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Ventana Receives Approval from China’s FDA for First Fully Automated IHC Companion Diagnostic Identifying ALK Protein Expression in Lung Cancer Patients

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced the approval of the VENTANA ALK immunohistochemistry (IHC) assay by the Chinese Food and Drug Administration (CFDA) as a companion diagnostic to aid in the identification of patients for Pfizer’s CFDA-approved oncology product XALKORI® (crizotinib). The VENTANA ALK (D5F3) Rabbit Monoclonal Primary Antibody assay is designed to identify ALK-positive patients in non-small cell lung cancer (NSCLC) patients1. The approval is based on a retrospective study that included 1100 Chinese subjects across three national hospitals where the VENTANA assay demonstrated 99.23 percent concordance with Abbott’s Vysis ALK Break Apart FISH Probe Kit.

New Test for Cancer Researchers Targets Important Tumor-suppressor Protein

As researchers push to develop more customized diagnostics and therapies for solid tumor cancers, they demand increasingly sensitive tests that offer reliable, reproducible analysis. Spring Bioscience, Inc. (Spring) recently announced a new addition to its specialized portfolio of valuable antibodies for cancer research with the introduction of the Anti-PTEN (SP218) rabbit monoclonal immunohistochemistry (IHC) antibody.

PTEN is a common protein found in most tissues of the body. The protein acts as part of a critical cell signaling pathway that tells cells to stop dividing, helping to prevent uncontrolled cell growth that can lead to the formation of tumors. Mutations in the PTEN gene, together with other factors resulting in loss of PTEN protein, are a step in the development of many human cancers, including prostate and colon cancer. PTEN mutations are also believed to be the cause of a variety of inherited predispositions to cancer.

“With SP218, we’re seeking to set a new gold standard across the industry by offering an extremely sensitive, highly specific antibody optimized for IHC testing that will allow researchers and pathologists to interpret PTEN status with utmost confidence,” says Spring General Manager Michael Rivers. “For our customers, this means we’re continuing to offer unparalleled value through superior tests that lead the market in innovation, reliability and quality.”

Spring internal comparison studies demonstrated that SP218 provides more accurate, sensitive, and specific detection compared to similar research use only (RUO) tests on the market today.

Samples from more than 100 cases of primary prostate and colon cancer showed 100 percent concordance for PTEN loss among Spring’s SP218 and the leading commercially-available PTEN RUO tests; however, competitor tests exhibited some undesirable non-specific staining in IHC testing, while SP218 demonstrated highly specific staining in cells with and without PTEN expression.

“SP218’s robust and consistent performance with IHC analysis is particularly important given PTEN’s potential as a companion diagnostic biomarker,” adds Rivers. “Spring Bioscience is owned by Ventana Medical Systems, Inc., a member of the Roche group, and serves as an Antibody Center of Excellence for Roche’s companion diagnostics development to advance our goal for Personalized Healthcare.”

“Several pharma partners have embraced SP218 as their go-to antibody for PTEN IHC and are including it in their clinical trials as a potential companion diagnostic,” says Doug Ward, VP and Lifecycle Leader, Ventana Companion Diagnostics. “In addition, the Ventana Translational Diagnostics CAP/CLIA Laboratory is now using SP218 as their preferred RUO test for PTEN protein expression.”

Spring is known across the research industry for its quality development practices and for delivering a consistent supply of highly-specific antibodies. SP218 meets the company’s high standards as a valuable tool for assessing PTEN loss.

Source: Spring Bioscience

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

Development of New Technologies Spurs Molecular Diagnostic Test Volumes in Asia-Pacific, Finds Frost & Sullivan

The Asia-Pacific molecular diagnostics market is poised for rapid growth owing to the high prevalence of diseases, increase in the aged population, economic development, and the rising need for better healthcare services. Although several challenges related to cost, regulations and reimbursement policies exist, the market offers immense opportunities for molecular diagnostics vendors.

New analysis from Frost & Sullivan (http://www.lifesciences.frost.com), Analysis of the Asia-Pacific Molecular Diagnostics Market, finds that the market earned revenues of more than US$846.5 million in 2012 and estimates this to reach US$2,528.1 million in 2019.

