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MediSapiens Expanding Rapidly into Precision Medicine and Genomic Diagnostics

Earlier this year MediSapiens announced a joint venture with International Cancer Advocacy Network (ICAN) to develop and publish Remission Coach®, a web-based solution that addresses the urgency of cancer management.  This innovative solution provides cancer patients with a personalized platform for actively determine the most appropriate clinical trial for that patient’s disease and treatment history. Now MediSapiens announces collaboration with Genoscoper Laboratories, leading animal DNA diagnostics laboratory.

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.

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

Regional Cancer Care Associates (RCCA) and GenPath Oncology Announce Diagnostic Laboratory Partnership to Benefit Nearly a Quarter Million NJ Cancer Patients

Regional Cancer Care Associates LLC (RCCA), one of the nation’s largest oncology physician groups, announced today it has partnered with GenPath Oncology (www.genpath.com), a business unit of BioReference Laboratories to bring advanced diagnostics to the practice’s more than 230,000 cancer patients.

RCCA and GenPath have joined together to create an advanced molecular laboratory on the grounds of the John Theurer Cancer Center in Hackensack, NJ. This initiative expands the group’s offered services into key diagnostic testing for their patient community. The first step in this multi-year partnership is the development of a physician-owned immunophenotyping service for hematological malignancies. In addition, GenPath will also be providing a significant amount of esoteric diagnostic testing to RCCA’s network of 92 oncology physicians in 27 locations.

The partnership with GenPath will strengthen RCCA’s mission to raise the standard of cancer care across the state, while remaining competitive in a changing healthcare environment where medical practices increasingly face declining reimbursements and rising administrative costs.
“We recognize that providers are forming larger practices to meet the challenges of a changing market. BioReference continues to adapt as our clients evolve. RCCA and BioReference both share a commitment to patient care and support scientific innovation for this purpose,” said Marc D. Grodman, M.D., President and CEO of BioReference Laboratories.

“RCCA was established to offer the highest quality and most comprehensive cancer care and our partnership with BioReference expands upon that goal. Through this relationship, RCCA is well positioned to offer the most innovative cancer diagnostics,” said Edward J. Licitra, M.D., Ph.D. and Board Chairman of RCCA.

RCCA is one of the nation’s largest oncology physician networks. As a group, RCCA is transforming healthcare, by providing a broad range of quality cancer services to patients while also controlling the cost of patient care through practice-management consistency, more competitive contractual rates and hospital privileges, resulting in long-term savings for payers. The new RCCA testing service, scheduled to begin in June, will focus on providing timely and clinically-relevant results for patient care in a cost effective manner.
According to Licitra, oncology is at a crossroads—increasing longevity in the population has the unintended effect of raising the incidence of cancer. “Oncology care is advancing, becoming more specialized and therefore getting more expensive. Over time, some cancer care may become unaffordable, and that would be tragic. We need to take steps now that allow us to modulate the growth of the cost of cancer care while maintaining quality,” he explained.

GenPath, headquartered in Elmwood Park, was selected from among the largest cancer laboratories in the nation, due to its scientific expertise and longstanding relationships with many of RCCA’s physicians. GenPath offers oncology providers a single source for cancer patient management, including bone marrow morphology, solid tumor diagnosis, molecular genetics for personalized medicine, and even routine clinical testing specific for cancer patients. In addition, GenPath offers two innovative proprietary testing modalities, OnkoMatch, a tumor genotyping test that covers more than 100 possible mutations in 14 clinically targetable oncogenes, and GenArray which scans a patient’s entire genome for chromosomal abnormalities, offering superior coverage over conventional methods such as FISH and cytogenetics.

Source: PR Newswire