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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.

Mount Sinai and Exosome Diagnostics Partner to Accelerate Translation of Body Fluid Molecular Diagnostics to Overcome Limitations of Tissue Biopsy in Areas of Critical Unmet Medical Needs

The Icahn School of Medicine at Mount Sinai and Exosome Diagnostics today announced a collaboration on the research and development of real-time nucleic acid-based body-fluid diagnostics to advance personalized medicine. Exosome will provide technical and development support to Mount Sinai researchers along with early access to proprietary technology products upgrades. The agreement will allow Exosome and Mount Sinai to establish targeted research and biomarker discovery programs in oncology, inflammation and other disease areas. Exosome anticipates pursuing commercial development and FDA review of successful validations for in vitro diagnostics.

“This collaboration represents the model that research centers and private companies need to adopt in the post-recession, sequestered economy to develop diagnostic products that can improve clinical outcomes, help advance drug development programs and help lower healthcare costs,” said James McCullough, Chief Executive Officer of Exosome Diagnostics. “New York State has taken an aggressive and appropriate approach to promoting cooperation of its leading research centers, such as Mount Sinai, with private industry resources and commercial capability to drive translational medicine. Mount Sinai and Exosome together can accelerate cutting-edge diagnostic products to serve the clinical market.”

Carlos Cordon-Cardo, MD, PhD, Chair, Department of Pathology, Icahn School of Medicine at Mount Sinai, added, “As we advance our precise medicine program in the Departments of Pathology and Genomics at Mount Sinai, biofluid-based, point-in-time analyses, made possible by the Exosome Diagnostics-Mount Sinai relationship, will undoubtedly lead to an improved, patient-centric understanding of disease, thereby guiding more informed treatment decisions and response to therapy.”

The agreement was negotiated by Mount Sinai Innovation Partners (Mount Sinai IP), which encourages the commercialization of novel research conducted at the Icahn School of Medicine at Mount Sinai. Mount Sinai plans to leverage the considerable expertise of its clinical investigators in areas of key unmet medical needs to develop clinical study programs taking advantage of Exosome’s unique technology that has the ability to extract high-quality RNA from blood, urine and cerebrospinal fluid.

Under the agreement, Mount Sinai will retain rights to molecular biomarkers associated with disease progression and drug response, and Exosome will retain commercial development rights for molecular in vitro diagnostic products. The collaboration will extend for five years. Dr. Cordon-Cardo receives financial compensation from Exosome Diagnostics as a member of its scientific advisory board.

Source: PR Newswire

Clarient, A GE Healthcare Company, Introduces First Lab Developed Test To Assess Multiple Proteins at Single-Cell Level

GE Healthcare recently announced the introduction by Clarient Diagnostic Services, a GE Healthcare Company, of the first lab developed test using MultiOmyx™, a ground-breaking new pathology platform which uses proprietary methodology to assess multiple proteins from a single tissue section at a single-cell level. This test, now available, offers an aid to a pathologist’s diagnosis of CD30-positive lymphoma cases with difficult morphology or otherwise insufficient tissue to adequately evaluate the case.

“In many instances, suspected lymphoma cases are not straightforward, and sample tissue size inadequacy issues further complicate the matter,” said Lawrence Weiss, MD, Medical Director of Clarient. “In difficult to call diagnoses, MultiOmyx gives me great confidence in making the diagnosis and relieves me from the concern of running out of tissue. If I only have a small amount of tissue, I do not have to sacrifice or choose between important markers – I can assess them all.”

The Hodgkin Lymphoma (HL) Profile by MultiOmyx helps to assess nine unique antibodies (CD30, CD15, CD20, CD45, PAX5, OCT2, BOB1, CD3, and CD79A) on a single formalin fixed paraffin embedded tissue section to aid in differential diagnosis of Classical HL.

In clinical validation, this single slide assay called the Hodgkin Lymphoma Profile by MultiOmyx demonstrated high levels of accuracy, diagnostic reproducibility and repeatability, and high sensitivity of all immunofluorescent stains in comparison to traditional immunohistochemistry performed on the same samples. The correlation study identified unique cases where MultiOmyx demonstrated improved performance.

