American Medical Association Approves New CPT Code for Serum HER-2/neu Oncoprotein Test.

Business Editors & Health Writers

TARRYTOWN, N.Y.--(BUSINESS WIRE)--Dec. 5, 2001

First in New Class of Tests Monitors Circulating HER-2/neu Levels

to Guide Metastatic Breast Cancer Therapy

Bayer Diagnostics announced today that the American Medical Association (AMA) has approved a unique Current Procedural Terminology (CPT) code for the serum HER-2/neu oncoprotein test.

The test is the first in a new category recognizing the measurement of "oncoproteins" as critical to cancer patient treatment and overall care. The HER-2/neu oncoprotein can be elevated in the blood of women with metastatic breast cancer and changes in concentration reflect treatment progression. The blood test measures circulating HER-2/neu oncoprotein to help oncologists treat patients with metastatic breast cancer.

The CPT code, 83950 becomes effective January 1, 2002, for most health insurance programs. Additionally, the Center for Medicaid and Medicare Services (CMS) has proposed that the oncoprotein HER-2/neu serum test be reimbursed at $89.01, starting in January 2002 for Medicare.

"Assignment of the CPT code is a significant step in recognizing that serum HER-2/neu testing can be a cornerstone of metastatic breast cancer treatment management," said Dr. Walter Carney, Head of Bayer Diagnostics' Oncogene Science Group. "It is our hope that appropriate reimbursement with the CPT code will encourage clinical acceptance of serum HER-2/neu testing, ultimately saving healthcare dollars through more streamlined clinical decision-making."

As a complement to conventional tissue testing such as immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH), which can determine a woman's HER-2/neu "status," serum monitoring provides a "real time" picture of a woman's HER-2/neu levels, assisting oncologists in determining whether a particular therapy is having the desired effect on the disease.

Approximately 25% of breast cancers overexpress HER-2/neu. These tumors tend to grow faster and are generally more likely to recur than those that do not overproduce the oncoprotein. This year alone, approximately 192,200 new cases of invasive, or metastatic, breast cancer will be diagnosed.

Development and commercialization of the serum HER-2/neu oncoprotein test began in 1997 as a collaboration between Bayer Diagnostics and Oncogene Science. Today, Bayer Diagnostics' Oncogene Science Group (www.oncogene.com) functions as a specialized center of excellence focused on clinical research and development of cancer diagnostic tests based on oncogenes, tumor suppressor genes and other gene targets whose proteins are directly involved in tumor growth or metastasis. These tests are designed to aid oncologists in the confirmation, monitoring, staging, screening or prognosis of human cancer.

About CPT Codes

CPT codes provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serve as an effective means for reliable nationwide communication among physicians, patients, and third parties. CPT codes are used to report medical procedures and services under public and private health insurance programs and for administrative management purposes such as claims processing and developing guidelines for medical care review. For federal programs, January 1 of each year is generally the effective date for using the new CPT codes. The AMA prepares each annual update of proprietary CPT codes so that it is available in the late fall of each year preceding its implementation.

Third-party payors (e.g. private insurers and managed care organizations) make independent determinations on whether they will cover a particular test and may not implement new codes on the same date as Medicare. It is always best to consult with each payor or other source to determine when to begin using the new codes.

With more than 7,300 employees worldwide and 2000 sales greater than $1.8 billion, Bayer Diagnostics (www.bayerdiag.com), based in Tarrytown, New York, USA, is one of the largest diagnostic businesses in the world. The organization supports customers in 100 countries through an extensive portfolio of central, self-testing, nucleic acid and near patient care diagnostics systems and services for use in the assessment and management of health, including the areas of cardiovascular and kidney disease, oncology, virology, women's health and diabetes. Bayer Diagnostics is a part of the worldwide Bayer Group, a $29 billion international health care and chemicals group based in Leverkusen, Germany. Bayer Diagnostics' global headquarters in the United States operates as part of Bayer Corporation of Pittsburgh, a research-based company with major businesses in health care, life sciences and chemicals.