The company plans to continue to validate the liquid biopsy system for use in cancer diagnostics, therapy management, and patient monitoring.
As part of the approval, DermTech will market and sell the pigmented lesions assay in Canada, while samples will be processed at the company's lab in California.
The test, which also is FDA-approved, can be used to identify best responders to three non-small cell lung cancer treatment regimens.
In two documents FDA discusses the development of drugs for molecular indications and investigational device exemption requirements for IVDs in drug trials.
The suit filed against the acting HHS secretary alleges that a flawed data collection process failed to establish market-based rates.
The test runs on the GeneSTAT system, and has demonstrated 100 percent sensitivity, 99.6 percent specificity, and 100 percent reproducibility.
The new assay — the third FDA cleared respiratory test that runs on the Panther Fusion System — detects adenovirus, human metapneumovirus, and rhinovirus.
The authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.
The test is designed to detect 14 of the most prevalent mutations in the gene responsible for the disease.
Interpace can now offer the new service alone or in conjunction with ThyGenX next-generation sequencing oncogene panel in New York.
The robotic microbial DNA isolation and direct PCR test is designed for routine bacterial and fungal pathogen diagnosis.
The approved Ventana ALK (D5F3) immunohistochemistry CDx is available for use on the Roche BenchMark XT or BenchMark Ultra IHC/ISH slide staining systems.
This is the first US Food and Drug Administration approval for a drug based solely on data from a basket study.
According to the Federal Register notice, after a first time FDA marketing authorization, manufacturers can commercialize new GHR tests without additional review.
The assay is part of a respiratory testing menu that includes assays for Bordetella and Flu A/B & RSV, and NxTAG and Verigene respiratory pathogen panels.
The multiplexed assay is the second available on the Panther Fusion system and the FDA is reviewing a third, the Panther Fusion AdV/hMPV/RV assay.
The test is designed to detect and differentiate herpes simplex virus types 1 and 2, Treponema pallidum, and varicella-zoster virus.
If approved, the companion test can be used to identify which metastatic breast cancer patients have mutations in BRCA1/2 genes and are likely to respond to Lynparza.
The test is performed on the company's AmpiProbe platform, and the approval expands Enzo's offering of infectious disease tests in New York.
The kits cover the primary genetic targets currently used for assessing the compatibility of hematopoietic cell donors with recipients.
Technology Review reports that 2017 was the year of consumer genetic testing and that it could spur new analysis companies.
A phylogenetic analysis indicates two venomous Australian spiders are more closely related than thought, the International Business Times reports.
In Science this week: CRISPR-based approach for recording cellular events, and more.
A new company says it will analyze customers' genes to find them a suitable date, though Smithsonian magazine says the science behind it might be shaky.