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The company launched a "core" service using Illumina microarray genotyping, and has plans for an expanded NGS offering with Quest Diagnostics.

While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.

The final guidance seeks to streamline the process, which has typically required separate submission processes for the drug and the device.

The system, which was launched in Europe earlier this year, helps eliminate preanalytical errors by automatically detecting patient tube parameters.

The company's Acucy Influenza A&B test detects viral nucleoprotein antigens from nasal and nasopharyngeal swabs. 

Specific Diagnostics said it plans to apply CE marking to the Reveal system next year, followed by submission to the FDA for 510(k) clearance. 

The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said. 

Of the 29 companies in the index, 16 firms' share prices retreated while the other 13 saw their stock prices rise month over month.

The organizations noted in a letter to HHS and FDA that they "believe the agency's actions may in fact inflict greater harm on patients and impede innovation."

The device is intended for preparation of stool samples and use with Buhlmann's Fcal Turbo calprotectin test.

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