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Protagen AG Launches Landmark First Research Test Kit for Systemic Sclerosis

Protagen AG, a company dedicated to the development of powerful diagnostic tools to address some of the most severe autoimmune diseases, recently launched its first ELISA research use test kit for Systemic Sclerosis (SSc), the ADx®SSc Multilisa®. Protagen developed the new assay to synergistically combine two proprietary, novel disease markers with two standard diagnostic markers to support medical research in autoimmune diseases.

Minomic to Register MiStat ELISA Prostate Cancer Test for CE Mark Approval

Australian biotechnology company Minomic International Limited will register its MiStat(TM) ELISA prostate cancer test for CE Mark approval in the latter part of 2014.

Nuclea Bio Acquires Oncogene Science, Extends Deal with Wilex

Just a few months after announcing several new partnerships and landing venture capital dollars, Nuclea Biotechnologies Inc. has snapped up Oncogene Science, an Cambridge, Mass.-based subsidiary of Wilex AG in Germany.

Sony DADC Develops Smart Consumables for Quanterix Simoa HD-1 Analyzer

Quanterix Corporation, delivering the world’s most sensitive single molecule immunoassay measurement for the benefit of human health, recently announced that the Simoa HD-1 Analyzer recently launched by Quanterix uses a “Smart Consumable” designed and manufactured by Sony DADC BioSciences called the Simoa Disc. For use in life science research today and in vitro diagnostics (IVD) markets in the future, the Simoa disc is used to achieve higher levels of sensitivity and precision and is the first diagnostic consumable whose assay technology is based on optical disc formats by Sony DADC.

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