- Studies presented in collaboration with centers of excellence in cancer treatment and translational research

- CancerTYPE ID provided molecular resolution in the diagnosis of bone-predominant metastatic disease where traditional methods had been limited

- Breast Cancer Index identified more patients with minimal (1-2%) risk of breast cancer death than another test evaluated in the same randomized trial

 

SAN DIEGO, Calif., June 1, 2018 – Biotheranostics, Inc. announces new data from studies for both of its proprietary molecular diagnostic tests, CancerTYPE ID and Breast Cancer Index (BCI) to be presented on Saturday, June 2nd and Monday, June 4th at the annual meeting of the American Society of Clinical Oncology in Chicago.

In a longstanding diagnostic and treatment dilemma, 30% of patients with bone metastases do not receive a definitive diagnosis of tumor type because of poor tumor differentiation and degradation of tumor markers during specimen processing. In a study of over 1200 cases of patients with unknown or uncertain cancer, CancerTYPE ID demonstrated a solid analytical success rate in bone biopsies, with more than 40% of cases receiving a molecular tumor type diagnosis for which an FDA-approved indication for immune checkpoint inhibitors is available.

“The results of this analysis demonstrate that CancerTYPE ID provides a foundation for a very promising diagnostic workflow for patients presenting with bone-predominant metastatic disease,” said Kanwal P. S. Raghav, MBBS, MD, study author and Assistant Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. “Whereas in the past, a large proportion of these patients would not have received a definitive diagnosis, now, with integration of the tissue-sparing 92-gene assay, the molecular diagnosis of tumor type allows for more appropriate tumor-specific therapy planning, downstream biomarker testing as well as consideration of immunotherapy enriched clinical trials for select patients.”

Evaluation of long-term risk of breast cancer recurrence is another clinical situation requiring individualization of therapy. Breast Cancer Index (BCI) identified nearly 30% of estrogen receptor positive breast cancer patients with 98% long-term breast cancer–specific survival (BCSS) out to 20 years, indicating that these patients may be effectively treated with a five-year course of anti-estrogen therapy. For comparison, a recent analysis of a genomic biomarker in the same Stockholm randomized controlled trial examining indolent biology revealed that only 15% of patients were classified as ‘ultralow risk,’ with a corresponding 20-year BCSS of 97%.

In other studies, Breast Cancer Index significantly predicted pathological complete response to neoadjuvant chemotherapy (NACT) in estrogen receptor positive (ER+) breast cancer patients, beyond traditional clinicopathologic factors and was correlated with overall survival. The potential clinical utility of BCI for predicting which patients are likely to respond to, and which patients may be spared and might consider alternative treatment strategies, such as neoadjuvant endocrine therapy, has been met with enthusiasm and warrants additional study. Additionally, an analysis was completed to further characterize BCI and BCIN+, the algorithm optimized for lymph node positive disease (N1, 0-3 lymph nodes) with the addition of tumor size and tumor grade and available since June 2016, for the prediction of late distant recurrence in post-menopausal women with hormone receptor positive breast cancer treated with tamoxifen or anastrozole. Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics said, “We continue to be excited with the ability of Breast Cancer Index to stratify hormone receptor positive patients into clinically meaningful subsets for optimal treatment. Aside from validated data to aid in decision-making for addition of chemotherapy and/or extended endocrine therapy, the biomarker has emerging activity in the neoadjuvant setting.”

About CancerTYPE ID®

CancerTYPE ID is the market-leading molecular, gene expression-based test focused on the classification of metastatic cancer and is intended to aid in the diagnosis of the tumor type and subtype of cancers with diagnostic uncertainty, in conjunction with standard clinical and pathological assessment. Commercially launched in 2010, CancerTYPE ID is a standardized, objective molecular test based on the differential expression of 92 genes that classifies tumors by matching the gene expression pattern of a tumor specimen to a database of known tumor types and histological subtypes. CancerTYPE ID is able to classify 50 cancer types and subtypes, representing more than 95 percent of all solid tumors based on incidence. For more information, visit cancertypeid.com.

