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Cernostics offers an assay that analyzes whole-slide digital images with multiplexed fluorescence to help interpret Barrett's esophagus patient biopsies.
The test is based on 13 genes that form a gene signature in the blood of children with Kawasaki disease, and it enables KD to be distinguished from other diseases.
The company said that since it reported its Q2 2020 financial results, organic testing volumes for its base business have recovered faster than expected.
ArcDia's agreement with Bruker subsidiary Hain Lifescience is exclusive in Germany, Austria, Switzerland, Belgium, the Netherlands, and Luxembourg.
The firm also expects to grant the underwriters a 30-day option to purchase up to an additional $37.5 million worth of shares of its common stock.
HalioDx's Immunoscore test, which measures host immune response at the tumor site, will be used to select patients for the trial.
The new "moonshot" plan, as the government refers to it, will be based on using rapid testing of nasal swabs and saliva using platforms with a turnaround time of 20 to 90 minutes.
The new report said that point-of-care testing could rise to 70 million tests per month, or more, by October based on manufacturers' announced market entry plans.
In August, the UK government announced a 5.8 million order for DnaNudge's COVID-19 test kits to enable their rollout in UK NHS hospitals and out-of-hospital locations.
Florida's largest county joins several major California counties in deploying Fulgent Genetics' PCR-based COVID-19 tests in a drive-through setting.
The partnership will provide new point-of-care lipid testing devices to remote sites in Latin America, the Caribbean, and Asia-Pacific.
Verily's test is a modified version of Thermo Fisher Scientific's authorized TaqPath COVID-19 Combo Kit that can be used with pooled samples.
The company is developing a blood-based test to detect more than 50 cancer types across all stages and identify a tumor's tissue of origin.
The FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.
The test provides results for therapeutic drug monitoring in less than five minutes using fingerpick blood.
The loan will help fund Scope's development of its PCR One point-of-care molecular diagnostic instrument and related respiratory virus panel.
The firm said the financing enables it to progress with the development of an algorithm that would help detect the most common cancers.
The company's stock will now trade on a split-adjusted basis on the Nasdaq after authorization for the split was approved by stockholders.
Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.
Under the agreement, DiaSorin will make the test, which distinguishes between viral and bacterial infections, available on its Liaison analyzer platform.
The firms settled disputes over a former distribution agreement and established a new deal for patient transfusion diagnostics, Quotient said.
The company's contract with the NIH offered $12 million total and after initial test verification, Fluidigm will receive approximately $11 million.
The test is for use with the company's Liaison MDx instrument and can be used alone or with the Simplexa COVID-19 Direct kit.
BillionToOne's test is based on the company's proprietary Sanger sequencing approach, while Sugentech's test detects antibodies against SARS-CoV-2.
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.