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Archives for June 2013

Empire Genomics Licenses Novel DNA Biomarker for Use in Diagnosing and Creating a Companion Diagnostic Test for Neuroendocrine Prostate Cancer

Empire Genomics recently announced that it has acquired an exclusive license for a patent pending novel genomic biomarker from Cornell University for use in developing a molecular diagnostic test that could help in diagnosing and determining treatment for patients with neuroendocrine (NEPC) prostate cancer.

Neuroendocrine prostate cancer (NEPC) is a lethal variant of prostate adenocarcinoma (PCA) that can arise de novo, but more commonly arises after hormonal therapy for PCA. Little is known about the underlying molecular biology of NEPC or how and why some patients with PCA progress to a predominantly neuroendocrine phenotype. There is currently no effective therapy for NEPC, and most patients survive less than one year. The poor molecular characterization of NEPC accounts in part for the lack of disease specific therapeutics.

“Each year, approximately, 30,000 men will die of advanced prostate cancer, most of whom will be treated with androgen suppression therapy, however, it is impossible to know just how many of them developed NEPC because patients are not typically biopsied at that stage of their disease,” said Dr. Brian Kelly , Director of Technology Commercialization and Liaison at the Weill Cornell Medical College office of the Cornell Center for Technology Enterprise and Commercialization (CCTEC). “We are delighted that Empire Genomics is now going to make this important diagnostic test available to this patient population and we look forward to working with the company and its seasoned management team.”

“We are delighted to work with Empire Genomics to help develop a commercial grade assay to test for abnormalities one of the key driving genes of the most aggressive form of prostate cancer. This clinical tool will be important as we move forward with precision medicine clinical trials for aggressive castration resistant prostate cancer lead by Dr. Himisha Beltran,” said Mark Rubin , Homer T. Hirst Professor of Pathology in Oncology and the Director of the Institute for Precision Medicine.

Empire Genomics will launch a genetic test for NEPC that will diagnose NEPC Prostate Cancer later this year and seek to partner with pharmaceutical companies to use this assay for accelerating patient stratification in clinical trials.

“We are very pleased to work with Drs. Rubin and Beltran and Cornell to commercialize this technology,” said Anthony Johnson , CEO of Empire Genomics. “It is another exciting genomic tool that we have added to our exclusive precision medicine portfolio.”

Source: Empire Genomics

Mayo Clinic Forms Joint Venture with Cancer Genetics

Mayo Clinic and Cancer Genetics Inc. (OTCQB: CGIX) recently launched OncoSpire Genomics, a joint venture with the singular goal of improving cancer care by discovering and commercializing diagnostic tests that leverage next-generation sequencing.

“Individualized medicine and genomic testing give us a fundamental understanding of the inner workings of wellness and disease. We recognize the transformative power of these tools and are committed to using every resource at our disposal to bring individualized medicine to our patients,” says Gianrico Farrugia, M.D., a Mayo Clinic gastroenterologist and director of Mayo Clinic’s Center for Individualized Medicine. “That is why this joint venture is so important.”

OncoSpire will focus on mutually identified projects in the Biomarker Discovery Program within Mayo’s Center for Individualized Medicine. Initial focus areas will include hematological and urogenital cancers, and potentially other cancers, as selected by a scientific review committee. OncoSpire will be based in Rochester and will be equally owned by Cancer Genetics and Mayo Clinic. Cancer Genetics will contribute operating capital, commercial expertise and other guidance. Mayo will contribute in-kind with sequencing and laboratory resources, clinical and research expertise, and other operational resources. Financial details of the agreement were not disclosed.

“We expect this new venture to accelerate cancer biomarker discovery research already underway at Mayo Clinic Cancer Center,” says Robert Diasio, M.D., cancer researcher and director of the Mayo Clinic Cancer Center. “Transforming discoveries into individualized cancer therapies will benefit patients, so we are excited to be part of these efforts.”

