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Ventana Receives FDA Clearance for Estrogen Receptor (ER) Image Analysis and Digital Read Application for Breast Cancer

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Companion Algorithm ER (SP1) image analysis algorithm used with the VENTANA iScan Coreo scanner running Virtuoso software. With this clearance, Ventana is now the only company in the industry offering a comprehensive portfolio of FDA-cleared image analysis algorithms and digital read applications for the five key immunohistochemistry (IHC) breast markers.

BioTime’s Subsidiary OncoCyte Corporation Publishes Data on the Gene FSIP1 as a Breast Cancer-Specific Marker

BioTime, Inc. (NYSE MKT: BTX) and BioTime’s subsidiary OncoCyte Corporation recently announced the publication of a scientific report on the gene FSIP1 and its potential as a marker for breast cancer. The paper, published in the peer-reviewed journal Biomarkers in Medicine and available online today, describes the microarray-based approach used to identify FSIP1 as a breast cancer biomarker with significantly elevated expression in breast tumors expressing the estrogen receptor, which represents 70-80% of all breast cancers. In addition to elevated gene expression, FSIP1 protein was also expressed within tumors at significant levels whereas little to no expression was found in most normal tissues, including healthy breast tissue. Combined, these findings lay the foundation for novel diagnostic and therapeutic strategies, including the measurement of FSIP1 in the blood as a screen for the presence of cancer, as well as targeting of FSIP1 as an antigen in cancer immunotherapy approaches.

Based on large unmet need, market size, and data generated thus far from patient sample screening, OncoCyte is initially focusing its efforts on identifying biomarkers that may be used to detect and monitor breast and bladder cancers. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies for use in detecting breast cancer, in preparation for the initiation of the first clinical study of PanC-DxTM and is currently working with a select group of cancer researchers to finalize a study protocol for submission to the institutional review boards of the study sites. If clinical trials are successful, OncoCyte intends to launch PanC-DxTM as an in vitro diagnostic (IVD) in Europe before seeking FDA approval required to market PanC-DxTM in the United States.

ColoMarker: Convenient, Low-cost, Early Stage Colon Cancer Blood Test Reports Validation

EDP Biotech, the US-based developer of a blood test to detect the early stages of colon cancer called ColoMarker™, recently announced its plans to commercialize the product and bring the new technology to market. Unlike other diagnostic tests currently in development, the ColoMarker test detects a level of CA11-19 antigen, a specific protein molecule found in the bloodstream. While every human being produces this protein, elevated levels in the bloodstream suggest the presence of colon cancer.

Recent third party validation of ColoMarker™, demonstrating test accuracy of 95 percent, has positioned EDP Biotech to pursue market launch in the near future. To EDP’s knowledge, no other routine sandwich ELISA technology identifies 95 percent of early stage colorectal cancer in blood.

EDP Biotech has partnered with Corgenix Medical Corporation to manufacture ColoMarker™. Corgenix is a world leader in the development and manufacturing of specialized diagnostic kits for more than 20 years. EDP is also aggressively pursuing CE Mark and fully anticipates approval and subsequent commercialization in Europe by the end of this year, followed by a strategic path towards FDA approval.

“We developed ColoMarker because of the critical need to detect cancer at its earliest stages,” says Tom Boyd, CEO of EDP Biotech. “This validation confirms that our technology has strong potential to save thousands of lives each year through early stage detection, and it’s our goal to make it available to diagnostic oncology labs and accessible to medical professionals throughout the world.”

ColoMarker™ has proven to be effective in identifying elevated levels of a biomarker in the bloodstream in 95 percent of early stage colorectal cancers, when the disease is most treatable and survival rates are highest. To date, physicians have relied primarily on colonoscopies and fecal occult blood testing (FOBT) to identify potential cases of early stage colon cancer.

A critical part of EDP Biotech’s research and development of the ColoMarker technology has been the involvement and consultation of some of the world’s most recognized experts in this field:

  • Dr. Gene Overholt – inventor of the scope for colonoscopies and recognized worldwide as the “father of the colonoscopy”
  • Dr. Herbert Fritsche – one of the world’s leading experts on cancer biomarkers and former Chief of Clinical Chemistry at MD Anderson Cancer Center
  • Dr. John Costanzi – internationally-known and considered a leading expert in the treatment of cancer

Recently Dr. Donald Wheeler – author, professor, statistician and renowned quality control expert – also joined EDP Biotech’s scientific advisory board as the company approaches commercialization.

Source: Business Wire

Advanced Cell Diagnostics Initiates Agreement to Study Biomarkers for Cancer Immunotherapy

Advanced Cell Diagnostics, Inc. (ACD) announced today that they have entered into an agreement with The Johns Hopkins University on behalf of its Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins to use ACD’s proprietary RNAscope® technology platform to validate novel biomarkers and drug targets for cancer immunotherapy.

Cancer immunotherapy, which aims to mobilize a patient’s immune system to fight cancer, has been gaining momentum recently with the FDA approval of anti-CTLA-4 therapy for melanoma and with the recent impressive and durable remissions produced by targeting PD1 in multiple solid tumors in early-phase clinical trials led by Johns Hopkins investigators. With many additional immune modulatory molecules identified for targeting that play major roles in specific subsets of cancer, it will be critical to develop standardized biomarkers to guide the application of the most effective immune therapies on a patient by patient basis.

Targeting the immune checkpoints that are often suppressed in many cancers has demonstrated tremendous potential. However, to identify biomarkers useful for guiding therapy, conventional approaches to biomarker analysis have proven inadequate, leading to conflicting results.

“The complex interplay between cancer cells and the immune system in the tumor microenvironment matches perfectly with RNAscope’s capability of single molecule sensitivity and single cell resolution, which can help pinpoint which cell is talking to which other cell,” said Dr. Yuling Luo, Founder, President and CEO of ACD. Dr. Luo added, “That knowledge will be essential for selecting optimal targets for drug development and predicting which patient will benefit from it. We feel extremely fortunate to be able to provide such a tool to the pioneers in this emerging and exciting field.”

Source: Advanced Cell Diagnostics

Verastem Enters Biomarker Agreement with LabCorp for Cancer Stem Cell Agent Companion Diagnostic

Verastem, Inc., (NASDAQ: VSTM) a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, entered an agreement with Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) to validate biomarkers for its lead focal adhesion kinase (FAK) inhibitor VS-6063 in the development of an applicable companion diagnostic.