The in vitro diagnostic uses next-generation sequencing to detect clinically actionable genetic variants to guide therapy selection for cancer patients.
A European study, published today in NEJM, used a POC, PCR-based system to perform CYP2C19 genotyping to guide platelet inhibitor therapy.
The company sold nearly twice as many tests as in Q2 last year, with clinical test revenue more than doubling and total revenue reaching $54 million for the quarter.
Biocartis' Idylla called some colorectal cancer samples negative that Sysmex Inostics's OncoBEAM called positive, but the clinical implications may be complex.
Practical, technological, and systemic challenges are putting pathologists in tough positions, facing competing demands for molecular analysis of limited biological samples.
Meeting presentations supported tweaking the clinical interpretation of Genomic Health's Oncotype DX and bolstered Biotheranostics' Breast Cancer Index.
The company plans to use the funds to support further commercialization of its tumor tissue sequencing test, the Paradigm Cancer Diagnostic.
The test relies on a signature that Almac developed for stratifying breast cancer patients, but which, as the researchers showed, can be used in other cancers as well.
Investigators from a variety of clinical sites found that the company's liquid biopsy test was more successful in finding actionable mutations in patients than tumor tissue.
Last year, the Gottlieb-led FDA approved 25 new molecularly-defined drugs and expanded indications compared to 19 in the prior year, and issued a slew of guidelines important for the personalized medicine field.