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Cancer research

Initial Data from PanC-Dx[TM] Non-Invasive Diagnostic Technology Shows Promise in Identifying Malignant Breast Lesions

Strategic Insights

— 2 min read

PanC-Dx[TM] , a non-invasive diagnostic technology developed by OncoCyte Corporation, a subsidiary of BioTime, Inc., demonstrated potential in identifying malignant breast lesions through a large, prospective clinical study. The study, which has nearly completed enrollment of over 600 patients, aims to assess the performance of PanC-Dx[TM] in distinguishing patients with malignant breast lesions from those with negative or benign findings. The technology is based on a proprietary set of cancer markers, including the protein Collagen Type X (COL10A1), which has been shown to be elevated in multiple and diverse malignant tumor types.

Key Takeaways:

  • The study demonstrated the utility of COL10A1 in distinguishing patients with malignant breast lesions from those with negative findings, with a 35% higher mean concentration of COL10A1 protein in sera of breast cancer patients compared to normal individuals.
  • 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 between these two populations.
  • The early data showed improved performance of PanC-Dx[TM] , with 86% area-under-the-curve (AUC) of the Receiver Operating Characteristic (ROC) curve, compared to the commercially available enzyme-linked immunosorbent assay (ELISA) that had an AUC of 74%.
  • The study was presented by Maria Prendes, PhD, Director of Manufacturing at OncoCyte, at the American Association for Cancer Research (AACR) Annual Meeting in 2015.
  • The technology has the potential to detect COL10A1 protein levels with greater sensitivity and specificity than current commercially available assays, making it a promising non-invasive diagnostic tool for breast cancer.
  • OncoCyte is initially focusing its efforts on developing PanC-Dx[TM] diagnostic products for use in detecting breast, bladder, and lung cancers.
  • The company is developing a class of non-invasive cancer diagnostics based on a proprietary set of cancer markers characterized, in part, by broad gene expression patterns in numerous cancer types.
  • The PanC-Dx[TM] biomarkers were discovered as a result of ongoing research within OncoCyte and BioTime on the gene expression patterns associated with embryonic development.

Statistics:

  • Over 30 million screening mammograms were performed in the U.S. alone in 2010 (Source: American Cancer Society).
  • The National Cancer Institute estimates that approximately 20% of all breast cancers are not detected by mammography during annual screening (Source: NCI).
  • The American Cancer Society and the National Comprehensive Cancer Network recommend screening mammography every year starting at age 40, which has been associated with a relative reduction in breast cancer mortality of 15% to 20% (Source: American Cancer Society).
  • PanC-Dx[TM] 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).

Sources:

  • American Association for Cancer Research (AACR) Annual Meeting
  • OncoCyte Corporation
  • BioTime, Inc.
  • National Cancer Institute (NCI)
  • American Cancer Society
  • National Comprehensive Cancer Network

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