Research will be conducted in genetics and life sciences labs at Mayo Clinic, including Mayo’s Center for Individualized Medicine Biomarker Discovery Program and the medical genome facility, a resource that allows medical researchers to investigate how individual differences in the structure and function of human genomes influence health outcomes.

Technological advances, such as next-generation sequencing, have driven down the cost to perform whole genome sequencing. What originally took $3 billion over 13 years for the Human Genome Project and the first human genome sequence now can be accomplished for a few thousand dollars in a matter of days.

Panna Sharma, CEO of Cancer Genetics, says: “The combination of resources we are bringing together positions OncoSpire Genomics to create a major impact in the development of advanced genomic-based cancer diagnostics. Our investment in OncoSpire Genomics represents the potential for the paradigm shift in patient management that can result in more efficient use of health care resources, ultimately improving the cost structure of cancer diagnosis and treatment. We expect this will add value to our commercial offerings as next-generation sequencing becomes more widely accepted by the clinical community. A major factor behind our decision to work with Mayo was the depth of their world-class clinicians and thought leaders, who we believe are in a position to drive clinical value and clinical adoption for the tests being created by OncoSpire Genomics.”

Mayo Medical Laboratories and Mayo Clinic’s Department of Laboratory Medicine and Pathology will work with Mayo’s Center for Individualized Medicine to help bring discoveries from the joint venture to patients at Mayo Clinic and elsewhere. According to Frost & Sullivan, a health care industry analyst, the U.S. cancer biomarker testing market is expected to reach $11.5 billion by 2017.

“Next-generation sequencing will change the future of health care, especially in complex disease categories such as cancer,” says R.S.K. Chaganti, Ph.D., founder and chairman of Cancer Genetics. “We are pleased to have forged this new relationship with Mayo with the goal of furthering next-generation sequencing technologies. Cancer Genetics’ strength in hematological and urogenital cancers brings a tremendous knowledge base to the partnership. Together we can make a significant impact in the pursuit of personalized medicine that is transforming cancer treatment.”

OncoSpire has formed a scientific review committee, which is composed of six researchers, thought leaders and clinicians.

Source: Mayo Clinic

Biomarker Predicts Organ Rejection and Death in Heart Transplant Patients

Critical Diagnostics announced recently the recently-published results of a Utah Transplantation Affiliated Hospitals Cardiac Transplant Program study involving the use of a novel biomarker, ST2, to monitor heart transplant patients for rejection. Subjects with the highest levels of ST2 had a more than 3-fold increase in the risk for death than those with the lowest ST2 levels. Moreover, this risk was present early and sustained from the time of initial blood draw to many years forward.

Just over 45 years ago, on December 3, 1967, Dr. Christian Barnhard transplanted the first human heart into 53-year old Lewis Washkansky, a South African grocer dying of chronic heart disease. After his surgery, Washkansky was given drugs to suppress his immune system, but they also left him vulnerable to deadly infections. He died 18 days later from double pneumonia.

Medicine has come a long way since then. Worldwide, over 3,500 heart transplants are performed annually, more than half in the U.S. Post-transplant survival rates now average 15 years, yet rejection and death are still all too common.

Currently, biopsy-driven diagnoses are used to predict transplant organ rejection, but this type of procedure is costly, involves risk, and offers little consideration of the underlying biological processes that predict the presence or severity of rejection and/or likelihood of adverse consequences.

In the ST2 study (“Interleukin receptor family member ST2 concentrations in patients following heart transplantation”), a total of 241 transplant patients were followed for a period of just over 7 years, during which time there were 62 deaths, or some 25 percent. The prognostic ability of ST2 was examined for both rejection and death. ST2 concentrations were measured approximately a month after transplantation and found to be highly predictive of short-, intermediate-, and longer-term outcomes.

“A monitoring strategy for the rejection that directly relates to its underlying pathophysiology would be an attractive choice,” notes the study authors. “Biomarkers reflective of rejection are an option . . . a novel biomarker candidate worthy of consideration for this application is ST2.”

Study: Interleukin receptor family member ST2 concentrations in patients following heart transplantation.

Source: Critical Diagnostics