Navigation Links
Agendia Supports Genentech's Citizen's Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards

HUNTINGTON BEACH, California, and AMSTERDAM, May 28 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, today announced its strong support of Genentech's Citizen's Petition. Filed on December 5, 2008, Docket No. FDA-2008-P-0638-0001/CP petitions that all in vitro diagnostic tests be held to one set of scientific and regulatory standards. In response, on May 28, 2009, Agendia formally submitted a letter of support to the U.S. Food and Drug Administration (FDA). The Genentech petition and other documents submitted in support of and in opposition to the petition can be accessed here: 2008-P-0638

(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)

Agendia's leading product, MammaPrint(R), is commercialized globally to aid physicians in making informed treatment decisions for breast cancer patients. In 2007, MammaPrint became the first in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. FDA clearance requires clinical and analytical validation and reporting systems that ensure patient safety issues are addressed. Manufacturers of breast cancer recurrence assays that are not FDA-cleared operate solely under CLIA regulations and are free to make claims of superiority, safety or otherwise, regardless of scientific and clinical evidence. Consequently, physicians do not have the scientific and clinical data to evaluate some of the most promising advances in molecular diagnostics. The FDA deemed the need for regulation of the utmost importance and introduced the IVDMIA guidelines in 2006. Formal regulatory decisions on the matter have since been stagnant, however. Agendia believes this has led to a precarious situation that raises patient safety and treatment decision concerns and creates an uneven playing field for providers of molecular diagnostic services.

Genentech's Citizen's Petition to the FDA is an important step in the movement towards in vitro diagnostic regulatory standardization. Agendia commends Genentech for making clinical validation, regulation and patient safety a top priority and looks forward to remaining engaged with key decision makers on this important healthcare issue.

For more information, please visit

SOURCE Agendia B.V.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Agendia BV Appoints Mr. Hessel Lindenbergh as Chairman of its Supervisory Board
2. Agendia Joins the Personalized Medicine Coalition (PMC)
3. Agendia Acquires Rights to the Discovery of a Major Drug Resistance Mechanism in Breast Cancer Potentially Leading to a Herceptin(R) Sensitivity Test
4. Agendia BV Announces That its Chief Research Officer Laura van t Veer has Received a 2007 Breast Cancer Research Foundation Award
5. Agendia BV Appoints Clinical and Scientific Advisory Board
6. Agendia and Agilent Announce Plans to Jointly Develop New Diagnostic Tests, Extend Supply Agreement
7. Agendias MammaPrint(R) Receives Prestigious Award From Dutch Innovation Platform
8. Agendia and Ferrer Announce Exclusive Agreement for Sales of Cancer Diagnostic Services in Four Major European Markets
9. Agendia Appoints New Chief Financial Officer
10. Agendias Breast Cancer Test MammaPrint(R) Standard of Care at Netherlands Cancer Institute - AVL
11. Agendia Appoints VP of Business Development
Post Your Comments:
(Date:10/13/2015)...  Cepheid (Nasdaq: CPHD ) today announced preliminary ... --> --> Based on ... quarter of 2015 is expected to be approximately $126.5 ... be approximately $(0.32) for the third quarter.  Based on ... for the third quarter of 2015 is expected to ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... ... for production, culture, and assessment of organotypic 3D cell culture models, has launched ... for contract screening in their patent-pending 3D InSightâ„¢ Human Liver Microtissues. The ...
(Date:10/13/2015)... Research and Markets( ) has announced ... for Bone Morphogenetic Protein Growth Factor Therapy - 16 ... --> --> Bone morphogenetic proteins ... bone after a fracture. In nature, these proteins have ... of the skeleton. There are twenty different BMPs that ...
(Date:10/13/2015)... ALBANY, New York , October 13, 2015 ... Share, Growth, Trends, and Forecast 2015 - 2023 " ... bn in 2014 and is anticipated to reach US$7.59 bn by ... from 2015 to 2023. --> " Microbiology Culture ... 2015 - 2023 " , the global microbiology ...
Breaking Biology Technology:
(Date:10/8/2015)... SAN JOSE, Calif. , Oct. 8, 2015 ... leading developer of human interface solutions, announced today ... first quarter of fiscal 2016 on Thursday, October ... company will host a corresponding conference call for ... p.m. ET), during which management may discuss forward-looking ...
(Date:10/6/2015)... 6, 2015 Track Group, Inc. (OTCQX: TRCK), ... has signed a contract with the Virginia Department of ... range of sentences under the Department,s oversight. ... "This contract with the Virginia DOC will expand our ... advances our position as a trusted leader in offender ...
(Date:9/30/2015)... Sept. 30, 2015  With nearly 300,000 Americans living ... new SCIs estimated to reach 12,500 annually, the role ... Resource Services for Independent Living (SCRS-IL) is increasingly ... California opening doors to independence for ... and services, notably assistive technology services and education. ...
Breaking Biology News(10 mins):