About Breast Cancer IndexTM

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 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

- Studies presented in collaboration with centers of excellence in cancer treatment and translational research

- CancerTYPE ID provided molecular resolution in the diagnosis of bone-predominant metastatic disease where traditional methods had been limited

- Breast Cancer Index identified more patients with minimal (1-2%) risk of breast cancer death than another test evaluated in the same randomized trial

 

SAN DIEGO, Calif., June 1, 2018 – Biotheranostics, Inc. announces new data from studies for both of its proprietary molecular diagnostic tests, CancerTYPE ID and Breast Cancer Index (BCI) to be presented on Saturday, June 2nd and Monday, June 4th at the annual meeting of the American Society of Clinical Oncology in Chicago.

In a longstanding diagnostic and treatment dilemma, 30% of patients with bone metastases do not receive a definitive diagnosis of tumor type because of poor tumor differentiation and degradation of tumor markers during specimen processing. In a study of over 1200 cases of patients with unknown or uncertain cancer, CancerTYPE ID demonstrated a solid analytical success rate in bone biopsies, with more than 40% of cases receiving a molecular tumor type diagnosis for which an FDA-approved indication for immune checkpoint inhibitors is available.

“The results of this analysis demonstrate that CancerTYPE ID provides a foundation for a very promising diagnostic workflow for patients presenting with bone-predominant metastatic disease,” said Kanwal P. S. Raghav, MBBS, MD, study author and Assistant Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. “Whereas in the past, a large proportion of these patients would not have received a definitive diagnosis, now, with integration of the tissue-sparing 92-gene assay, the molecular diagnosis of tumor type allows for more appropriate tumor-specific therapy planning, downstream biomarker testing as well as consideration of immunotherapy enriched clinical trials for select patients.”

Evaluation of long-term risk of breast cancer recurrence is another clinical situation requiring individualization of therapy. Breast Cancer Index (BCI) identified nearly 30% of estrogen receptor positive breast cancer patients with 98% long-term breast cancer–specific survival (BCSS) out to 20 years, indicating that these patients may be effectively treated with a five-year course of anti-estrogen therapy. For comparison, a recent analysis of a genomic biomarker in the same Stockholm randomized controlled trial examining indolent biology revealed that only 15% of patients were classified as ‘ultralow risk,’ with a corresponding 20-year BCSS of 97%.

In other studies, Breast Cancer Index significantly predicted pathological complete response to neoadjuvant chemotherapy (NACT) in estrogen receptor positive (ER+) breast cancer patients, beyond traditional clinicopathologic factors and was correlated with overall survival. The potential clinical utility of BCI for predicting which patients are likely to respond to, and which patients may be spared and might consider alternative treatment strategies, such as neoadjuvant endocrine therapy, has been met with enthusiasm and warrants additional study. Additionally, an analysis was completed to further characterize BCI and BCIN+, the algorithm optimized for lymph node positive disease (N1, 0-3 lymph nodes) with the addition of tumor size and tumor grade and available since June 2016, for the prediction of late distant recurrence in post-menopausal women with hormone receptor positive breast cancer treated with tamoxifen or anastrozole. Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics said, “We continue to be excited with the ability of Breast Cancer Index to stratify hormone receptor positive patients into clinically meaningful subsets for optimal treatment. Aside from validated data to aid in decision-making for addition of chemotherapy and/or extended endocrine therapy, the biomarker has emerging activity in the neoadjuvant setting.”

About CancerTYPE ID®

CancerTYPE ID is the market-leading molecular, gene expression-based test focused on the classification of metastatic cancer and is intended to aid in the diagnosis of the tumor type and subtype of cancers with diagnostic uncertainty, in conjunction with standard clinical and pathological assessment. Commercially launched in 2010, CancerTYPE ID is a standardized, objective molecular test based on the differential expression of 92 genes that classifies tumors by matching the gene expression pattern of a tumor specimen to a database of known tumor types and histological subtypes. CancerTYPE ID is able to classify 50 cancer types and subtypes, representing more than 95 percent of all solid tumors based on incidence. For more information, visit cancertypeid.com.

About Breast Cancer IndexTM

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 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.