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Under the deal, the companies aim to develop a companion diagnostic for Bayer's solid tumor drug larotrectinib for the Chinese market.
At the AACR annual meeting, researchers shared detection rate data for multi-cancer screening tests from Grail and Thrive Earlier Detection.
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.
Data amassed by analytics firm Diaceutics suggests fewer patients are coming into healthcare facilities and missing the chance for diagnosis, molecular testing, and treatment.
The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.
The firm said as part of a development study it is using a gut microbiome analysis tool developed in collaboration with Thermo Fisher Scientific.
The firms will evaluate Stratafide, a pan-solid tumor diagnostic test designed to identify actionable genomic alterations in tissue or blood samples.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.
A study of both tissue and blood samples from patients in a small trial found that liquid biopsy may detect putative resistance mutations missed in tissue.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The agency recognized that having some companion tests approved for a few but not all cancer drugs with the same molecularly defined indication is not optimal for patient care.
Investigators reported on how ctDNA, measured using Natera's patient-specific Signatera assays, corresponded to a patient's disease progression and other biomarkers.
A case series in partnership with My Gene Counsel to highlight the challenges genetics professionals and oncologists are grappling with as genetic testing is increasingly used in patient care.
The diagnostic will be covered when patients are tested according to the Japanese Organization of Hereditary Breast and Ovarian Cancer's criteria.
Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.
The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 15 skipping alterations.
The companies will work together to develop a next-generation sequencing-based companion diagnostic for an undisclosed cancer therapy.
Health systems' molecular testing labs haven't had to cut back on genomic profiling for cancer patients yet but may need to accommodate COVID-19 testing if needed.
SkylineDx said that the firms will work together to develop predictive immunological signatures for BioInvent's lead therapy candidate.