- Broadened coverage for post-menopausal women receiving Breast Cancer Index genomic testing to aid in extended endocrine therapy decision-making.

 

SAN DIEGO, Calif., March 5, 2019 – Biotheranostics, Inc., announces its Breast Cancer Index (BCI) test has been issued a new Medicare Local Coverage Determination [(LCD) L37822] by Noridian, effective April 16, 2019. Based on additional studies and inclusion of BCI in clinical practice guidelines, the new LCD provides significantly broader coverage for patients with hormone receptor positive (HR+), early stage breast cancer than previously issued for the test in 2014.

Under the new criteria, BCI will be covered for post-menopausal women diagnosed with early-stage, node negative, non-relapsed, ER and/or PR positive, HER2 negative breast cancer to help physicians determine treatment management of the patient for chemotherapy and/or extended endocrine therapy.

For patients diagnosed with HR+, early-stage breast cancer, results across multiple clinical trials investigating the optimal duration of extended endocrine therapy remain inconclusive, and support the increasing role of genomic tests, including BCI, to help individualize patient selection. Most recently, the American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Focused Update on Adjuvant Endocrine Therapy for Women with Hormone Receptor Positive Breast Cancer reinforces this solution, endorsing genomic tests such as BCI, to aid in decisions regarding extended adjuvant endocrine therapy with aromatase inhibition for post-menopausal patients with early-stage, HR+ breast cancer.

Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics, said, “We are pleased that Medicare and Palmetto MolDx have continued to recognize the clinical utility of BCI and the strength of its clinical validation, thus increasing patient and physician access to this important technology. By providing both prognostic and predictive results, BCI serves as an integral molecular correlate of risk and endocrine benefit to better individualize extension of endocrine treatment.”

Don Hardison, Biotheranostics’ President and CEO, added, “We are thrilled that Medicare has awarded expanded coverage for HR+ early stage, post-menopausal patients. Physicians and patients may now obtain predictive information for shared decision-making about an individual’s benefit of extended endocrine therapy. 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 BCI—the individualized treatment benefit of prediction needed to personalize anti-estrogen therapy beyond 5 years for each patient.”

BCI is the only test validated to predict the likelihood of benefit of extended endocrine therapy to help physicians with recommendations related to treatment of their patients beyond 5 years. No other genomic tests or clinicopathologic factors have demonstrated the ability to predict extended endocrine therapy response.

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 provides risk of overall and late distant recurrence and predicts 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 Index® 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

- Broadened coverage for post-menopausal women receiving Breast Cancer Index genomic testing to aid in extended endocrine therapy decision-making.

 

SAN DIEGO, Calif., March 5, 2019 – Biotheranostics, Inc., announces its Breast Cancer Index (BCI) test has been issued a new Medicare Local Coverage Determination [(LCD) L37822] by Noridian, effective April 16, 2019. Based on additional studies and inclusion of BCI in clinical practice guidelines, the new LCD provides significantly broader coverage for patients with hormone receptor positive (HR+), early stage breast cancer than previously issued for the test in 2014.

Under the new criteria, BCI will be covered for post-menopausal women diagnosed with early-stage, node negative, non-relapsed, ER and/or PR positive, HER2 negative breast cancer to help physicians determine treatment management of the patient for chemotherapy and/or extended endocrine therapy.

For patients diagnosed with HR+, early-stage breast cancer, results across multiple clinical trials investigating the optimal duration of extended endocrine therapy remain inconclusive, and support the increasing role of genomic tests, including BCI, to help individualize patient selection. Most recently, the American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Focused Update on Adjuvant Endocrine Therapy for Women with Hormone Receptor Positive Breast Cancer reinforces this solution, endorsing genomic tests such as BCI, to aid in decisions regarding extended adjuvant endocrine therapy with aromatase inhibition for post-menopausal patients with early-stage, HR+ breast cancer.

Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics, said, “We are pleased that Medicare and Palmetto MolDx have continued to recognize the clinical utility of BCI and the strength of its clinical validation, thus increasing patient and physician access to this important technology. By providing both prognostic and predictive results, BCI serves as an integral molecular correlate of risk and endocrine benefit to better individualize extension of endocrine treatment.”

Don Hardison, Biotheranostics’ President and CEO, added, “We are thrilled that Medicare has awarded expanded coverage for HR+ early stage, post-menopausal patients. Physicians and patients may now obtain predictive information for shared decision-making about an individual’s benefit of extended endocrine therapy. 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 BCI—the individualized treatment benefit of prediction needed to personalize anti-estrogen therapy beyond 5 years for each patient.”

BCI is the only test validated to predict the likelihood of benefit of extended endocrine therapy to help physicians with recommendations related to treatment of their patients beyond 5 years. No other genomic tests or clinicopathologic factors have demonstrated the ability to predict extended endocrine therapy response.

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 provides risk of overall and late distant recurrence and predicts 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 Index® 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.