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The latest Emergency Use Authorization is for an ELISA-based test for detecting immunoglobulin M antibodies against SARS-CoV-2 in human serum.
Yale researchers said that they anticipate their RNA extraction-free saliva assay will make testing more scalable, affordable, and available to the public.
Investors in the company, formerly known as Vermillion, have agreed to purchase $11 million in unregistered common stock at a price of $3.50 per share.
The company recently presented results from its Aurora assay for multi-cancer screening and plans to launch a $100 test for the US and Chinese markets.
The Lexington, Massachusetts-based company has launched a two-hour SARS-CoV-2 test on its fully-automated instrument, the T2Dx.
Developed by the Ragon Institute, the ELISA-based test measures antibodies that bind to the receptor binding domain of the SARS-CoV-2 spike protein.
OncoCyte will cease further development of a liquid biopsy test that used an immune system interrogation approach to clarify whether patients’ lung nodules are benign.
The test leverages a novel cancer biomarker that may improve the accuracy and sensitivity of noninvasive bladder cancer testing.
The tests were developed by Psomagen, Acupath Laboratories, and BioTNS, and the nasal swab self-collection kit is offered by Kroger Health.
The companies will combine the Binx io diagnostic platform with Sherlock Bio's CRISPR technology to create an easy-to-use rapid test for the point of care.
In a separate study, researchers studying the use of Oncotype DX in African-American men found it to be predictive of disease outcomes regardless of race.
Through its Access to COVID-19 Tools-Accelerator program, or ACT-A, WHO hopes to quickly identify and scale up high performing rapid antigen-based diagnostics.
Irvine, California-based Fluxergy is working with the MGB Center for COVID Innovation to evaluate the firm's research-use-only COVID-19 testing platform.
Cowen said that Hologic is on track to more than double its Panther system placements to about 500 this year, driven by SARS-CoV-2 test demand.
The firm said in an SEC document that it received an FDA warning letter in connection with the agency's requirements for its Verigene SP instrument.
Lexent's technology integrates low-pass whole-genome sequencing, fragmentomics, and DNA methylation to detect early stage disease.
The PCR-based test is based on the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.
The firm initially plans to apply the method, which measures the size of specific macrophages in blood, to predict lung cancer immunotherapy response.
The agency said that KBMO has promoted a serology test based on the use of a dried blood spot kit that it offered to send to patients' homes.
Burning Rock also said it will continue to develop companion diagnostics-related products based on next-generation sequencing technology.