Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy.
The test is Micronics’ first to receive FDA clearance, and the company is pursuing CE marking for it and the PanNAT system.
The ResistancePlus MG Positive Control kit was listed with the FDA for sale in the US, where it will be sold through SpeeDx's US entity.
The investment bank gave the company's stock an Outperform rating with a target price of $90 per share.
The test reduces hands-on time by enabling labs to simultaneously assess Factor II and Factor V gene mutations from a single patient sample, Roche said.
The test runs on the BD Viper LT system and detects 14 high-risk types of human papilloma virus.
The Sentosa SA201 HSV-1/2 PCR test detects herpes virus DNA from oral or anal skin lesions in symptomatic patients.
Centogene opened a Boston office in December and plans to open a lab there in a few months as it awaits an FDA decision on its clinical tool.
Executives at two commercial payors said they'd follow CMS' lead when it comes to patients covered under Medicare but beyond that their support for the agency's policy is less clear.
An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.
The Wall Street Journal looks into FamilyTreeDNA's handling of genetic genealogy searches by law enforcement.
In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.
MIT's Technology Review reports that researchers hope to develop a CRISPR-based pain therapy.
In Science this week: atlas of malaria parasites' gene expression across their life cycles, and more.