Biotechnology Healthcare - September/October 2008 - (Page 23) HER2 How Do TESTS: We Choose? For women with breast cancer, a faulty test defining their HER2 status can alter their treatment course while adding to costs. Getting it right has huge potential for not only saving payers their money, but also saving women their lives. BY BOB CARLSON, MHA Senior Contributing Editor W hen my sister was diagnosed with breast cancer in 2006, my job was to get answers to such questions as “How reliable is an immunohistochemical HER2 test?” The breast oncology nurse at the Indiana University Medical Group who took my call didn’t even ask about my sister’s immunohistochemical (IHC) HER2 test results. Sounding very much like she had answered this question before, she told me, “The test needs to be confirmed by a FISH test,” and went on to explain that fluorescence in situ hybridization (FISH) was the definitive HER2 test. My sister eventually decided on a double mastectomy and reconstructive surgery, but that conversation with the oncology nurse came back to me when I read a 2007 New York Times article titled “Cancer Drug May Elude Many Women Who Need It” (Pollack 2007). The article reported on two studies that called into question the reliability of both IHC and FISH tests for overexpression of the HER2 “Many, many variables can influence the result” of an immunohistochemistry HER2 assay, says Soonmyung Paik, MD, the principal investigator of the National Surgical Adjuvant Breast and Bowel Project Trial B-31. SEPTEMBER/OCTOBER 2008 · BIOTECHNOLOGY HEALTHCARE 23
Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - September/October 2008 Biotechnology Healthcare - September/October 2008 Openers Editorial/David B. Nash, MD, MBA Contents At a Glance: Multiple Sclerosis Drug Track Personalized Medicine Healthcare Reform’s Effects on Biologic Access Breast Cancer Status Testing: A Crapshoot With Deadly Odds Trends, Issues, and Perspectives In the Management of MS So High-Tech, Yet So Simple The Evolution of Ascertaining the Value Proposition Specialty Pharmacy Employer to Employer Health Plan Confidential Trends Biotechnology Healthcare - September/October 2008 Biotechnology Healthcare - September/October 2008 - Biotechnology Healthcare - September/October 2008 (Page CoverA) Biotechnology Healthcare - September/October 2008 - Biotechnology Healthcare - September/October 2008 (Page CoverB) Biotechnology Healthcare - September/October 2008 - Biotechnology Healthcare - September/October 2008 (Page CoverC) Biotechnology Healthcare - September/October 2008 - Biotechnology Healthcare - September/October 2008 (Page CoverD) Biotechnology Healthcare - September/October 2008 - Biotechnology Healthcare - September/October 2008 (Page 1) Biotechnology Healthcare - September/October 2008 - Openers (Page 2) Biotechnology Healthcare - September/October 2008 - Editorial/David B. Nash, MD, MBA (Page 3) Biotechnology Healthcare - September/October 2008 - Contents (Page 4) Biotechnology Healthcare - September/October 2008 - Contents (Page 5) Biotechnology Healthcare - September/October 2008 - At a Glance: Multiple Sclerosis (Page 6) Biotechnology Healthcare - September/October 2008 - At a Glance: Multiple Sclerosis (Page 7) Biotechnology Healthcare - September/October 2008 - Drug Track (Page 8) Biotechnology Healthcare - September/October 2008 - Drug Track (Page 9) Biotechnology Healthcare - September/October 2008 - Drug Track (Page 10) Biotechnology Healthcare - September/October 2008 - Personalized Medicine (Page 11) Biotechnology Healthcare - September/October 2008 - Personalized Medicine (Page 12) Biotechnology Healthcare - September/October 2008 - Personalized Medicine (Page 13) Biotechnology Healthcare - September/October 2008 - Personalized Medicine (Page 14) Biotechnology Healthcare - September/October 2008 - Personalized Medicine (Page 15) Biotechnology Healthcare - September/October 2008 - Personalized Medicine (Page 16) Biotechnology Healthcare - September/October 2008 - Personalized Medicine (Page 17) Biotechnology Healthcare - September/October 2008 - Healthcare Reform’s Effects on Biologic Access (Page 18) Biotechnology Healthcare - September/October 2008 - Healthcare Reform’s Effects on Biologic Access (Page 19) Biotechnology Healthcare - September/October 2008 - Healthcare Reform’s Effects on Biologic Access (Page 20) Biotechnology Healthcare - September/October 2008 - Healthcare Reform’s Effects on Biologic Access (Page 21) Biotechnology Healthcare - September/October 2008 - Healthcare Reform’s Effects on Biologic Access (Page 22) Biotechnology Healthcare - September/October 2008 - Breast Cancer Status Testing: A Crapshoot With Deadly Odds (Page 23) Biotechnology Healthcare - September/October 2008 - Breast Cancer Status Testing: A Crapshoot With Deadly Odds (Page 24) Biotechnology Healthcare - September/October 2008 - Breast Cancer Status Testing: A Crapshoot With Deadly Odds (Page 25) Biotechnology Healthcare - September/October 2008 - Breast Cancer Status Testing: A Crapshoot With Deadly Odds (Page 26) Biotechnology Healthcare - September/October 2008 - Breast Cancer Status Testing: A Crapshoot With Deadly Odds (Page 27) Biotechnology Healthcare - September/October 2008 - Breast Cancer Status Testing: A Crapshoot With Deadly Odds (Page 28) Biotechnology Healthcare - September/October 2008 - Trends, Issues, and Perspectives In the Management of MS (Page 29) Biotechnology Healthcare - September/October 2008 - Trends, Issues, and Perspectives In the Management of MS (Page 30) Biotechnology Healthcare - September/October 2008 - Trends, Issues, and Perspectives In the Management of MS (Page 31) Biotechnology Healthcare - September/October 2008 - Trends, Issues, and Perspectives In the Management of MS (Page 32) Biotechnology Healthcare - September/October 2008 - Trends, Issues, and Perspectives In the Management of MS (Page 33) Biotechnology Healthcare - September/October 2008 - Trends, Issues, and Perspectives In the Management of MS (Page 34) Biotechnology Healthcare - September/October 2008 - So High-Tech, Yet So Simple (Page 35) Biotechnology Healthcare - September/October 2008 - So High-Tech, Yet So Simple (Page 36) Biotechnology Healthcare - September/October 2008 - So High-Tech, Yet So Simple (Page 37) Biotechnology Healthcare - September/October 2008 - So High-Tech, Yet So Simple (Page 38) Biotechnology Healthcare - September/October 2008 - The Evolution of Ascertaining the Value Proposition (Page 39) Biotechnology Healthcare - September/October 2008 - The Evolution of Ascertaining the Value Proposition (Page 40) Biotechnology Healthcare - September/October 2008 - The Evolution of Ascertaining the Value Proposition (Page 41) Biotechnology Healthcare - September/October 2008 - The Evolution of Ascertaining the Value Proposition (Page 42) Biotechnology Healthcare - September/October 2008 - Specialty Pharmacy (Page 43) Biotechnology Healthcare - September/October 2008 - Specialty Pharmacy (Page 44) Biotechnology Healthcare - September/October 2008 - Employer to Employer (Page 45) Biotechnology Healthcare - September/October 2008 - Employer to Employer (Page 46) Biotechnology Healthcare - September/October 2008 - Health Plan Confidential (Page 47) Biotechnology Healthcare - September/October 2008 - Health Plan Confidential (Page 48) Biotechnology Healthcare - September/October 2008 - Trends (Page 49)
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