Public awareness on new, cutting-edge technologies and preventive medicine is increasing in several Asia-Pacific countries. Recognition that molecular diagnostics tests are more accurate, cost-effective, and short turnaround time compare to conventional diagnostics has spurred market growth.

“Newer, automated technologies such as microarrays, Real time PCR technology, mass spectrometric proteomic analyses and protein chips have transformed the way physicians detect and diagnose cancers and genetic diseases at an early stage,” said Frost & Sullivan Healthcare Industry Analyst Gulifeiya Abuduxike. “This has also paved the way for personalized medicine, which can identify the predisposition of a patient to a disease based on genetic variants, and target therapy at the right time.”

While these advanced, automated and integrated technologies widen the application scope of molecular diagnostics, they also lead to high test costs, which a huge section of patients in Asia-Pacific are unable to afford.

The lack of healthcare insurance and reimbursement schemes for diagnostics, usually not considered as important as drugs, further limits adoption in the region. The shortage of skilled technicians and insufficient infrastructure adds to the challenge.

Therefore, clinicians and patients must be educated on the medical value and benefit of molecular diagnostics as well as the need for early detection and preventive medicine. Governments need to establish reimbursements for molecular tests to boost test volumes as well as to reduce the treatment costs.

“Expanding testing menus and application areas, as well as developing automated instruments through research and development are also crucial,” noted Gulifeiya. “Molecular diagnostic companies must look to enhance the accuracy of test results and reduce time consumption.”

As focus shifts to oncology testing, pharmacogenomics and the co-development of companion diagnostics will be key business strategies for Asia-Pacific pharmaceutical companies to maximize the cost-effectiveness of cancer drugs.

If you are interested in more information on this research, please send an e-mail to Donna Jeremiah, Corporate Communications, at djeremiah@frost.com, with your full name, company name, job title, telephone number, company e-mail address, company website, city, state and country.

Analysis of the Asia-Pacific Molecular Diagnostics Market is part of the Life Sciences Growth Partnership Service program. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

Source: Frost & Sullivan

Saladax Receives CLIA Laboratory Certification and Approval to Begin Clinical Laboratory Operations in Support of MyCare Portfolio

Saladax Biomedical, Inc., a privately held company developing novel diagnostic tests that individually optimize a patient’s exposure to chemotherapy, today announced it has been certified as a registered CLIA Laboratory from the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans. The CLIA certification and approval marks a significant milestone for Saladax, allowing the company to begin clinical laboratory operations for the MyCare™ portfolio of products at its facilities located in Bethlehem, PA.

Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, Inc., will initially offer testing services for chemotherapy exposure optimization assays including My5-FU™, MyPaclitaxel™ and MyDocetaxel™ in the U.S. SBL’s menu of testing services will expand to include more than a dozen new exposure optimization tests that are currently in development.

“This is a significant milestone for SBL as our CLIA laboratory operations are at the heart of our U.S. commercialization plan that will include an expanding suite of MyCare exposure optimization tests that we believe give cancer patients the edge they need with their therapy,” said Mark Myslinski, SVP and Chief Commercial Officer at Saladax Biomedical, Inc. “The SBL team did an outstanding job preparing our company for this milestone and it is illustrative of their preparedness for the commercial launch of the MyCare portfolio to oncologists in the U.S.”

Beginning on July 1, 2013, SBL will offer testing services for their initial chemotherapy exposure test portfolio, MyPaclitaxelTM, MyDocetaxelTM and the My5-FUTM test (previously OnDose) that is being transitioned from Myriad Laboratories. The MyCare technology platform offers, rapid, robust and cost-effective blood tests for patient-specific chemotherapy dose optimization.

As a simple blood test, MyCare products will provide oncologists with vital information to determine the optimal chemotherapy dose required to maximize effectiveness and limit toxicity for their patients on an individual basis.

About Saladax Biomedical, Inc.
Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. The company’s proprietary line of MyCare™ assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. The initial focus of Saladax is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. The initial portfolio of three assays is currently offered to the oncology community in markets around the world.

The company’s MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified.

Source: Saladax Biomedical