The agency approved Novartis' Rydapt for AML patients with FLT3 mutations, who will be identified by Invivoscribe's LeukoStrat CDx.
Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the FDA originally approved in 2014.
The company presented data demonstrating that ADHD patients with mutations in nine genes had a clinically meaningful and statistically significant response to AEVI-001.
Thermo is launching a program to develop its NGS Oncomine products into companion diagnostics, with the University Hospital Basel as its first partner.
CSO Phil Stephens said the firm is finding specific genomic alterations that appear to affect sensitivity to immunotherapies, as it also advances overall mutation burden testing.
BeiGene will use Myriad's myChoice HRD and BRACAnalysis CDx in the development program for its investigational PARP inhibitor BGB-290.
The firm's treatments are based on stimulating the innate immune system with drugs made from inactivated bacteria to restore normal immune function.
The assay can be used to identify patients suitable for treatment with ALK-targeted therapeutics such as Pfizer's Xalkori.
The companies are aiming to develop and commercialize a test to identify patients likely to respond to Loxo's cancer drug larotrectinib.
The study compared five methods, including three based on Roche test kits and reagents, and suggested that a multiplexed test may be best to avoid false-negative results.
The company is developing a non-invasive test that analyzes only a small area of the genome to infer overall tumor mutational load to help guide immunotherapy use.
The firm will apply the proceeds towards an early-stage clinical trial of a precision colorectal cancer vaccine.
The firm's ROS1 gene fusion kit was approved as a companion diagnostic for Pfizer's Xalkori.
MDx product sales for diagnosing and monitoring hepatitis and HIV load, and screening HPV, grew 7 percent year over year.
The European Commission has now approved the anti-PD-1 therapy Keytruda, and the Dako test with it, as a first-line treatment for non-small cell lung cancer.
The two companies are expanding a long-term collaboration to include development and commercialization of assays for the Applied Biosystems 3500Dx system.
The results of the Harvard-led study suggest that the immune system struggles to infiltrate and attack tumors with more aneuploidy.
There was a lot of growth in the precision medicine field in the past year, and some experts believe the FDA's decision to hold off on regulating LDTs could spur more innovation.
The partners will use population genomics to discover and develop novel therapeutics and companion diagnostics for a range of chronic diseases.
BMS has provided funding to the diagnostic company to support build-out of its new lab and development of its platform, which they hope can identify new biomarkers for Opdivo.
Oxford researchers are turning to virtual reality to visualize genes and regulatory elements, Phys.org says.
The Jackson Laboratory has filed a complaint accusing Nanjing University of breeding and re-selling its mouse models, the Hartford Courant reports.
In Science this week: neutrophils rely on microRNA to protect against lung inflammation, and more.
China is moving forward with plans to sequence a million citizens, the Wall Street Journal reports.