SAN DIEGO, Calif., February 26, 2018 – Biotheranostics, Inc. announces publication of comparative performance results of its Breast Cancer Index (BCI) with other commercially available genomic tests for women with early stage hormone receptor positive breast cancer. Notably, in patients for whom disease has not spread to the lymph-nodes, BCI was one of the strongest prognostic biomarkers for both predicting overall 10-year distant metastasis as well as late relapse, independent of clinical factors traditionally used for determining patient risk.

In the analysis published in JAMA Oncology, Sestak, et al. compared four commercially available tests: two built on genomic signatures alone, and two that also require integration of traditional clinical information in lymph node negative (N0) and lymph node positive (N1) patients across two-time frames relevant to key therapeutic decisions: 0-10 and 5-10 years. BCI was the strongest test based on gene expression alone for prediction of disease recurrence in lymph node negative patients being evaluated for chemotherapy (0-10 year assessment of overall recurrence); BCI was also the strongest performing gene expression only test to help inform the duration of endocrine therapy (late distant recurrence in years 5-10), identifying over 63% of patients as having less than a 3% risk of distant recurrence.

In women with node positive disease, all tests provided significant, albeit less prognostic information than in lymph node negative disease. The incorporation of clinical information with the multi-gene signatures improved prognostic value in node positive patients. Although not assessed in this analysis, an optimized BCI algorithm for node positive patients which includes both tumor size and grade was validated in a patient cohort with similar characteristics. In this cohort, BCI identified 22% of N1 patients as having a 2.1% risk of late distant recurrence of breast cancer from years 5-15. The development and clinical validation of the optimized BCI algorithm for node positive patients has been published in Clinical Cancer Research.

Additionally, the Sestak, et al study focused solely on the prognostic information provided by these four multi-gene tests, and did not evaluate the individual tests’ ability to predict the benefit from chemotherapy or extended endocrine. Catherine Schnabel, Chief Scientific Officer, Biotheranostics clarifies, “As BCI is the only test amongst those examined in the study that provides validated information on the likelihood of benefit from extended endocrine therapy in addition to prognostic information on late recurrence, it is uniquely suited and has broad adoption to inform the decision around extension of endocrine therapy beyond 5 years.”

Those that treat breast cancer patients traditionally make use all of the available tools to help best inform decision making. Clinical factors like tumor size, grade and nodal status routinely figure into a clinician’s approach to treating patients. The genomic revolution now permits evaluation of tumor biology alone very successfully in N0 patients, and in combination with clinical and pathologic factors to better assess risk of recurrence in N1 patients. The complete publication and the supplements can be viewed here: https://doi.org/10.1001/jamaoncol.2017.5524.

About Breast Cancer IndexSM

BCI is a molecular, gene expression-based test uniquely positioned to help identify patients with early-stage, ER+ breast cancer who may be suitable candidates for extended endocrine treatment. It is the only validated, commercially available test that predicts risk of late distant recurrence, as well as the likelihood of benefit from extended endocrine therapy. This breakthrough test helps oncologists and patients navigate the difficult trade-off between taking 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. operates a CLIA-certified and CAP-accredited diagnostic laboratory in San Diego, California. Biotheranostics, Inc., is a leading healthcare provider in the oncology field assisting physicians in the treatment of cancer patients. Its suite of proprietary molecular diagnostic tests provides important information to physicians to tailor treatment 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. 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.

News and Press | Breast Cancer Index

 

 

SAN DIEGO, Calif., February 26, 2018 – Biotheranostics, Inc. announces publication of comparative performance results of its Breast Cancer Index (BCI) with other commercially available genomic tests for women with early stage hormone receptor positive breast cancer. Notably, in patients for whom disease has not spread to the lymph-nodes, BCI was one of the strongest prognostic biomarkers for both predicting overall 10-year distant metastasis as well as late relapse, independent of clinical factors traditionally used for determining patient risk.

In the analysis published in JAMA Oncology, Sestak, et al. compared four commercially available tests: two built on genomic signatures alone, and two that also require integration of traditional clinical information in lymph node negative (N0) and lymph node positive (N1) patients across two-time frames relevant to key therapeutic decisions: 0-10 and 5-10 years. BCI was the strongest test based on gene expression alone for prediction of disease recurrence in lymph node negative patients being evaluated for chemotherapy (0-10 year assessment of overall recurrence); BCI was also the strongest performing gene expression only test to help inform the duration of endocrine therapy (late distant recurrence in years 5-10), identifying over 63% of patients as having less than a 3% risk of distant recurrence.

In women with node positive disease, all tests provided significant, albeit less prognostic information than in lymph node negative disease. The incorporation of clinical information with the multi-gene signatures improved prognostic value in node positive patients. Although not assessed in this analysis, an optimized BCI algorithm for node positive patients which includes both tumor size and grade was validated in a patient cohort with similar characteristics. In this cohort, BCI identified 22% of N1 patients as having a 2.1% risk of late distant recurrence of breast cancer from years 5-15. The development and clinical validation of the optimized BCI algorithm for node positive patients has been published in Clinical Cancer Research.

Additionally, the Sestak, et al study focused solely on the prognostic information provided by these four multi-gene tests, and did not evaluate the individual tests’ ability to predict the benefit from chemotherapy or extended endocrine. Catherine Schnabel, Chief Scientific Officer, Biotheranostics clarifies, “As BCI is the only test amongst those examined in the study that provides validated information on the likelihood of benefit from extended endocrine therapy in addition to prognostic information on late recurrence, it is uniquely suited and has broad adoption to inform the decision around extension of endocrine therapy beyond 5 years.”

Those that treat breast cancer patients traditionally make use all of the available tools to help best inform decision making. Clinical factors like tumor size, grade and nodal status routinely figure into a clinician’s approach to treating patients. The genomic revolution now permits evaluation of tumor biology alone very successfully in N0 patients, and in combination with clinical and pathologic factors to better assess risk of recurrence in N1 patients. The complete publication and the supplements can be viewed here: https://doi.org/10.1001/jamaoncol.2017.5524.

About Breast Cancer IndexSM

BCI is a molecular, gene expression-based test uniquely positioned to help identify patients with early-stage, ER+ breast cancer who may be suitable candidates for extended endocrine treatment. It is the only validated, commercially available test that predicts risk of late distant recurrence, as well as the likelihood of benefit from extended endocrine therapy. This breakthrough test helps oncologists and patients navigate the difficult trade-off between taking 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. operates a CLIA-certified and CAP-accredited diagnostic laboratory in San Diego, California. Biotheranostics, Inc., is a leading healthcare provider in the oncology field assisting physicians in the treatment of cancer patients. Its suite of proprietary molecular diagnostic tests provides important information to physicians to tailor treatment 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. 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.