in the month to develop the test with Duke-NUS Medical School and the Diagnostics Development Hub in Singapore.
Todos said it believes that gaining access to a medical grade ventilator will bring further attention to its coronavirus tests.
The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
Hygea's software platform will help physicians order and manage genetic tests, such as Admera Health's PGxOne Plus pharmacogenomic test.
The company plans to use the proceeds for general product R&D, for reimbursement studies in the US, and for preparation for potential COVID-19 testing.
The rapid diagnostic test-strip kit is designed to detect immunoglobulin G and M antibodies against the virus in whole blood, serum, and plasma.
The automated antigen test is available as part of a multianalyte respiratory test panel for 11 common pathogens and as a single-target test.
Bio-Techne said pathologists now have access to its fully automated RNAscope technology, providing them with a new tool to evaluate disease biomarkers.
Under the agreement, NeoGenomics will also make a $25 million equity investment in Inivata with an option to buy the company outright.
The company said it is targeting production of more than 50 million tests per month, which can run on 20,000 globally installed Siemens systems.
The three RT-PCR-based tests are only authorized for use at their respective developers' CLIA-certified laboratories, according to the FDA.
ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).
All three kits run on authorized PCR instruments and may be performed by any laboratory CLIA-certified to perform high-complexity tests.
The test is authorized for a variety of samples, including oral fluid collected with OraSure Technologies' Omnigene Oral OM-505 saliva collection device.
Roche said the acquisition is expected to advance development of its nanopore sequencer by providing access to Stratos' Sequencing by Expansion chemistry.
During evaluations of 180 randomized specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100 percent sensitivity and 98.2 percent specificity, the firm said.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.