New Data From Biotheranostics, Inc. Further Demonstrate the Value of CancerTYPE ID to Help Identify Metastatic Cancers with an Unknown or Unclear Tumor Type Diagnosis

Jun 8, 2017 - (Newswire)

- Biotheranostics, Inc. announced two studies published as part of the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago this week. The studies support the clinical utility of CancerTYPE ID - the company's proprietary, validated 92-gene assay which provides a molecular-based diagnosis for metastatic cancers in which the tumor type is unknown or unclear following initial workup. Both studies utilized analyses of a large database (N= 24,484) of cases submitted for clinical testing with CancerTYPE ID. Results highlight CancerTYPE ID's ability to identify distinct subtypes of neuroendocrine tumors (NET), and to identify metastatic cancers with tumor types that may be eligible for checkpoint inhibitor immunotherapy treatment based on current FDA-approved indications.

In the first study, results showed that CancerTYPE ID rendered a molecular diagnosis of NET in 6.3% of cases submitted for CancerTYPE ID testing. Small/large cell lung carcinoma (50%) was the most common NET molecular diagnosis, followed by GI carcinoid (14%), islet cell (14%), Merkel cell (10%), and lung carcinoid (9%). As optimal surgical and pharmacologic treatment approaches differ across different NET types, these results demonstrate the clinical utility of CancerTYPE ID in patients with NETs that do not have a definitive subtype diagnosis.

In a second analysis, CancerTYPE ID rendered a molecular diagnosis for a tumor type with an approved checkpoint inhibitor in 27% (N = 6536) of cases examined. Of these cases, lung adenocarcinomas (31%) and urinary bladder cancers (20%) were the most common molecular diagnoses with approved checkpoint inhibitors. "The recent availability of checkpoint inhibitors in only specific metastatic cancer types further strengthens the value of CancerTYPE ID," said Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics . "If a definitive tumor type cannot be identified following standard workup, CancerTYPE ID can help identify a patient's tumor type, in which an approved immunotherapy may be an option."

CancerTYPE ID Indications for Use and Limitations
CancerTYPE ID is indicated for use in tumor specimens from patients diagnosed with malignant disease and is intended to aid in the classification of the tissue of origin and tumor subtype in conjunction with standard clinical and pathological assessment by a qualified physician. CancerTYPE ID is not intended to predict patient survival benefit, treatment efficacy or to distinguish between benign versus malignant lesions. Tumor types not included in the CancerTYPE ID reference database may exhibit RNA expression patterns that are similar to RNA expression patterns within the reference database. This test was developed and performance characteristics have been determined by Biotheranostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. This test is used for clinical purposes. It 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 Improvement Amendments of 1988 as qualified to perform high-complexity clinical laboratory testing.

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 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. Biotheranostics is based in San Diego. For more information, visit www.biotheranostics.com.

SOURCE Biotheranostics, Inc.

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