Navigation Links
Agendia to Provide Testimony at Public Meeting on FDA Oversight of Laboratory-Developed Tests
Date:7/15/2010

IRVINE, California, and AMSTERDAM, July 15, 2010 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, announced today that company CEO Dr. Bernhard Sixt will provide testimony at a public meeting on July 20 in Washington D.C. on the federal regulation of laboratory developed tests (LDTs). Jointly organized by the Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH), the Public Meeting on Oversight of Laboratory Developed Tests will be a forum for key stakeholders, including laboratory professionals, clinicians, patients and industry leaders, to discuss and define the issues surrounding LDT regulation which pose the greatest risk to the public health. Dr. Sixt will present in Session II, "Oversight of LDTs: Clinical Laboratory Challenges."

Since the implementation of the 1976 Medical Device Amendments, the FDA has exercised enforcement discretion over LDTs, but has not pursued active regulation of the category. However, in recent years these tests have become increasingly complex and high risk in nature, and are playing an important role in clinical decision-making. As a result, the FDA has decided that LDTs which have not been properly validated put patients at risk, and that a risk-based application of oversight for the category is appropriate.

Agendia joins the FDA among other leading organizations, including Genentech, the College of American Pathologists, and the Genetics & Public Policy Center at Johns Hopkins University, in calling for a tiered risk-based approach to the regulation of LDTs. As the nation's leading authority for patient safety, Agendia believes that only the FDA can regulate the LDT category in a uniform and unbiased manner to ensure that all claims are validated, data is accurate and post-market surveillance is in place. Moreover, Agendia believes that holding the LDT category to the rigors of FDA scrutiny will inspire greater confidence among investors to enter this emerging market, foster a level playing field among molecular diagnostics companies and encourage the best technology to come to the fore in personalized medicine.

As the developer of the first and only FDA-cleared breast cancer recurrence test, MammaPrint, Agendia has led by example in the molecular diagnostics industry by embarking on a path of regulatory compliance. Agendia believes that patients and physicians deserve to be fully informed about the benefits and risks of medical diagnostics, and that all companies developing these devices should be held accountable for the claims and safety of their tests.

The FDA will collect and review all comments and information presented at this public meeting towards the development of a draft oversight framework for public comment. The meeting will be held on July 19 (8:00 a.m. to 5:00 p.m.) and July 20 (8:00 a.m. to 5:30 p.m.) at The Marriott Inn and Conference Center, University of Maryland University College.


'/>"/>
SOURCE Agendia B.V.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Agendia to Play Pivotal Role in ISPY-2 Trial for Breast Cancer
2. FDA Broadens Clearance for Agendias MammaPrint(R)
3. /C O R R E C T I O N -- Agendia B.V./
4. Agendias Breast Cancer Recurrence Test MammaPrint Included in International St. Gallen Expert Consensus Recommendations
5. Agendias Breast Cancer Test MammaPrint(R) Identifies New Subset of Low Risk HER2+ Patients
6. Agendias MammaPrint(R) Predicts Response to Neoadjuvant Chemotherapy in Breast Cancer
7. Agendia Supports High Profile CME Symposium and Presents Compelling Data at the 2008 San Antonio Breast Cancer Symposium
8. Agendias MammaPrint(R) Included in 2008 Dutch Institute for Healthcare Improvement CBO Guidelines
9. Agendia Launches TargetPrint(R) for Breast Cancer Patients
10. Young Innovations, Inc. Provides 2nd Quarter Conference Call Details
11. Simcere Pharmaceutical Group Provides Notice of Annual General Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/7/2017)... -- Endo International plc (NASDAQ: ENDP ) ... Joseph R. Goodwin , U.S. District Court Judge for ... , entered a case management order in MDL 2325, ... Litigation (the "MDL") that includes a provision requiring plaintiffs ... on specific causation within one hundred twenty (120) days ...
(Date:6/3/2017)... 2017  Eli Lilly and Company (NYSE: ... the Phase 3 MONARCH 2 study showed that ... in combination with fulvestrant, significantly improved progression-free survival ... women with hormone-receptor-positive (HR+), human epidermal growth factor ... relapsed or progressed after endocrine therapy (median PFS, ...
(Date:5/30/2017)... AVIV, Israel , May 30, 2017 ... stage pharmaceutical Company specializing in the development of ... will present a company overview at three upcoming ... The 7th Annual LD Micro Invitational: ... Date:                     ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... Radabaugh & Associates, a locally ... business owners in North Central West Virginia, is embarking on a cooperative charity ... residents in the region. , The Stepping Stones organization offers a series of ...
(Date:6/22/2017)... ... 2017 , ... Plastic Surgery Associates is proud to report that founding surgeon, ... research and information firm, Castle Connolly, releases their list of the most notable and ... 3rd time that Dr. Canales has been recognized by Castle Connolly. , ...
(Date:6/22/2017)... ... June 22, 2017 , ... ... from the American Heart Association (AHA) to launch a Rheumatic Heart Disease Center, ... prevention and diagnosis of rheumatic heart disease (RHD) in high-risk, financially disadvantaged countries ...
(Date:6/22/2017)... , ... June 22, 2017 , ... ... announced today that it has received certification for ANSI/ASIS PSC.1-2012. The company’s work ... in environments where the rule of law has been degraded. The PSC.1 standard ...
(Date:6/20/2017)... ... June 20, 2017 , ... TwelveStone Health Partners, ... a Nashville-based private equity firm, has invested $3.35 million in the company. ... and Claritas Capital offers the smart money, speed to market and accountability we ...
Breaking Medicine News(10 mins):