bioMérieux Launches VIDAS® Free PSA rt BioMarker for Prostate Cancer

bioMérieux, a world leader in the field of in vitro diagnostics, today announced FDA approval of the VIDAS® Free Prostate Specific Antigen rt (FPSA) test to aid in the diagnosis of prostate cancer. The new test will be used in tandem with bioMérieux’s VIDAS® Total Prostate Specific Antigen (Total PSA) test, which is used to screen an asymptomatic population for the early detection of prostate cancer in combination with physical examination.

The VIDAS FREE PSA test will be used when prostate cancer is suspected and will give doctors additional information to determine if a biopsy is necessary, minimizing unnecessary invasive medical procedures. The supplementary VIDAS® Total PSA test aids in the diagnosis of prostate cancer in combination with a digital rectal examination (DRE). It can also be used to predict prognosis, and to monitor prostate cancer patients.

“About one man in six will be diagnosed with prostate cancer during his lifetime.1 We’re pleased to provide physicians with a much more complete spectrum for PSA screening and monitoring, to help diagnose and treat this pervasive cancer, ” said Herb Steward, EVP and general manager of bioMérieux North America. “VIDAS Free PSA and VIDAS Total PSA are part of an expanding range of high medical value tests we’re bringing to VIDAS users.”

In addition to prostate cancer markers, VIDAS provides a comprehensive array of other cancer markers including:

• Cancer Antigen 15-3 (CA 15-3) is used as an aid in the monitoring of patients previously diagnosed with breast cancer for disease progression or response to therapy in conjunction with other clinical methods. It can also be used as an aid in the detection of recurrence in previously treated Stage II and Stage III breast cancer patients.
• Carcinoembryonic antigen (CEA) is used as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.
• CA125 II is used as an aid in the monitoring of patients previously diagnosed with ovarian cancer for disease progression or response to therapy. It can also be used as an aid in the detection of recurrence in previously treated ovarian cancer patients.
• Alpha-Fetoprotein (AFP) is used as an aid in the management of patients with nonseminomatous testicular cancer.

NOTE: Please refer to the package inserts for complete indications, instructions for use and limitations.

References:
"The Prostate Cancer Outcomes Study: Fact Sheet," National Cancer Institute, www.cancer.gov.

About VIDAS®

With nearly 26,000 VIDAS® and its compact version mini VIDAS systems (23,000 used for clinical applications and 3,000 for industrial applications), bioMérieux has the second largest installed base of any immunoassay system worldwide. These systems offer multi-parameter instruments using ELFA (Enzyme Linked Fluorescent Assay) technology, based on a ready-to-use single-sample test concept. The analyses may be run in a series or individually. Launched in 1992, the VIDAS product range has earned a reputation for quality and reliability. Today the VIDAS menu includes 91 clinical parameters covering a wide range of human pathologies: identification and quantification of bacteria, viruses and parasites, antibodies measuring the immunological response to an infection such as AIDS and different proteins circulating in the blood, markers for selected cardio-vascular diseases and certain cancers, inflammatory response and hormonal dysfunction.

About bioMérieux

Advancing Diagnostics to Improve Public Health

A world leader in the field of in vitro diagnostics for 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2008, revenues reached €1.111 billion with 84% of sales outside of France.

bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMérieux is listed on the NYSE Euronext Paris market (Code: BIM – Code ISIN: FR0010096479). Other information can be found at www.biomerieux-usa.com.

bioMérieux Contacts

bioMérieux
Allan Mohess
Tel : + 1 919 620-2937
allan.mohess@na.biomerieux.com

Fleishman Hillard
Kimberly Mays
Tel : + 1 216 928 3459
kimberly.mays@fleishman.com