FDA Submission: Page 2

FDA airs 'to do' list for devices in 2020

The agency's Center for Devices and Radiological Health (CDRH) released its list of planned new guidance documents, with some prioritized for next year, along with a request for input on whether certain older guidance documents should be changed or withdrawn.

October 13, 2019

ACLA blasts FDA's 'troubling actions' on pharmacogenetic tests

ACLA President Julie Khani spelled out the association's concerns and requested a meeting in a September 18 letter to FDA Acting Commissioner Dr. Ned Sharpless; Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health; and Dr. Timothy Stenzel, PhD, director of the Office of In Vitro Diagnostics and Radiological Health.

September 18, 2019

SpeeDx Mgen STI test debuts in Europe

The diagnostic test screens for Mgen as well as for resistance to the macrolide class of antibiotics, such as azithromycin, which is a first-line treatment for the infection. Cepheid will be responsible for marketing and distributing the Mgen test for use with its Flexible cartridge and GeneXpert system.

September 5, 2019

Prescient Medicine buys AutoGenomics for Infiniti test

Prescient said the acquisition will enable the company to advance the development and commercialization of AutoGenomics' Infiniti neural response panel, a diagnostic test for the identification of individuals who may be at risk for opioid use disorder. The acquisition builds on a collaboration between the firms that began in 2017.

April 23, 2019

FDA gives nod to Hologic assay for STI bacterium

Called Aptima, it is the first test to be cleared by the FDA for M. genitalium, which is associated with inflammation of the urethra (nongonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.

January 28, 2019