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News and reporting on ovarian cancer.
The companies will validate and commercialize the assay as a companion diagnostic to identify best responders to Morphotek's investigational ovarian cancer treatment.
The agreement is to support the company’s analytical and preanalytical research and assist in its trials aimed at a number of cancers.
The group that advises primary care clinicians found evidence that false-positive screening results could lead to surgical interventions in asymptomatic patients.
NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.
The Korean molecular diagnostics startup is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries.
The BRCA Mastr Plus Dx assay and Mastr Reporter software identifies mutations in the coding regions of the BRCA1 and BRCA2 genes
The company plans to submit a package to the FDA by the end of this year for use of the system in metastatic breast cancer patients, and then add other cancer types in the future.
Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the FDA originally approved in 2014.
They have also developed an exosome-based test for high volume laboratory applications that was recently licensed by Exosome Diagnostics.
A pair of studies indicate the test could aid monitoring of high-risk patients, though concerns voiced by the FDA and others are still to be fully addressed.