Atossa Warned by FDA Over its MASCT Platform | GenomeWeb

NEW YORK (GenomeWeb News) – Atossa Genetics today disclosed it has been warned by the US Food and Drug Administration over its system for the analysis of nipple aspirate fluid.

In a document filed with the US Securities and Exchange Commission, Atossa said that it received a warning letter from FDA regarding the system called Mammary Aspirate Specimen Cytology Test System, or MASCT, on Feb. 21.

FDA alleges in its warning that after MASCT was cleared by FDA, Atossa made changes to the platform that requires submission of an additional 510(k) notification, Atossa said

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In Nucleic Acids Research this week: personal genome approach to RNA-seq read alignment, hematopoietic Systems Biology Repository, and more.

A man is using DNA evidence to argue that he is the rightful heir to the baronetcy of Stichill, the Guardian reports.

As part of an effort to get a diverse group of people to donate their DNA for research, some blood donors in the San Diego area will get their genomes sequenced, according to KPBS.

The comment period on the Department of Health and Human Services' proposal to alter the Common Rule has been extended.