Quantcast

Industry news that matters to you.  Learn more

Biodesix Launches GeneStrat Targeted Liquid Biopsy Mutation Test For Patients With Advanced Lung Cancer

Biodesix, Inc. recently announced the launch of GeneStrat™, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer (NSCLC). The blood test results are available within 72 hours, providing physicians actionable diagnostic information prior to making treatment decisions. GeneStrat is focused exclusively on the clinically actionable EGFR, KRAS, and BRAF mutations often used to guide targeted therapy treatment decisions. GeneStrat also captures the EGFR T790M mutation, which can be used for monitoring the emergence of the primary resistance mutation in the EGFR gene. It is anticipated that two drugs targeting the resistance mutation may be available later this year. GeneStrat uses the ddPCR platform to analyze cell-free tumor DNA and is highly concordant with tissue analysis, currently considered the gold standard.

Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG CYP2C19 Kit

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

Fluidigm and Olink Bioscience Bring a New Level of Protein Biomarker Discovery to the Life Science Research Market

Fluidigm and Olink Bioscience have teamed up to enable interrogation of 96 samples across 92 proteins in a single run from one microliter of sample in less than a day.

The two companies will co-market the combination of their respective products — Fluidigm’s BioMarkTM HD System and Olink Bioscience’s Proseek® Multiplex technology — bringing protein research to the Fluidigm platform and Olink Bioscience’s protein detection assays to the high-throughput, high reproducibility and unparalleled sensitivity realm of Fluidigm’s real-time PCR system.

Fluidigm’s BioMark HD System and Olink Bioscience’s Proseek Multiplex technologies provide researchers with the highest throughput multiplexing solution for protein biomarker discovery in the market today. Typically, researchers are limited to working with a few tens-of-protein biomarkers at a time. Using the BioMark HD System with the Proseek Multiplex Oncology I 96×96 Kit, a researcher can simultaneously analyze 96 human samples against a panel of 92 analytes, such as growth factors, inflammatory markers, soluble receptors, or cancer antigens. With the addition of four control analytes (two incubation controls, and extension and detection controls), researchers can now obtain results for up to 9,216 reactions in just a few hours.

The first 92-plex Olink panel, available now, is focused on biomarker discovery for cancer. Panels addressing cardiovascular disease and inflammation are expected to be offered later this year.

“Protein research is so important because these biomarkers are used to monitor health states and predict treatment outcomes in patients. One of the biggest trends in the life sciences industry today is research to uncover biomarkers that can lead to companion diagnostics,” said Simon Fredriksson, Olink Bioscience president and chief executive officer. “Conventional immunoassays have been unable to scale due to increasing antibody cross-reactivity when more and more assays are run simultaneously. Olink’s Proseek Multiplex generates high quality data even in highly multiplexed formats, and using these assays in conjunction with Fluidigm’s BioMark HD System gives protein researchers easy access to unprecedented volume and quality of data.”

The Olink Bioscience assay provides a signal when pairs of antibodies equipped with DNA reporter molecules bind to their targets to create new DNA amplicons. The amplicons are subsequently quantified by high throughput real-time PCR. With PCR’s large dynamic range and superb sensitivity, in combination with Olink Bioscience’s unique protein detection assays, the opportunities are enormous for powerful analysis of multivariate biomarker patterns.

“Analyzing 92 proteins from one microliter of sample enables new biomarker discovery and validation,” said Gajus Worthington, Fluidigm president and chief executive officer. “Many sample sources, including those from biorepositories or model organisms, are limited, and researchers can simply run out before they are able to find useful biomarker panels. The combination of Fluidigm’s BioMark HD System and Olink’s Proseek Multiplex assay represents a robust new tool for the protein research community.”

Fluidigm’s BioMark HD System is a multi-application genomics and proteomics platform that provides results equivalent to the gold standards for every respective experimental approach. The system produces high-quality data from RNA, miRNA and DNA from sample sizes down to the single cell level — and now extends to proteins. The BioMark HD System performs analysis of protein expression, gene expression, copy number variation, SNP genotyping, and digital PCR.

Olink Bioscience’s Proseek Multiplex is a multivariate protein biomarker detection kit based on Olink’s proprietary Proximity Extension Assay (PEA). It uniquely allows multiplexing of immunoassays without compromising assay performance. PEA uses pairs of oligonucleotide-labeled antibodies equipped with DNA reporter molecules to bind to proteins of interest in a highly specific manner, solving the antibody cross-reactivity dilemma that plagues and limits conventional protein assays.

Source: Business Wire

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