DEC 9th presentation... OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive tests for the early detection of cancer, provided a summary of the data from its breast cancer diagnostic test that will be presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) in December. The data will be presented by Karen B. Chapman, Ph.D., OncoCyte's Vice President of Research, at 5:00pm CT on Friday, December 9.
The poster titled Development of a panel of serum-based protein biomarkers for the non-invasive detection of breast cancer in BI-RADS category 4 patients discusses details of OncoCyte's study, which collected serum samples from 100 women with suspicious diagnostic mammogram findings (primarily BI-RADS category 4) undergoing biopsy.
The study evaluated the samples on the SOMAscan Assay 1.3k, which measures 1,310 different proteins. Statistical screening methods were used to identify markers distinguishing benign from malignant samples and combine them into a multi-biomarker algorithm.
This study revealed a novel panel of serum protein biomarkers that may allow for the non-invasive and sensitive detection of breast cancer in BI-RADS category 4 patients. A 15-marker model resulted in an AUC of 0.92 with a sensitivity of 90% and specificity of 76%.
The Company is conducting a follow on multicenter study to further develop and verify these results in a larger set of prospectively collected patient samples.
BI-RADS (Breast Imaging and Reporting Data System) is a scoring system developed by the American College of Radiologists to help clinicians assess the risk of cancer in women with a lump or mass. BI-RADS 4 is the score given to a woman with a suspicious lump or mass.
Each year approximately 38 million women in the U.S. undergo mammogram screenings. Mammograms detect suspicious lumps or masses in about 1.5 to 2 million of these women, who then require an invasive follow-on breast tissue biopsy to determine if the mass is malignant or benign. However, only about 20% of these biopsies result in a cancer diagnosis. Consequently, the majority of biopsies are not needed, and result in unnecessary pain, discomfort and anxiety to women as well as an estimated $2.8 billion annual cost to the healthcare system.
OncoCyte is focused on developing a confirmatory diagnostic blood test that can be used as an adjunct to suspicious mammography results.
"Our goal is to reduce the number of unnecessary breast biopsies that women have to undergo," commented William Annett, President and Chief Executive Officer. "The data from this initial study is encouraging, and our diagnostic test was able to distinguish between benign and cancerous masses. To validate these findings we are now in the process of conducting a larger study. If successful, our test will address a patient population of approximately two million American women who have to have breast biopsies each year."
About Breast Cancer
Breast cancer is the second most common cancer among US women. Current screening guidelines set forth by the American Cancer Society recommend screening mammography for the early detection of breast cancer in women at average risk. Specifically, guidelines call for annual mammography for asymptomatic women age 45 to 54 and once every two years for women age 55 and older. Suspicious screening mammograms are generally followed up with a diagnostic mammogram and sometimes by an MRI (Magnetic Resonance Image) or an ultrasound. Ultimately, suspicious findings unresolved by imaging typically result in the recommendation of a breast biopsy.
About OncoCyte Corporation
OncoCyte is primarily focused on the development and commercialization of novel, non-invasive blood and urine ("liquid biopsy") diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients.
While current biopsy tests use invasive surgical procedures to provide tissue samples in order to determine if a tumor is benign or malignant, OncoCyte is developing a next generation of diagnostic tests that will be based on liquid biopsies using blood or urine samples. OncoCyte's pipeline products are intended to be confirmatory diagnostics for lung, bladder and breast cancer. OncoCyte's diagnostic tests are being developed using proprietary sets of genetic and protein biomarkers that are differentially expressed in specific types of cancer.
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