Quantcast

Industry news that matters to you.  Learn more

Genewiz, Inc. Announces Collaboration with BeiGene, Ltd.

GENEWIZ, Inc., leading global genomics service provider, recently announced a collaboration with BeiGene, a biotechnology company focused on the discovery and development of innovative oncology treatment. The two companies will work together to accelerate cancer biomarker discovery, which will later aid drug target identification.

Headquartered in Beijing, BeiGene has established more than one hundred patient-derived primary tumor models in-house as part of their portfolio of oncology target therapies in early stage development. Utilizing OncoGxOne™ Discovery cancer panels, BeiGene will have the ability to identify and understand genetic variations in prevalent cancers throughout China and the Asia-Pacific region.

“Our collaboration with GENEWIZ and application of the OncoGxOne™ cancer panels will enable characterization of primary tumor models at the genetic level, with a focus on aberrations in cancer related genes,” stated Dr. Lai Wang, Head of Discovery Biomarkers, BeiGene.

“Due to the unique ability to detect aberrations including gene fusions and copy number variance (CNV), using OncoGxOne™ Discovery cancer panels we have capabilities to identify novel mutations present in BeiGene’s primary cancer tumor models,” commented Dr. Guanghui Hu, Vice President of Translational Genomics. “Later, this invaluable information can be used for cancer diagnosis and treatment, which will have a direct impact on patient treatment and quality of life.”

“We believe that this collaboration will strongly support our translational research and biomarker discovery,” asserted Dr. Wang.

Source: Genewiz

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

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

Better Diagnosis of Acute Heart Failure Using Pronota’s Novel Biomarker

Two independent validation studies demonstrate that Pronota’s biomarker CD146 significantly improves the diagnosis of acute heart failure for patients with shortness of breath. The biomarker, measured in blood, provides clinicians with unique additional information allowing better treatment of this challenging group of patients.

Current diagnosis for acute heart failure is limited

Current clinical practice for triaging patients with shortness of breath includes the measurement of specific peptides (B-type natriuretic peptides: BNP or NT-proBNP). Despite the widespread use of these biomarkers, there is still much room for improvement. “Natriuretic peptides have become standard tools to support making the correct diagnosis in patients with shortness of breath. However, clinicians clearly recognize the limitations of natriuretic peptides. The potential value of another biomarker to improve the diagnostic accuracy of BNP or NT-proBNP is considerable,” commented Prof. J. Januzzi (Massachusetts General Hospital, Harvard Medical School).

Pronota’s novel heart failure marker for accurate diagnosis

Pronota identified the biomarker CD146 from an unbiased proteomics effort. Its performance has now been confirmed in two independent studies totaling over 500 patients. Prof. A. Mebazaa (INSERM, Paris, France), principal investigator for the validation studies, commented: “It is exciting to see that novel biomarkers with underlying biological processes completely different from currently used biomarkers can still be discovered and validated. This not only provides more insight into the underlying disease mechanism, it also gives the physician tools to improve the management and care of heart failure patients. Pronota’s approach in this respect is unique and has proven to deliver on numerous occasions.”

Launch forecast: 2014

“Data from early verification and marker characterization studies were already highly exciting, but the recent independent validation studies exceeded our expectations and would not have been possible without the support of our network of key opinion leaders in the field” commented Katleen Verleysen, CEO of Pronota NV. “We anticipate launching this product in 2014, so that clinicians may get access to the tools they need to improve the treatment and care of their patients.”

Source: Pronota

Next-Generation Circulating Tumor Cell Test Demonstrates High Efficiency and Accuracy in New Study

Veridex, LLC (Veridex) recently announced that the first study of the company’s next-generation circulating tumor cell (CTC) technology, developed in collaboration with researchers at Massachusetts General Hospital (MGH), has been published in Science Translational Medicine. The collaboration, initially announced in January 2011, has led to the development of a next-generation CTC (or “liquid biopsy”) technology that offers enhanced specificity and sensitivity and enables more extensive characterization of captured cells.

The new technology tests for CTCs from the blood of cancer patients using advanced microfluidic separation techniques integrated with innovative magnetic sorting to isolate a broad spectrum of rare circulating cancer cells. This technology will allow physicians to get information about a patient’s cancer at the time treatment is being administered, one of the key components to enabling personalized medicine.

Results from the in vitro study showed the integrated system enabled the processing of large blood volumes with high throughput and efficiency, and also allowed for the ability to isolate CTCs from both epithelial and non-epithelial cancers.

In the study, the technology was used to identify the presence of CTCs in patients with cancers of the lung, prostate, pancreas, breast, as well as melanoma.

“Veridex is proud to have introduced CELLSEARCH®, the first and only FDA-cleared CTC test, and we’re excited to work with the team at Massachusetts General Hospital on our next-generation test,” said Nicholas C. Dracopoli , Ph.D., Vice President and Head of Oncology Biomarkers, Janssen Research & Development, LLC. “Together, Veridex and the MGH team bring more than 25 years of experience in rare cell technology to this project. We’re encouraged by the positive results from this study and the potential role this technology may play in helping to advance physicians’ ability to monitor their patients and develop more personalized treatment approaches.”

“These results show the possibility of its use for patients in ‘real time’ as they are receiving treatment. We hope that this next-generation CTC technology will become an everyday tool for doctors treating patients with cancer,” said Mehmet Toner , Ph.D., director of the BioMicroElectroMechanical Systems Resource Center in the Massachusetts General Hospital.

How It Works

The system used two modes of immunomagnetic sorting to isolate CTCs: a positive selection mode to identify and tag target CTCs based on expression of the epithelial surface marker EpCAM (“epithelial cell adhesion molecule”), and a negative selection mode, in which the blood sample is depleted of leukocytes by tagging them with specific antibodies. The test’s ability to isolate CTCs in this manner allows for RNA-based, single cell molecular characterization and expression analysis of CTCs. It will also allow for the test to be used in a broader range of cancers, including cells undergoing epithelial-mesenchymal transition (EMT) and cancer stem cells.

The technology integrates three sequential processes in a single automated system to capture clinically significant CTCs. First, after whole blood samples have been labeled with magnetic beads, the system separates nucleated cells, including CTCs and white blood cells, from red blood cells and platelets with minimal cell loss. Next, the system aligns nucleated cells in a single file within a sorting channel. Finally, the magnetically tagged cells are deflected into a collection channel for identification. These three integrated functions replace the need for separate cell lysis (break down), centrifugation and sorting steps.

About Circulating Tumor Cells

Circulating tumor cells are cancer cells that have detached from the tumor and are found at extremely low levels in the bloodstream. The value of capturing and counting CTCs is evolving as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy.

Study: Inertial Focusing for Tumor Antigen–Dependent and –Independent Sorting of Rare Circulating Tumor Cells

Source: PR Newswire