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

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In PNAS this week: retinitis pigmentosa gene therapy, role of microbiome in growth stunting, and more.

The US National Institutes of Health and the Food and Drug Administration have proposed changing gene therapy oversight, the Associated Press reports.

Nature News reports that the Salk Institute has asked for the scope of a gender discrimination lawsuit brought against it to be narrowed.

CNBC reports that the sequencing startup Veritas aims to sequence individuals who fall at extremes.

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This webinar offers a look at how an advanced genetics laboratory implemented and validated a commercial bioinformatics system to help scale its operations.

Sep
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Horizon Discovery

In this webinar, Kevin Balbi, head of bioinformatics at Sarah Cannon Molecular Diagnostics, will discuss the validation of targeted sequencing panels on the Ion Torrent platform using Horizon Discovery’s Tru-Q controls. 

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Roche

In the last few years several molecular testing methodologies — such as immunohistochemistry, PCR, and sequencing — have been approved by the US Food and Drug Administration to aid in the management of patients with lung cancer.