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Researchers concluded that there has been significant expansion of coverage for ctDNA assays over the past four years, but policies remain very heterogeneous and often limited.
The companies will work together to bring Guardant360 through regulatory approval and commercialize it as a CDx for Janssen's amivantamab.
Thermo Fisher has also applied to the Japanese Ministry of Health, Labor, and Welfare to expand the use of the Oncomine Dx Target test in Japan.
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.
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.
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.
Lexent's technology integrates low-pass whole-genome sequencing, fragmentomics, and DNA methylation to detect early stage disease.
The firm initially plans to apply the method, which measures the size of specific macrophages in blood, to predict lung cancer immunotherapy response.
Burning Rock also said it will continue to develop companion diagnostics-related products based on next-generation sequencing technology.
The firm's Inify Prostate Screening product presorts slides in a worst-first order, allowing pathologists to work immediately on the most relevant areas.
The firm used the new loan to pay off an older $7.0 million loan and a $3.0 million promissory note held by Qiagen North American Holdings.
For the three months ended March 31, the firm reported revenues of $9.2 million, up from $6.0 million in the year-ago quarter and beating the consensus Wall Street estimate of $8.9 million.
The algorithm provides automated assessments of objective and reproducible scanned slide images that can help with diagnosis and targeted treatment options.
The assay will identify patients with mutations in HER2 who may be eligible for treatment with a HER2-directed antibody-drug-conjugate developed by Daiichi.
The companies are developing a lung cancer liquid biopsy assay that will run on desktop sequencers, with plans to apply for regulatory clearance in China.
BioSkryb will now have an exclusive global license for clinical applications of primary template directed amplification technology.
The company sells a number of next-generation sequencing-based tissue and liquid biopsy tests for cancer therapy selection to the Chinese market.
By combining with ArcherDX, Invitae will gain tumor profiling and liquid biopsy technologies for predicting and monitoring therapeutic response.