SAN DIEGO, Oct. 6 /PRNewswire/ -- bioTheranostics, a bioMerieux company that discovers, develops and commercializes new molecular diagnostic tests in oncology, announced that the company has signed a two-year agreement with Lab21 to commercialize the bioTheranostics THEROS CancerTYPE ID molecular cancer classifier in the United Kingdom (UK), Ireland and Middle East countries. The agreement is effective immediately.
Under the terms of the agreement, UK-based Lab21 will market the THEROS CancerTYPE ID (CTID) molecular cancer classifier, while bioTheranostics will perform all sample testing in their CLIA-certified, CAP-accredited laboratory in San Diego, California.
The CTID assay is a 92-gene molecular cancer classifier that identifies 39 different types of tumors and 64 sub-types. It is particularly useful for oncologists and pathologists managing metastatic cancer patients whose primary tumor site (e.g., breast, lung, pancreas) is either "uncertain" or "unknown" following assessment with conventional diagnostics. The results of the CTID assay can guide physicians in selecting optimal therapies for these individuals and potentially improve treatment outcomes. Each year in the UK alone, more than 10,000 people are diagnosed with a cancer of unknown primary origin (aka CUP), and far more patients struggle with a differential diagnosis (i.e., two or more diagnostic options), each of which may lead to a different treatment path.
"We recognize a tremendous need globally for new technologies that will help physicians more quickly and accurately diagnose poorly differentiated and undifferentiated tumors, so that they can determine the optimal therapy for each patient," said Richard Ding, bioTheranostics chief executive officer. "Given Lab21's infrastructure and unique commercial expertise in personalized medicine, we know they are the right partner to deliver the THEROS CancerTYPE ID to doctors and patients in the specified countries."
"The partnership with Lab21 represents the successful transition to our second generation molecular cancer classification technology in Europe. This RT-PCR based test will replace our micro-array based assay, which was licensed to Agendia in Europe," said Ding. "Now through Lab 21, oncologists and pathologists in the specified countries can benefit from the new technology just as their American counterparts."
bioTheranostics discovers, develops and commercializes molecular diagnostic tests for cancer patients. Leveraging its unique expertise in genomic profiling and proprietary algorithms, bioTheranostics provides innovative tests to the oncology community that help drive personalized treatment. The company operates a CLIA-certified, CAP-accredited diagnostic service laboratory in San Diego, CA to perform its proprietary molecular diagnostic tests: THEROS CancerTYPE ID(®), a molecular cancer classifier particularly helpful for patients diagnosed with metastatic cancer with their tumor origin either as uncertain or unknown or patients with their cancer origin not confirmable through conventional diagnostics; and the THEROS Breast Cancer Index(®), which refines and improves risk stratification in patients with estrogen receptor (ER)-positive, lymph-node negative breast cancer. More information is available at www.bioTheranostics.com.
Advancing Diagnostics to Improve Public Health
A world leader in the field of in vitro diagnostics for over 45 years, bioMerieux is present in 150 countries through 39 subsidiaries and a large network of distributors. In 2008, revenues reached euro 1.111 billion with 84% of sales outside of France.
bioMerieux provides diagnostic solutions (reagents, instruments, software) that 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 agro-food, pharmaceutical and cosmetic products. bioMerieux is listed on the NYSE Euronext Paris market (Code: BIM - Code ISIN: FR0010096479). Other information can be found at www.biomerieux.com.
About Lab21 Limited
Lab21 is a global provider of state-of-the-art diagnostic products and services, supporting blood bank screening, medical diagnostics and drug discovery. Its customers include international healthcare providers, pharmaceutical and biotechnology companies. The service division has a growing test portfolio providing companion diagnostics and high technology molecular assays for the growing integration of personalized medicine into healthcare. These services are currently in infectious diseases, oncology and pharmacogenetics areas with emerging interests in cardiovascular and metabolic disease. The product division of the Company manufactures immunodiagnostic kits and reagents that are distributed into 110 international countries and is focused on infectious diseases for the blood-banking market. More information is available at www.lab21.com.
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