Test Predicts Risk of Recurrence & Drug Therapy Benefit in Breast Cancer Patients

FOR IMMEDIATE RELEASE…Oct. 15, 2014…SAN DIEGO…Biotheranostics, Inc., a leader in molecular diagnostics for cancer, today announced that its Breast Cancer IndexSM test has been awarded Medicare coverage. The Centers for Medicare and Medicaid Services posted a positive coverage and reimbursement policy after evaluation by Palmetto GBA, the Medicare administrator responsible for the MolDx molecular diagnostic technology assessment program.

The Breast Cancer Index is a molecular genomic test that quantifies risk of breast cancer recurrence and predicts which patients have a high likelihood of benefitting from extended endocrine therapy. The Medicare policy covers use of the test to predict risk of late (5-10 years) distant recurrence in women with early stage, estrogen receptor-positive breast cancer who are considering extended therapy but are concerned about continuing anti-hormonal therapy because of documented toxicity or possible significant patient-specific side effects. In addition to new claims, Medicare coverage and payment for the Breast Cancer Index will be made retrospectively for previously submitted claims.

Nicolas Barthelemy, President and CEO of Biotheranostics, said that securing Medicare coverage is a significant achievement and will help ensure broader patient access to an important breakthrough in breast cancer management. “We are pleased that we have attained such a significant milestone within the first eight months of full commercialization of the Breast Cancer Index—the only molecular test covered by Medicare that accurately assesses a patient’s individualized risk of breast cancer recurrence after five years and is validated to identify which patients will benefit from extended hormone therapy,” Barthelemy said. “This critical information will allow many women to avoid unnecessary treatment and potential side effects that can adversely affect their health and quality of life. We appreciate Palmetto GBA’s consideration and diligence in reaching this coverage decision.

"Women with breast cancer face difficult tradeoffs between wanting to take steps to help prevent the recurrence of their disease and facing significant side effects and costs related to extended endocrine treatments," said Ruth O’Regan, MD, MRCPI, Director of Translational Breast Cancer Research at the Winship Cancer Institute of Emory University. "The Breast Cancer Index provides important, patient-specific genomic information that helps clinicians identify patients who may not benefit from extended endocrine treatments, allowing them the choice of discontinuing therapy. For patients identified as at higher risk, clinicians now have information that they can use to emphasize the importance of compliance with treatment and establish appropriate follow-up. In light of recently updated ASCO guidelines encouraging consideration of extended endocrine treatment in some breast cancer patients beyond five years, the coverage of this test is particularly timely."

The Medicare coverage decision was based on a review of the scientific evidence supporting the analytical validity, clinical validity, and clinical utility of the Breast Cancer Index. It is one of the first coverage determinations for a molecular cancer diagnostic technology handed down by the rigorous evaluative process implemented by Palmetto GBA since the inception of MolDx in 2011.

About Breast Cancer Index

The Breast Cancer Index is a biomarker test that assesses distinct biological pathways for breast cancer. It addresses unmet clinical needs by accurately predicting late (5-10 years) distant recurrence, as well as benefit from extended endocrine therapy. About two-thirds of breast cancer patients are estrogen receptor-positive, and the risk of late distant recurrence is a substantial concern, with more than 50 percent of recurrences occurring after five years. Clinical research data on the Breast Cancer Index have been published in numerous peer-reviewed publications such as Lancet Oncology, Journal of the National Cancer Institute, and Clinical Cancer Research, and include more than 2,200 patients.

About Biotheranostics

Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary molecular diagnostic tests that allow treatment to be tailored to individual patients. The company’s Breast Cancer IndexSM helps oncologists make difficult decisions about extended endocrine therapy for ER+ breast cancer patients. Its CancerTYPE ID® is the most rigorously validated gene expression test for metastatic patients with diagnostic ambiguity, helping physicians determine optimal site-directed treatment regimens with the goal of improving patient outcomes. Biotheranostics, a bioMérieux company, is based in San Diego. For more information, visit www.biotheranostics.com or www.AnswersBeyond5.com. Follow BCI on Twitter at @AnswersByond5.

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.