- Clinical Practice Guidelines Recognize Breast Cancer Index Clinical Utility Spans the Treatment Continuum for Patients with Early-Stage Estrogen Receptor Positive (ER+) Disease

- Breast Cancer Index Endorsed in National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer and American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Focused Update

 

SAN DIEGO, Calif., November 28, 2018 – Biotheranostics, Inc. announces recommendations for Breast Cancer Index in both the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer and the American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Focused Update: Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer. Breast Cancer Index was endorsed as a multi-gene assay to aid in decisions regarding both the addition of chemotherapy and extended adjuvant endocrine therapy for patients with early-stage breast cancer.

Two key treatment decisions are priorities in the management of estrogen receptor positive (ER+) early-stage breast cancer: the first, whether the patient is of sufficient risk of recurrence to recommend systemic chemotherapy in addition to adjuvant endocrine therapy, and the second, whether to recommend extended endocrine therapy beyond the initial primary 5 years of adjuvant endocrine therapy. For each treatment decision, physicians and patients must determine whether the potential benefit from the additional therapy is likely to outweigh the potential risks of serious toxicities and side effects of treatment.

In support of the first treatment decision point, Breast Cancer Index was added to the NCCN Guidelines Breast Cancer Version 2.2018 “Multigene Assays for Consideration of Adjuvant Systemic Chemotherapy.” This recommendation is consistent with a 2016 ASCO Clinical Practice Guideline outlined in “Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women with Early-Stage Invasive Breast Cancer.”

In support of the second treatment decision point, the ASCO Guidelines Expert Panel stated that findings of established prognostic factors, including stage, grade, and genomic signatures, such as Breast Cancer Index, for both early and late recurrence have become sufficiently robust that a clinical risk stratification that reflects these prognostic factors could reasonably be used to inform the clinical decision about extended endocrine therapy.

Guidelines inclusion demonstrates that Breast Cancer Index has achieved an evidentiary threshold through its prognostic ability for assessing cumulative overall (0-10 year) risk and risk of late (post-5 year) distant recurrence, which has been consistently demonstrated in five blinded clinical studies, including two prospective-retrospective validation studies within randomized controlled trial cohorts.

“The recommendations by NCCN and ASCO reinforce and recognize the importance of genomic information to individualizing treatment for breast cancer,” said Catherine Schnabel, PhD, Chief Scientific Officer of Biotheranostics. “Breast Cancer Index is clinically validated to stratify patients across the continuum of breast cancer care based on cumulative overall risk of distant recurrence, risk of late distant recurrence, and likelihood of benefit from extended endocrine therapy. Breast Cancer Index is available to help physicians decide who should be treated with adjuvant chemotherapy and who should be treated with longer durations of endocrine therapy to help prevent disease recurrence versus those who might be spared the side effects and toxicities from these therapy regimens.”

Don Hardison, Biotheranostics’ President and CEO, said: “We are thrilled that in this recent update ASCO has recognized an equally important opportunity for shared decision making between physician and patient by recommending individualization of endocrine therapy for women with early-stage ER+ breast cancer based on risk of disease recurrence. For the past several years, Biotheranostics has stressed the importance of bringing a precision oncology approach to this decision by providing the recurrence risk and—unique to Breast Cancer Index—the individualized treatment benefit prediction needed to personalize anti-estrogen therapy beyond 5 years for each patient. Over 30,000 women have benefitted from the information Breast Cancer Index provides for decision making, and we are confident that with this endorsement many tens of thousands more women will benefit.”

For specific information about the guidelines, please visit https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf and https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9326.

