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The president-elect's plan would provide funding to purchase rapid tests and investments to expand lab capacity.
Released by the Pandemic Response Accountability Committee, the report looks at data on test volume, turnaround, cost, and usage at six federal agencies.
News items for the in vitro diagnostics industry for the week of Jan. 11, 2021.
The contract was awarded under DARPA's Detect It with Gene Editing Technologies program, which aims to create a device to detect at least 10 pathogens.
The test has been authorized for use with individual respiratory specimens, as well as with pooled specimens containing up to five samples.
Invitae is working with Bristol Myers Squibb, Janssen, Novartis, and Genentech to advance an NGS panel to gauge the efficacy of AML treatments in trials.
The company continues to face regulatory challenges in the US, but received CE marking for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems.
The company said it expects core molecular testing revenue between $115 million and $125 million and SARS-CoV-2 revenue between $15 million and $20 million.
Exact Sciences discussed newly released data and its plans for Cologuard, while Luminex provided details about its warning letter from the FDA.
The company said it will use the funding to continue development of its computational technologies, biomarkers, and diagnostics, as well as for new hires.
The firm plans to begin its OTC efforts with a COVID antigen test but also sees potential in migrating other infectious disease tests.
Using its xT sequencing platform, Tempus will create a companion test to identify patients eligible for treatment with A2's cell-based LOH-targeted therapy.
The funding will be used to validate the Simplexa COVID-19 Direct kit and Simplexa COVID-19 & Flu A/B Direct kit and to submit them to the FDA for 510(k) clearance.
Oxford Immunotec's T-Spot Discovery SARC-CoV-2 test will be used to assess whether Valneva's vaccine candidate induces a T-cell response.
ZeptoMetrix develops and manufactures quality control standards and verification panels used in infectious disease molecular diagnostic testing.
The company also projected full year 2020 revenue of between $84 million and 86 million and said that its instrument install base grew 34 percent over the year.
Laboratories that purchase PGDx Elio genomic profiling tests will receive access to Qiagen's QCI Interpret One for rapid, evidence-based variant interpretation.
Despite the Q4 revenue increase, sales for FY2020 dropped 13 percent year over year to $5.2 million.
Qiagen discussed what's in store after a failed bid by Thermo Fisher Scientific, and COVID-19 remained a hot topic on the second day of the virtual conference.
The partners will use PacBio's HiFi sequencing to develop assays for carrier screening, evaluating immune system responses, and diagnosing heritable diseases.
The firms are focusing an initial program on the development of a companion diagnostic test for HiberCell’s immunotherapy, Imprime PGG.
The fluoro-enzyme immunoassay is designed for the qualitative and semi-quantitative detection of immunoglobulin G against SARS-CoV-2.
Last year, the company processed more than 1 million tests, most of them for its reproductive health business, but interest in Prospera and Signatera is growing.
Ortho said that it currently can deliver 5 million tests per month and will be able to increase that figure to 15 million tests per month in February.
Federal prosecutors alleged AutoGenomics paid nursing home patients to get tested in exchange for being referred for testing.