New Guidelines Include Molecular Testing of Biomarkers in Predicting Late Recurrence.

 

SAN DIEGO, Calif., March 15, 2017 – New guidelines recently published by the European Group on Tumor Markers (EGTM) recommend that the validated biomarker, Breast Cancer Index (BCI), may be used to predict outcome and aid in adjuvant therapy decision-making for ER+ positive early-stage breast cancer patients. In addition, the EGTM specifically highlighted the ability of BCI to detect risk of late recurrences (>5 years post-diagnosis) and cited research demonstrating that BCI showed improved performance versus several other biomarkers in predicting late recurrence. According to the guidelines, “BCI may thus be of value for the identification of ER-positive lymph node-negative patients that may not require extended endocrine therapy after 5 years of treatment.”

BCI is the only currently available validated biomarker that is both prognostic for late distant recurrence and predictive for likelihood of benefit from extended endocrine therapy (EET).

“The BCI biomarker has reached an important milestone with Clinical Guideline recognition in the extended endocrine setting, as the use of genomic tools has become increasingly important to potentially select appropriate patients ” said Catherine Schnabel, PhD, Chief Scientific Officer at Biotheranostics, Inc. “The European Group on Tumor Markers’ inclusion of BCI in the updated guidelines only serves to underscore BCI’s value in that decision-making process,” she continued.

About Breast Cancer IndexSM

BCI is a molecular, gene expression-based test uniquely positioned to help identify patients best suited for extended endocrine treatment. It is the only validated, commercially available test with data demonstrating prognostic risk of recurrence out to 15 years, as well as prediction of likelihood of benefit from extended endocrine therapy (treatment in years 5-10). The breakthrough test helps oncologists and patients navigate the difficult trade-off between wanting to take steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to extended endocrine therapy. For more information, visit breastcancerindex.com.

About Biotheranostics

Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary genomics-based molecular diagnostics that allow treatment to be tailored to individual patients. The company's Breast Cancer IndexSM and CancerTYPE ID® tests address a variety of unmet medical needs in the management of cancer patients, and extensive clinical studies have confirmed the accuracy, clinical validity, clinical utility, and cost-effectiveness of the tests. Biotheranostics operates a CLIA-certified, CAP-accredited diagnostic laboratory in San Diego. Learn more at biotheranostics.com.

 

Breast Cancer Index Intended Use and Limitations

BCI provides a quantitative assessment of the likelihood of distant recurrence in patients diagnosed with ER+ node-negative breast cancer, and prediction of likelihood of benefit from extended (>5 year) endocrine therapy in patients who are recurrence-free after an initial 5 years of adjuvant endocrine therapy. Treatment decisions require correlation with all other clinical findings. This test was developed and its performance characteristics determined by Biotheranostics, Inc. lt has not been cleared or approved by the U.S. Food and Drug Administration. This test is used for clinical purposes. lt should not be regarded as investigational or for research. How this information is used to guide patient care is the responsibility of the physician. Biotheranostics is certified under the Clinical Laboratory lmprovement Amendments of 1988 to perform high-complexity clinical laboratory testing.

Biotheranostics Page

Biotheranostics, Inc. | 9640 Towne Centre Drive | Suite 200 | San Diego, CA 92121 | Biotheranostics.com

US and International: +1 (858) 587-5870 | Fax: +1 (800) 266-9607 | Client Services: +1 (877) 886-6739 | Billing Information: +1 (888) 286-0755 | Patient Advocates Team: +1 (844) 319-8111

© 2018 Biotheranostics, Inc. Breast Cancer Index and BCI are service marks of Biotheranostics, Inc.