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QIAGEN Offers Clinical Labs Early Access to New Ingenuity Solution for Streamlined Interpretation of Patient Sequencing Data

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently announced it has begun enrolling molecular diagnostics laboratories in an Early Access Program to complete the development of a new web-based solution to deliver faster, easier-to-use and high-confidence clinical interpretation and reporting of observed gene variants in data from next-generation sequencing (NGS)-based tests. QIAGEN announced the program last month at the annual meeting of the Association for Molecular Pathology (AMP) in Phoenix, Arizona.

Mount Sinai and Exosome Diagnostics Partner to Accelerate Translation of Body Fluid Molecular Diagnostics to Overcome Limitations of Tissue Biopsy in Areas of Critical Unmet Medical Needs

The Icahn School of Medicine at Mount Sinai and Exosome Diagnostics today announced a collaboration on the research and development of real-time nucleic acid-based body-fluid diagnostics to advance personalized medicine. Exosome will provide technical and development support to Mount Sinai researchers along with early access to proprietary technology products upgrades. The agreement will allow Exosome and Mount Sinai to establish targeted research and biomarker discovery programs in oncology, inflammation and other disease areas. Exosome anticipates pursuing commercial development and FDA review of successful validations for in vitro diagnostics.

“This collaboration represents the model that research centers and private companies need to adopt in the post-recession, sequestered economy to develop diagnostic products that can improve clinical outcomes, help advance drug development programs and help lower healthcare costs,” said James McCullough, Chief Executive Officer of Exosome Diagnostics. “New York State has taken an aggressive and appropriate approach to promoting cooperation of its leading research centers, such as Mount Sinai, with private industry resources and commercial capability to drive translational medicine. Mount Sinai and Exosome together can accelerate cutting-edge diagnostic products to serve the clinical market.”

Carlos Cordon-Cardo, MD, PhD, Chair, Department of Pathology, Icahn School of Medicine at Mount Sinai, added, “As we advance our precise medicine program in the Departments of Pathology and Genomics at Mount Sinai, biofluid-based, point-in-time analyses, made possible by the Exosome Diagnostics-Mount Sinai relationship, will undoubtedly lead to an improved, patient-centric understanding of disease, thereby guiding more informed treatment decisions and response to therapy.”

The agreement was negotiated by Mount Sinai Innovation Partners (Mount Sinai IP), which encourages the commercialization of novel research conducted at the Icahn School of Medicine at Mount Sinai. Mount Sinai plans to leverage the considerable expertise of its clinical investigators in areas of key unmet medical needs to develop clinical study programs taking advantage of Exosome’s unique technology that has the ability to extract high-quality RNA from blood, urine and cerebrospinal fluid.

Under the agreement, Mount Sinai will retain rights to molecular biomarkers associated with disease progression and drug response, and Exosome will retain commercial development rights for molecular in vitro diagnostic products. The collaboration will extend for five years. Dr. Cordon-Cardo receives financial compensation from Exosome Diagnostics as a member of its scientific advisory board.

Source: PR Newswire

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

Ignyta Announces Acquisition of Actagene Oncology and Entry into Oncology Personalized Medicine

Ignyta, Inc. recently announced that it has acquired Actagene Oncology, Inc., effective May 20, 2013. Actagene was a San Diego based privately held biotechnology company founded in February 2013 that was developing personalized medicines for high unmet need cancer indications, based on cancer genome mining and sequencing.

Miraculins to License Additional Preeclampsia Technology from Mount Sinai Hospital

Miraculins Inc. (TSX-V:MOM), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today its plans to add to its suite of maternal health biomarkers under license from Mount Sinai Hospital’s Samuel Lunenfeld Research Institute by signing a term sheet to license methods and reagents for detecting hydroxylated Hypoxia Inducible Factor 1 alpha (“HIF-1aOH”), a promising biomarker with potential in differentiating high and low risk pregnancies, including risk of preeclampsia. The technology is part of the pioneering research on preeclampsia and placental development being conducted by Dr. Isabella Caniggia, Senior Investigator at the Samuel Lunenfeld Research Institute, in collaboration with Dr. Martin Post, a Senior Scientist at The Hospital for Sick Children. Dr.Caniggia is also a member of Miraculins’ Scientific Advisory Board and is cross-appointed at the University of Toronto as a Professor in Obstetrics and Gynecology as well as Physiology.

In addition to its promise in maternal health and preeclampsia, HIF-1aOH also presents an opportunity as a cancer biomarker and of further note, the license will include unique monoclonal antibodies highly sensitive to HIF-1aOH and the exclusive rights to manufacture reagents that measure the biomarker using materials developed by Dr. Caniggia. Miraculins is currently advancing a development plan for a kit to detect and measure HIF-1aOHin bodily fluid, which if successful could lead to a near term commercial research use product and allow for more widespread research into the utility of this novel biomarker. The ultimate goal for the biomarker development program would be worldwide sales of the biomarker technology, either alone or in combination with other markers, in a diagnostic kit for the early detection of preeclampsia or as a pregnancy risk assessment tool.

“Since HIF-1a is central to proper placental development, early detection of abnormal HIF-1a regulatory mechanisms could one day provide tools to physicians and caregivers to differentiate high and low risk pregnancies. Although HIF-1a itself is a very promising biomarker, the hydroxylated form may prove to be important to diagnosing the severity of preeclampsia and to better manage this disease throughout pregnancy,” stated Dr. Isabella Caniggia, the discoverer of the markers that comprise Miraculins’ preeclampsia biomarker suite and inventor of the HIF-1aOH technology. “I am very eager to expand our continued work with the Miraculins team to achieve the goal of better outcomes for mothers and babies.”

“We are very pleased to expand our maternal health program and partnership with Dr. Caniggia and Mount Sinai Hospital’s Samuel Lunenfeld Research Institute,” stated Christopher J. Moreau, President and Chief Executive Officer of Miraculins Inc. “This program has been very successful to date, and recently produced a license agreement for the biomarker Endoglin with a major global diagnostic company. We look forward to continuing research into this promising biological pathway with the goal of developing additional preeclampsia diagnostic tools for this devastating disease of growing incidence worldwide.”

Source: Miraculins