Close Menu

Breaking News

Still early in its clinical testing operations, the company shrank its net loss to $6.3 million or $.09 per share during the quarter.

The FDA said tests with strong performance in symptomatic patients can be authorized for over-the-counter use without first being validated in asymptomatic individuals.

The startup will use the funds to support R&D and to launch its Qsant urine test to help determine if a patient's body is rejecting a kidney transplant.

The survey found analysis, interpretation, and reporting requirements can take more than six hours per test but that reimbursement for tests doesn't account for this work.

The partners will assess Stella's assay by quantifying proto-oncogenes in Barrett's esophagus tissue that have progressed to cancer, and those that have not.

The firm said it has developed a POC test that uses a biomarker for HPV16, which is responsible for more than 90 percent of all HPV-related head and neck tumors.

The winning teams used a variety of technologies for their tests, including rapid PCR, antigens, point-of-care LAMP, olfaction, and breathalyzers.

The deal to create a comprehensive genomic profiling test for Illumina's NextSeq 550Dx comes months after the instrument received regulatory approval in China.

NeoGenomics will use its gene fusion panels to identify patients with solid tumors and an NRG1 fusion who might qualify for Elevation's Phase II CRESTONE study. 

The lab will perform DNA and RNA sequencing as well as well as liquid biopsy analyses to advance precision oncology in New Jersey and the East Coast.

The UK government said that each firm will aim to manufacture approximately 2 million tests per week by the end of May to help scale up its rapid testing program.

BioMark Diagnostics has been collaborating on the test with the Metabolomics Innovation Centre at the University of Alberta since early 2015.

The bill would provide $4.5 billion from 2022 to 2026 to support clinical lab infrastructure to improve SARS-CoV-2 and COVID-19 testing and response.

The firm said it will use the financing to develop and commercialize its immune response gene-expression diagnostic tests.

The company said clinical lab revenues rose 92 percent during the quarter, driven by significant volume and pricing growth due to an improved product mix.

Boston-based Variantyx will expand its whole-genome sequencing testing method to oncology from rare inherited and neurological disorders.

The firm said that a Series A round of financing will enable it to begin marketing its Urodiag test for recurrent bladder cancer.

The firm said that Microbix COVID-variant quality assessment products will monitor the workflow accuracy and laboratory testing performance of Seegene variant assays.

According to the company, the test is 98 percent sensitive and 100 percent specific for detecting SARS-CoV-2, in both symptomatic and asymptomatic individuals.

The company signed a non-exclusive license for Zora's ceramide markers and plans to launch a test based on the markers as early as next year.

Under the acquisition agreement, expected to close in Q2, Roche will acquire all outstanding shares of GenMark's common stock for $24.05 per share.

The silver amplification immunochromatography-based test is designed to detect SARS-CoV-2 antigens nasopharyngeal swab samples within 13 minutes.

The company has also received Emergency Use Authorization from the US Food and Drug Administration for a CE-marked SARS-CoV-2 antibody assay.

The issues may relate to sporadically leaking assay tubes causing an obstructed optical path in the Cobas Liat analyzer or abnormal PCR cycling in the reaction tubes.

The company is focused on developing and commercializing therapeutic and companion diagnostic products to treat inflammatory bowel disease.

Pages