About Breast Cancer Index®

Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, ER+ breast cancer. 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 unnecessary treatment. Breast Cancer Index holds guidelines designation from the American Joint Committee on Cancer for cancer staging based on molecular profile; ASCO, NCCN, European Group on Tumor Markers (EGTM) and St. Gallen to inform the chemotherapy decision; and ASCO and EGTM to inform the extended endocrine treatment dilemma. It is the only validated, commercially available test that predicts risk of overall and late distant recurrence, as well as the likelihood of benefit from 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 IndexTM 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

- Clinical Practice Guidelines Recognize Breast Cancer Index Clinical Utility Spans the Treatment Continuum for Patients with Early-Stage Estrogen Receptor Positive (ER+) Disease

- Breast Cancer Index Endorsed in National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer and American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Focused Update

 

SAN DIEGO, Calif., November 28, 2018 – Biotheranostics, Inc. announces recommendations for Breast Cancer Index in both the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer and the American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Focused Update: Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer. Breast Cancer Index was endorsed as a multi-gene assay to aid in decisions regarding both the addition of chemotherapy and extended adjuvant endocrine therapy for patients with early-stage breast cancer.

Two key treatment decisions are priorities in the management of estrogen receptor positive (ER+) early-stage breast cancer: the first, whether the patient is of sufficient risk of recurrence to recommend systemic chemotherapy in addition to adjuvant endocrine therapy, and the second, whether to recommend extended endocrine therapy beyond the initial primary 5 years of adjuvant endocrine therapy. For each treatment decision, physicians and patients must determine whether the potential benefit from the additional therapy is likely to outweigh the potential risks of serious toxicities and side effects of treatment.

In support of the first treatment decision point, Breast Cancer Index was added to the NCCN Guidelines Breast Cancer Version 2.2018 “Multigene Assays for Consideration of Adjuvant Systemic Chemotherapy.” This recommendation is consistent with a 2016 ASCO Clinical Practice Guideline outlined in “Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women with Early-Stage Invasive Breast Cancer.”

In support of the second treatment decision point, the ASCO Guidelines Expert Panel stated that findings of established prognostic factors, including stage, grade, and genomic signatures, such as Breast Cancer Index, for both early and late recurrence have become sufficiently robust that a clinical risk stratification that reflects these prognostic factors could reasonably be used to inform the clinical decision about extended endocrine therapy.

Guidelines inclusion demonstrates that Breast Cancer Index has achieved an evidentiary threshold through its prognostic ability for assessing cumulative overall (0-10 year) risk and risk of late (post-5 year) distant recurrence, which has been consistently demonstrated in five blinded clinical studies, including two prospective-retrospective validation studies within randomized controlled trial cohorts.

“The recommendations by NCCN and ASCO reinforce and recognize the importance of genomic information to individualizing treatment for breast cancer,” said Catherine Schnabel, PhD, Chief Scientific Officer of Biotheranostics. “Breast Cancer Index is clinically validated to stratify patients across the continuum of breast cancer care based on cumulative overall risk of distant recurrence, risk of late distant recurrence, and likelihood of benefit from extended endocrine therapy. Breast Cancer Index is available to help physicians decide who should be treated with adjuvant chemotherapy and who should be treated with longer durations of endocrine therapy to help prevent disease recurrence versus those who might be spared the side effects and toxicities from these therapy regimens.”

Don Hardison, Biotheranostics’ President and CEO, said: “We are thrilled that in this recent update ASCO has recognized an equally important opportunity for shared decision making between physician and patient by recommending individualization of endocrine therapy for women with early-stage ER+ breast cancer based on risk of disease recurrence. For the past several years, Biotheranostics has stressed the importance of bringing a precision oncology approach to this decision by providing the recurrence risk and—unique to Breast Cancer Index—the individualized treatment benefit prediction needed to personalize anti-estrogen therapy beyond 5 years for each patient. Over 30,000 women have benefitted from the information Breast Cancer Index provides for decision making, and we are confident that with this endorsement many tens of thousands more women will benefit.”

For specific information about the guidelines, please visit https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf and https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9326.

About Breast Cancer Index®

Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, ER+ breast cancer. 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 unnecessary treatment. Breast Cancer Index holds guidelines designation from the American Joint Committee on Cancer for cancer staging based on molecular profile; ASCO, NCCN, European Group on Tumor Markers (EGTM) and St. Gallen to inform the chemotherapy decision; and ASCO and EGTM to inform the extended endocrine treatment dilemma. It is the only validated, commercially available test that predicts risk of overall and late distant recurrence, as well as the likelihood of benefit from 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 IndexTM 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.