Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Multi-Gene Expression Test Helps Rule Out Thyroid Surgery In Large Study

This article was originally published in The Gray Sheet

Executive Summary

Presented and published study provides strong validation for use of Veracyte’s Afirma gene expression classifier in assessing patients with potential thyroid cancer.

You may also be interested in...



Utility Before Profitability: The Evolving Evidence Paradigm For Molecular Diagnostics

The standards needed for reimbursement of molecular diagnostics are changing – especially with respect to genomics-based tests, with their potential impact on public health with respect to screening, prevention, and measuring response to treatment, as well as cost. As the complexity of the assay development and launch process has grown, so too has the emphasis on evidence and clinical effectiveness, as well as the importance of finding better ways to align test coding and reimbursement with clinical value. But a lack of coordination across agencies and commercial players makes an assessment of the impact of any changes on evidence demands problematic.

Veracyte Meets New Medicare Coverage Mandate For Molecular Dx

Veracyte announced a positive coverage policy from Palmetto GBA Jan. 9 for its Afirma multi-gene expression classifier test, one of the first to go through the Medicare contractor’s new requirements.

MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In

The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT031358

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

Cancel