• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Targeted Molecular Diagnostics Announces New EGFR Testing Program Improves Patient Access to Targeted Cancer Treatment

Posted on: Thursday, 6 July 2006, 12:00 CDT

Targeted Molecular Diagnostics, LLC (TMD) announces the publication of clinical data from their Targeted Diagnostics Advocacy Program (tdap(TM)) at the 42nd annual meeting of the American Society for Clinical Oncology (ASCO) in Atlanta, GA. During the poster presentation session on June 5th, TMD presented data from their ongoing tdap(TM) study - Heterogeneity of Epidermal Growth Factor Receptor (EGFR) Expression and Variation in Immunohistochemistry (IHC) Testing May Affect Access to EGFR-Targeted Therapy in Patients with Advanced Colorectal Cancer (CRC). The study showed that patient access to potentially beneficial therapy is severely compromised by variation in testing procedures between laboratories and that the tdap(TM) has improved access through the assessment of multiple tumor specimens and standardization in a central laboratory. Of 245 U.S. study patients previously reported clinically to be EGFR-negative and inappropriate for treatment, 68% (167/245) were found to be EGFR-positive when re-tested through the tdap(TM).

"The tdap(TM) program has increased access to EGFR-targeted therapy for hundreds of cancer patients nationwide and can potentially benefit oncologists dealing with reimbursement issues. Moreover, it can provide valuable education and support for pathologists challenged with EGFR testing difficulties. This program is a first in oncology and may provide guidance for future diagnostic and therapeutic development," states Dr. A. David McCollum, noted GI Cancer Researcher and attending physician at Baylor Sammons Cancer Center and US Oncology.

The EGFR IHC test is FDA-approved as an aid in selecting patients for cetuximab (Erbitux, ImClone Systems) therapy(1)(TM) and is also in use to evaluate patients in phase 3 trials of panitumumab (Amgen)(2).

The Targeted Diagnostic Advocacy Program (tdap(TM)) provides EGFR testing and education to clinicians and hospital laboratories through TMD. Also as part of the program, TMD offers physicians the option to test or re-test patients in a standardized central laboratory.

Targeted Molecular Diagnostics, LLC (www.tmdlab.com) is focused on the development and performance of targeted cancer diagnostic tests to enable personalized cancer treatment. TMD has pioneered the use of biomarkers to advance clinical trials for biopharmaceutical companies and is involved in numerous ongoing studies and clinical programs. The company was founded in 2004, is privately held, and has clinical and research laboratories located in the Chicago suburb of Westmont, IL.

(1)EGFR pharmDx package insert. Dako North America, Inc, Carpinteria, CA.

(2)Peeters M, et al. A phase III, multicenter, randomized controlled trial of panitumumab plus best supportive care (BSC) versus BSC alone in patients with metastatic colorectal cancer. AACR Annual Meeting, 2006.

Source: Business Wire

More News in this Category