With the new clearance, DiaSorin's test can be run on genital swabs, and all cutaneous and mucocutaneous swab samples, as well as CSF samples.
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.
Lawmakers have asked four direct-to-consumer genetic testing companies to explain their privacy policies and security measures, according to Stat News.
The Trump Administration has proposed a plan to reorganize the federal government, the Washington Post reports.
In Science this week: genetic overlap among many psychiatric disorders, and more.
The Economist writes that an increasing number of scientific journals don't do peer review.