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Press Room

June 3, 2016

Study Presented at ASCO 2016 Shows Clinical Utility of Biotheranostics’ CancerTYPE® ID in Predicting Tumor Type & Aiding in Treatment Optimization for Metastatic Cancer Patients

Results Highlight Differences in Tumor Diagnosis by Age Group & Potential to Improve Therapy Selection, Particularly Among Younger Patients

FOR IMMEDIATE RELEASE…June 3, 2016…SAN DIEGO…A study demonstrating the clinical utility of Biotheranostics' CancerTYPE® ID molecular cancer classifier to provide a wide variety of molecular diagnoses in both young and older patients with metastatic cancer with unknown or uncertain primary site, and highlighting the potential to optimize treatment, will be presented at the 2016 American Society of Clinical Oncology conference. The meeting takes place June 3–7 at McCormick Place in Chicago.

In this large clinical case series done in collaboration with Sarah Cannon Research Institute and Tennessee Oncology in Nashville, Tenn., more than 22,000 cases with unknown or uncertain cancer diagnosis submitted for clinical testing with the CancerTYPE ID test were analyzed to assess differences in molecular diagnoses in young patients (under the age of 40) and older patients (age 40 or older), and to evaluate potential impact based on expected treatment response to first-line therapies in specific tumor types.

Consecutive cases submitted for testing between 2010 and 2015 were investigated, and patient age, gender, and distribution of molecular diagnoses provided by the assay were analyzed. To assess potential impact of CancerTYPE ID on treatment recommendations, molecular diagnoses were categorized as either responsive or less-responsive tumors based on median overall survival of ≥12 months and <12 months with standard first-line therapy, respectively; and tumors with available site-specific targeted therapy (including immunotherapy) were identified.

CancerTYPE ID provided a single molecular diagnosis in 95.3 percent of cases, with the most common predicted tumor types being pancreaticobiliary, squamous cell carcinoma, lung adenocarcinoma, intestine, and urinary bladder cancer. There were significant differences in the distribution of molecular diagnoses based on age. Predicted tumor types with significantly higher prevalence in young patients included intestine, sarcoma, germ cell, melanoma, thyroid, adrenal, sex cord stromal tumor, and meningioma. In addition, 54 percent of patients under age 40 had molecular diagnoses more likely to respond to standard site-directed therapies, and 58 percent had molecular diagnoses with available targeted therapy. In patients 40 or older, these proportions were 55 percent and 60 percent, respectively.

“This is one of the largest studies assessing the clinical utility of CancerTYPE ID, with more than half of the patients predicted to have more responsive tumor types or one with approved targeted therapy or immunotherapy—reinforcing the importance of obtaining an accurate diagnosis,” said Nicolas Barthelemy, President and CEO of Biotheranostics. “Identifying differences in tumor type by patient age group also may aid in improving outcomes, particularly in younger patients, where specialized treatment opportunities can arise. Clinicians are increasingly relying on CancerTYPE ID as a routine part of clinical practice when faced with difficult-to-diagnose metastatic cancers, and these results provide additional evidence of its clinical utility and important role in cancer care.”

The study, titled Molecular Diagnosis of Difficult to Diagnose Metastatic Cancers and Characterization of Young Patients: Clinical Experience with the 92-Gene Assay in >22,000 Cases, Abstract #11544, will be presented as a poster (Poster Board #251) on Monday, June 6, 2016, from 1:00 to 4:30 p.m. in Hall A. To access the abstract, click here.

Nicolas Barthelemy, president and CEO of Biotheranostics, said the data further demonstrate BCI's potential to improve the personalization of breast cancer treatment. "We are thrilled to see the evolution of BCI to now include a prognostic model for breast cancer patients with 1‑3 positive lymph nodes," Barthelemy said. "The results allow these patients to have a more substantial discussion with their doctors about their risk of recurrence and recommended treatment after five years of endocrine therapy."

About CancerTYPE® ID

CancerTYPE® ID is the market-leading 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.

About Biotheranostics

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. Its Breast Cancer IndexSM helps oncologists make difficult decisions about extended endocrine therapy for ER+ breast cancer patients based on its unique ability to predict risk of late disease recurrence and identify which patients are likely to benefit from continuing therapy beyond five years. For more information, visit