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University Hospitals Case Medical Center and Case Western Reserve University Announce Licensing Agreement for the Development of Diagnostic Tests for HIV Drug Resistance

Case Western Reserve University has signed an exclusive worldwide licensing agreement granting University Hospitals (UH) Case Medical Center rights to a series of diagnostic tests to determine drug resistance and co-receptor tropism in human immunodeficiency virus (HIV).

The phenotypic and genotypic HIV tests (or assays) were invented by Eric Arts, PhD, Professor of Medicine in the Division of Infectious Diseases, Department of Medicine at Case Western Reserve School of Medicine, and Miguel Quiñones-Mateu, PhD, Assistant Professor, Department of Pathology at the School of Medicine and Scientific Director at the University Hospitals Translational Laboratory (UHTL, www.uhtl.org).

The HIV assays provide a platform of diagnostic tests used by physicians and researchers to monitor the success of anti-HIV treatment by determining drug resistance and the ability of the virus to infect different cells within the patient. The HIV assays also can be used by academic and corporate researchers to develop novel strategies to block HIV replication.

In July 2011, UH Case Medical Center created the UHTL with the goal of advancing and further developing new molecular diagnostic methodologies originally conceived in the academic and clinical laboratories at UH Case Medical Center and Case Western Reserve. UHTL’s main objective is to facilitate the development of translational research into commercial assays or products, including characterization, verification, and validation in a College of American Pathologists and Clinical Laboratory Improvement Act (CAP/CLIA) certified environment under a Good Laboratory Practice (GLP) framework.

The UHTL occupies 4,200 sq.ft. of office and laboratory space, including BSL-2+, in the Baker Electric Building (MidTown, Cleveland, OH) and was recently CAP accredited. The first series of cell-based and molecular HIV diagnostic tests will be offered by the UHTL during the second quarter of this year.

“The UHTL has provided us with an exciting opportunity to develop new molecular diagnostic tests, and the collaboration of Drs. Quiñones-Mateu and Arts has been particularly fruitful for developing these new tests that will benefit patients by allowing individually targeted selection of therapies for HIV infection,” said Clifford V. Harding, MD, PhD, the Joseph R. Kahn, MD Professor of Pathology and Chair of Department of Pathology, Case Western Reserve and UH Case Medical Center.

“A personalized, four-in-one integrated assay has been launched to provide a highly advanced way to ensure optimal care for HIV infected patients. New collaborations between Case Western Reserve and UH are in process to provide enhanced care for patients with hepatitis and cancer,” said Dr. Arts.

“The UHTL allows UH Case Medical Center to remain on the leading-edge of molecular diagnostic testing. It clearly demonstrates our commitment to our mission: ‘To heal, To teach and To discover,” said Ronald E. Dziedzicki, Chief Operating Officer at UH Case Medical Center. “This new capability will clearly benefit patients with HIV infection in a more targeted manner, thereby impacting the quality of their life. UHTL also provides a platform to assist with the movement of other new and novel testing modalities from a concept to reality. The establishment of this lab and new testing modalities also demonstrates the value of the relationship between UH Case Medical Center and Case Western Reserve University and our quest to improve patient care with new leading edge technologies.”

Dr. Quiñones-Mateu joined UH Case Medical Center as Scientific Director of the UHTL after leading the technical and commercial development of novel molecular and cell-based HIV diagnostic tests at Diagnostic Hybrids, Inc., A Quidel Company. “Our HIV phenotypic (VIRALARTS™HIV and VERITROP™) assays and the novel all-inclusive HIV genotyping and coreceptor tropism test (DEEPGEN™HIV) based on next-generation sequencing will allow us to enhance the care and treatment of HIV-infected individuals not only in Northeast Ohio but nationally as well as worldwide.

DEEPGEN™HIV is a first-in-class assay based on the latest technology developed to rapidly detect variants and mutations in any given genome with high sensitivity. Current tests are able to detect drug resistant viruses with a sensitivity of 20 percent, while DEEPGEN™HIV is able to detect these mutant viruses at frequencies as low as 1 percent. This will give the opportunity to the physicians to “see” the mutant viruses many months in advance and decide whether or not change the treatment before the patient begins to fail HIV therapy.

According to Quiñones-Mateu, “With the collaboration of Dr. Christine Schmotzer, UHTL Medical Director and Assistant Professor of Pathology at the School of Medicine, we are ready to introduce our unique products and services to HIV physicians, pharmaceutical drug companies developing the next generation of effective drugs, and national laboratory service organizations that interact with both groups.”

Source: University Hospitals

Abbott Announces New Test to Help Doctors Determine Personalized Treatment Path for Patients with Hepatitis C

Abbott recently announced that it has introduced the first FDA-approved hepatitis C virus (HCV) genotyping test for patients in the United States. Abbott’s fully automated RealTime HCV Genotype II test determines the specific type or strain (referred to as the genotype) of the HCV virus present in the blood of an HCV-infected individual. Genotyping the HCV virus provides physicians with important information they can use to create a personalized, targeted diagnosis and treatment path to improve clinical outcomes.

“Hepatitis C is known as the silent killer as many of the symptoms go unnoticed. When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective. The introduction of this test for broad use in the U.S. is a significant advancement in helping to address an important public health issue,” said HIV and viral hepatitis expert, Carol Brosgart, M.D., Clinical Professor of Medicine, Division of Global Health, University of California San Francisco.

