Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Gene amplification test comparison to "gold standard" to be discussed Feb. 11 at joint panel meeting.

This article was originally published in The Gray Sheet

Executive Summary

GENE AMPLIFICATION TEST COMPARISON TO "GOLD STANDARD" IN PREMARKET SUBMISSIONS is slated for discussion Feb. 11 at a joint meeting of FDA's four in vitro diagnostics advisory panels. The Microbiology Devices Panel, Clinical Chemistry and Clinical Toxicology Devices Panel, Hematology and Pathology Devices Panel, and Immunology Devices Panel all are gathering at FDA device center offices in Rockville, Maryland to provide input on "how the FDA should proceed" in the area of resolution of discrepant results "when new technology such as nucleic acid amplification is perceived to be more accurate than the reference or "gold standard" methods," according to a recent Federal Register announcement of the meeting.

You may also be interested in...

HHS Policy Move Means FDA Must Publish More Documentation To Support Rulemaking Decisions

To be more transparent and allow more public discourse, the HHS now requires all its agencies to publish documents it uses to rationalize proposed rules and demonstration projects.

Dr Reddy's Strengthens Russian OTC Portfolio Through Glenmark Deal

Dr Reddy's is poised to expand its OTC offering in Russia and certain CIS countries by snapping up a basket of allergy brands from India's Glenmark.

Moderna Files COVID-19 Vaccine After Second Impressive Read-Out

Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts