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
Date:5/28/2009

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: http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA- 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 http://www.agendia.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016   Boston Biomedical ... novel compounds designed to target cancer stemness pathways, ... been granted Orphan Drug Designation from the U.S. ... of gastric cancer, including gastroesophageal junction (GEJ) cancer. ... designed to inhibit cancer stemness pathways by targeting ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... (Yeast and Mold) microbial test has received AOAC Research Institute approval 061601. , ... tests introduced last year,” stated Bob Salter, Vice President of Regulatory and Industrial ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the ... the Supplyframe Design Lab . Located in Pasadena, Calif., the Design Lab’s ... how hardware projects are designed, built and brought to market. , The Design ...
(Date:6/23/2016)... NEWPORT BEACH, Calif. , June 23, 2016 /PRNewswire/ ... offering new biological discoveries to the medical community, has ... and co-founder Matthew Nunez . "We ... provide us with the capital we need to meet ... funding will essentially provide us the runway to complete ...
Breaking Biology Technology:
(Date:4/13/2016)... physicians supporting Medicaid patients in Central Florida ... telehealth thanks to a new partnership with higi.   ... can routinely track key health measurements, such as blood ... they opt in, share them with IMPOWER clinicians through ... location at no cost. By leveraging this data, IMPOWER ...
(Date:3/29/2016)... , March 29, 2016 LegacyXChange, ... LegacyXChange "LEGX" and SelectaDNA/CSI Protect are pleased to announce ... used in a variety of writing instruments, ensuring athletes ... originally created collectibles from athletes on LegacyXChange will be ... of the DNA. Bill Bollander , ...
(Date:3/22/2016)... Ontario , PROVO and ... Newborn Screening Ontario (NSO), which operates the ... for molecular testing, and Tute Genomics and UNIConnect, ... management technology respectively, today announced the launch of a ... next-generation sequencing (NGS) testing panel. NSO ...
Breaking Biology News(10 mins):