According to the Centers for Disease Control and Prevention (CDC), more than 75 percent of adults with hepatitis C are baby boomers — born between 1945 and 1965 — and most of them don’t know they are infected. In 2012, the CDC recommended that all baby boomers talk to their doctor and get a one-time test for HCV since this group is five times more likely to have the virus. Once a patient is diagnosed with HCV, a doctor would order a hepatitis C genotype test. The Abbott RealTime HCV Genotype II test is run on the fully automated m2000 platform, which provides laboratories substantial improvements in workflow efficiency to meet the increased demand.

“The Abbott RealTime HCV Genotype II test adds yet another test to the Abbott portfolio for a full spectrum of hepatitis C testing—from ensuring blood supply safety and providing initial screening to enabling targeted diagnoses, identification of the right treatments, and the monitoring of response to therapies,” said John Coulter, vice president, Molecular Diagnostics, Abbott. “Abbott continues to expand diagnostic testing options in the infectious disease area to benefit the healthcare system and enable doctors to improve patient care.”

Source: Abbott

Matrix-Bio Options Metabolite Biomarker Technology from Purdue University to Evaluate Opportunities for New Cancer Diagnostic Tests

Matrix-Bio Inc., a diagnostics company that uses metabolite profiling to detect cancer and other diseases, has signed an exclusive agreement with the Purdue Research Foundation optioning metabolite biomarker technology and eight patent applications to evaluate the commercial potential of cancer diagnostics tests based on the technologies.

The optioned technologies include metabolite biomarkers for detecting esophageal, liver, pancreatic and colon cancer; for identifying liver cancer in patients with hepatitis C; and for predicting preoperative chemotherapy effectiveness for breast cancer treatment. Matrix-Bio’s agreement is for one year with an option to extend the agreement. No other terms of the agreement were released.

The new agreement builds on the existing master license agreement between Matrix-Bio and Purdue Research Foundation for breast cancer biomarkers and metabolite profiling technology developed by Dan Raftery, Matrix-Bio chief scientific officer and founder, while he was a member of the Purdue University research faculty. Raftery is now director of the Northwest Metabolomics Research Center at the University of Washington in Seattle, and is also a member of the Fred Hutchinson Cancer Research Center in Seattle, one of the world’s leading cancer research centers.

Matrix-Bio CEO Eric Beier said the agreement will enable the company to significantly expand its pipeline of cancer detection and monitoring tests, further advancing the company’s leadership in metabolomics-based cancer diagnostic technologies.

“Metabolite profiling is an emerging field of diagnostics that looks at the changes in small molecule biomarkers in cells. Patterns of these metabolite biomarkers in the blood are altered when cancer is present,” Beier said. “Dr. Raftery’s technology identifies metabolic changes with very high sensitivity and specificity, and can detect various cancers in early, more treatable stages more accurately than currently available tests. Studies have also demonstrated that metabolite profiling can assist in monitoring cancer treatment.”

The announcement comes on the heels of an exclusive global licensing and marketing agreement for metabolomic biomarkers Matrix-Bio signed with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services. Under the agreement, Quest Diagnostics has the rights to use the Matrix-Bio biomarkers for the future, potential development of a clinical lab-developed test to aid in the detection of breast cancer recurrence. Quest Diagnostics also has the option to pursue an appropriate regulatory pathway for an in vitro diagnostic version of the test. Additional terms were not disclosed.

Source: Business Wire

Trovagene Announces Commercial Launch Timelines for HPV Carrier and Oncogene Mutation Tests

Trovagene, Inc. (NASDAQ: TROV) recently announced that the development of its proprietary, urine-based HPV carrier screening test is progressing well and the Company expects to achieve analytical and clinical validation of the test in its CLIA laboratory in March 2013. When validation is completed, the test will be available to clinicians and their patients. In addition to the ongoing HPV validation studies, one clinical trial has been completed in India and two additional trials are underway in collaboration with the Barretos Cancer Center, Brazil and Strand Life Sciences, India.

The Company has extended its planned offering of urine-based oncogene mutation tests for 2013 to include a test for the detection of a specific p53 mutation and a specific double mutation in the hepatitis B virus (HBV). Both markers are strongly associated with hepatocellular carcinoma (HCC), which is the third leading cause of cancer mortality worldwide. Availability of the HCC test is anticipated in the fourth quarter of 2013. Trovagene’s KRAS oncogene mutation test is expected to be introduced in the second quarter 2013. In support of the Company’s BRAF oncogene mutation test, a clinical trial with MD Anderson focused on mutations in patients with advanced or metastatic cancers is ongoing. It is anticipated that sufficient clinical specimens will be obtained to support a third quarter offering of this test. Additional clinical studies, including a trial to evaluate the detection of PIK3CA oncogene mutations, are in preparation.

Source: Trovagene

CTC Distributes Data Analysis and Biomarker Platform in Japan

CTC Laboratory Systems (CTCLS) negotiated distribution rights in Japan to Ariana Pharma’s KEM® (knowledge extraction and management) data mining analytics software and services. Originally developed at the Pasteur Institute, KEM is a rules-based (i.e., nonstatistical) data analysis technology for identifying patient-responder sub-populations and biomarker signatures.