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OncoCyte Announces Initial Data From Ongoing Clinical Study of Collagen Type X as a Marker and Potential Diagnostic for Breast Cancer and Other Types of Human Cancers

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BioTime, Inc. (NYSE MKT:BTX) and its subsidiary OncoCyte Corporation recently announced initial data from a large, prospective clinical study that showed the potential of PanC-Dx™, OncoCyte’s non-invasive diagnostic technology based on its proprietary set of cancer markers, as a non-invasive, blood-based diagnostic test to screen for multiple types of human cancers, including breast cancer. The early data showed the utility of the protein Collagen Type X (COL10A1) in distinguishing patients with malignant breast lesions from those with negative findings. The clinical data was presented by Maria Prendes, PhD, Director of Manufacturing at OncoCyte, at the American Association for Cancer Research (AACR) Annual Meeting during a poster presentation from 8:00 AM -12:00 PM EDT on Monday, April 20, 2015.

The controlled study, initiated at Scottsdale Medical Imaging Laboratories in Scottsdale, AZ, is ongoing and has nearly completed enrollment of over 600 patients. The goal of this study is to assess the performance of PanC-Dx™ in discriminating patients with malignant breast lesions from those with negative findings or benign findings. Study investigators are collecting blood samples from patients undergoing screening or diagnostic mammography. Patient blood samples are being assessed for levels of OncoCyte’s PanC-Dx™ markers, including the concentration of the protein COL10A1, using proprietary assays and the results are compared to radiological and pathology findings. Expression of the gene COL10A1 at an mRNA level has been shown in past studies to be significantly elevated in multiple and diverse malignant tumor types including cancers of the breast, stomach, colon, lung, bladder, pancreas, and ovaries. In addition, the protein was shown to be specifically localized within tumor vasculature.

Early data showed that PanC-Dx™ identified a mean concentration of COL10A1 protein in sera of breast cancer patients (n=33) that was 35% higher than the mean COL10A1 value in sera of normal individuals (n=32). No significant differences were noted when comparing breast cancer patients to patients with confirmed benign disease suggesting that additional biomarkers may be necessary to discriminate these two populations. Based on this data, PanC-Dx™ offered improved performance as compared to the commercially available enzyme-linked immunosorbent assay (ELISA) manufactured with polyclonal antibodies that study investigators previously used in analyzing over 400 serum samples from healthy volunteers and cancer patients. Evaluation of the performance of PanC-Dx™ demonstrated 86% area-under-the-curve (AUC) of the Receiver Operating Characteristic (ROC) curve, which determines the level of specificity and sensitivity of the product. The polyclonal ELISA demonstrated 74% AUC of the ROC curve.

“These early data suggest the potential of PanC-Dx™ and COL10A1 protein as a blood-based diagnostic and biomarker that could prove useful in non-invasive, early detection of a wide variety of cancers, including breast cancer,” said Joseph Wagner, PhD, OncoCyte’s Chief Executive Officer. “We are excited by the opportunity of developing PanC-Dx™ as a simple, radiation-free alternative for breast cancer detection for millions of women whose dense breast tissue makes their mammograms less accurate. Study investigators are testing other markers in the same patient samples that could increase accuracy for breast cancer detection. In addition, we are encouraged by the potential for PanC-Dx™ to detect COL10A1 protein levels with greater sensitivity and specificity than current commercially available assays.”

In 2010 over 30 million screening mammograms were performed in the U.S. alone. The American Cancer Society and the National Comprehensive Cancer Network both recommend screening mammography every year starting at age 40, which has been associated with relative reduction in breast cancer mortality of 15% to 20%. However, the NCI estimates that approximately 20% of all breast cancers are not detected by mammography during annual screening, which indicates that there is an unmet need for a breast-cancer screening test with superior specificity and sensitivity when compared to standard screening mammography.

Source: BioTime