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Three Clinical Studies of bioTheranostics Molecular Breast Cancer Diagnostics Presented at San Antonio Breast Cancer Symposium

Sunday, December 14, 2008 General News J E 4
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SAN DIEGO, Dec. 14 bioTheranostics, a bioMerieux companythat discovers, develops and commercializes new molecular diagnostic tests inoncology, reported today findings from three studies using the company'smolecular breast cancer assay to predict risk of disease recurrence inindividual patients. Data from the studies were presented this week at the SanAntonio Breast Cancer Symposium (SABCS).

The Theros Breast Cancer Index(SM) (BCI) is a combination of TherosH/I(SM) (HOXB13:IL17BR) and Theros MGI(SM) (Molecular Grade Index), twomolecular biomarkers that refine and improve risk stratification in patientswith estrogen receptor (ER)-positive, lymph node-negative breast cancer.

Data presented at the San Antonio meeting this week provide furtherevidence that the Theros BCI is a valuable tool for helping oncology medicalprofessionals and patients make information-based decisions regarding breastcancer therapy.

On Thursday, Dennis Sgroi, MD, presented results from a study comparingbreast cancer risk recurrence stratification by Oncotype DX versus TherosBreast Cancer Index. Dr. Sgroi and colleagues at Massachusetts GeneralHospital (MGH) Cancer Center and the Brigham and Womens Hospital, along withcolleagues at Indiana University and University of Alabama at Birmingham,looked at tumor samples from 166 estrogen-receptor positive patients for whichan Oncotype DX Recurrence Score (RS) of high, intermediate or low waspreviously reported. The study found that using the combined H/I-MGIbiomarkers (Theros BCI) to assess risk recurrence resulted in a smallerintermediate risk group than OncoType Dx (18 percent versus 47 percent,respectively) by re-stratifying a large number of patients with anintermediate Oncotype DX recurrence score into low and high risk groups.

"We know the best way to treat early stage breast cancer patients whoserisk recurrence is 'low' or 'high'," said Dr. Sgroi. "The ability to reducethe number of patients in the 'intermediate' group by reclassifying them aseither 'high' or 'low' risk, making risk prediction more specific, should go along way in helping medical professionals select the most appropriate therapyfor each of their patients."

On Saturday, Matthew Goetz, M.D., from Mayo Clinic and colleagues fromAustria presented data examining the predictive utility of CYP2D6 and theprognostic utility of the Theros Breast Cancer Index in women with breastcancer randomized to receive five years of treatment with tamoxifen or twoyears of tamoxifen followed by three years anastrozole treatment. Theresearchers found that the Theros Breast Cancer Index will identify, amongpatients with early stage breast cancer, those with a higher risk of treatmentfailure when treated only with hormonal therapy. They concluded that theTheros Breast Cancer Index identified approximately 25 percent of grade 1 andgrade 2 breast cancers that had a nearly three-fold higher risk for asubsequent recurrence in distant organs.

Finally, data from a study presented on Sunday by Olle Stal, PhD, andcolleagues from Linkoping University in Sweden explored the value of theHOXB13 gene in predicting benefit of tamoxifen therapy. Researchers reviewedHOXB13 protein expression in tumor samples from 866 patients with estrogen-receptor positive tumors. Patients whose tumors expressed no or low levels ofHOXB13 had a clear benefit from tamoxifen in terms of longer distantrecurrence-free survival. Patients with a high or intermediate HOXB13expression did not experience a distant recurrence-free survival benefit fromtamoxifen as compared to untreated patients.

"Data from these studies reinforce clinical and research experience todate which has shown that the Theros Breast Cancer Index is an excellent testfor assessing breast cancer risk prognosis and provides valuable informationto physicians treating patients, particularly the most common group of ER-positive, node-negative patients," said Richard Ding, chief executive officerof bioTheranostics. "As suggested by one of the studies presented this week,our test offers additional risk assessment over the leading competitor byproviding a more informative picture of the intermediate risk group. We lookforward to further expanding and validating this test with both additionalresearch and real-world clinical experience."

About bioTheranostics

Advancing Molecular Diagnostics in Oncology

bioTheranostics discovers, develops and commercializes moleculardiagnostic tests for cancer patients. Leveraging its unique expertise incancer molecular profiling and proprietary algorithms, bioTheranosticsprovides innovative tests to the oncology community that drive personalizedtreatment. The company operates a CLIA-certified, CAP-accredited diagnosticservice laboratory in San Diego, CA to perform its proprietary moleculardiagnostic tests: the Theros Breast Cancer Index(SM), a combination ofTheros H/I(SM) (HOXB13:IL17BR) and Theros MGI(SM) (Molecular Grade Index) thatrefines and improves risk stratification in patients with estrogen receptor(ER)-positive, lymph-node negative breast cancer; and the Theros CancerTYPEID(R) cancer classification assay, which provides improved cancerclassification, particularly for patients diagnosed with metastatic cancerwhere the origin is uncertain or unknown. For more information call1-858-587-5870 or visit http://www.bioTheranostics.com.

A world leader in the field of in vitro diagnostics for 45 years,bioMerieux is present in more than 150 countries through 39 subsidiaries and alarge network of distributors. In 2007, revenues reached Euro 1.063 billionwith 84% of sales outside of France.

bioMerieux provides diagnostic solutions (reagents, instruments, software)which determine the source of disease and contamination to improve patienthealth and ensure consumer safety. Its products are used for diagnosinginfectious diseases and providing high medical value results forcardiovascular emergencies and cancer screening and monitoring. They are alsoused for detecting microorganisms in agri-food, pharmaceutical and cosmeticproducts. bioMerieux is listed on the NYSE Euronext Paris market(Code: BIM - Code ISIN: FR0010096479). Other information can be found athttp://www.biomerieux.com.bioTheranostics Contacts David Dai Tel: 1 858 587 5894 david.dai@biotheranostics.com Michele Parisi Tel: 1 925 864 5028 mparisi@biocommnetwork.com About bioMerieux Advancing Diagnostics to Improve Public Health

SOURCE bioTheranostics
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