“Traditional pathology uses multiple slices from paraffin-fixed tumor samples and examines them slide by slide, which is less efficient and effective,” said Carrie Eglinton Manner, CEO, Clarient. “Using a single slide may save time, uses significantly less tissue and may provide a more consistent result. Since different parts of a tumor sample can act differently and because less tissue is required, pathologists can access the most accurate and broad tumor analysis available, while eliminating today’s need to prioritize tests due to limited tissue availability.”

The relevance of the MultiOmyx technology was recently confirmed in a clinical paper written by a team of scientists from GE Global Research published in Proceedings of the National Academy of Sciences (PNAS). The paper details the different ways GE is using image data to visualize cancer and the relationship between different biomarkers and the tumor environment and suggests the technology could be broadly applicable to problems in basic biological research, drug discovery and development and companion and clinical diagnostics.

“MultiOmyx provides clinicians and researchers with a novel biomarker multiplexing method to understand biological context in a way that is not possible with other technologies that disrupt the tissue histology. Once cells are removed from the context of their overall microenvironment with other methods valuable information is lost,” said Christine Kuslich, PhD, Chief Science Officer, In Vitro Diagnostics, GE Life Sciences. “MultiOmyx uniquely facilitates the ability to visualize multiple biological pathways, local immune response as well as heterogeneity of expression within regions of interest on a cell-by-cell basis from a single tissue section maintaining tissue context.”

The platform uses fluorescence to provide quantitative analysis of antibodies and allows for up to 60 proteins to be examined on a single tissue sample. It creates a “digital map” of the tumor, giving each cell an “address” and allowing for a clear graphic representation of protein expression. Matching this map to known biosignatures gives researchers a more accurate representation of the exact characteristics of the tumor and may provide clinicians with a clearer view to aid the diagnosis. It also allows them to identify patterns in the tissue by analyzing each cell and biomarker individually, or as a cluster, and thus get a level of understanding of the biological process that could not be achieved via traditional methods.

Study: Highly multiplexed single-cell analysis of formalin-fixed, paraffin-embedded cancer tissue

Source: Business Wire

Luminex Corporation Receives U.S. FDA Clearance for MAGPIX® Instrument with Novel xTAG® Gastrointestinal Pathogen Panel

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). This is the first clinical assay to be cleared on MAGPIX. xTAG GPP is the first U.S. IVD cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.

Venaxis Advances Pivotal U.S. Study and Accelerates European Market Development for APPY1 Blood-based Appendicitis Test

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its rapid, protein biomarker-based appendicitis test, APPY1, today provided an update on its clinical and commercial activities. The Company continues to enroll patients into its ongoing pivotal U.S. clinical study of APPY1, as well as make strong progress on its European market development initiatives.

Steve Lundy, Chief Executive Officer of Venaxis, commented, “We identified a number of significant milestones for 2013 and during the recent months have begun achieving them, including initiation of our pivotal study for APPY1, which we anticipate, upon completion, will support filing for regulatory clearance with the FDA. We also obtained CE Marking for APPY1, and we commenced an initial launch of the product for market development purposes in Europe. As we expected, 2013 has been characterized so far by continued progress on these critical initiatives. We are encouraged by our successful execution to date and we plan to remain focused and diligent so that we can reach the important milestones to come.”

Enrollment into the APPY1 pivotal U.S. clinical study is expected to continue across the 28 participating hospital sites throughout much of 2013. Based on current projections, the Company anticipates completing the study and potentially filing with the FDA for regulatory clearance of APPY1 by year end 2013.

Following CE Marking of APPY1 in January, Venaxis successfully executed market development agreements with MOSS S.p.A., which is based near Milan, to cover Italy; Istanbul-based SAVAS Medikal Inc. to cover hospitals in Turkey; and Netherlands-based EMELCA Bioscience, covering hospitals in the Benelux countries. Pursuant to these agreements, strategic market development activities have commenced those regions and Venaxis anticipates announcing additional agreements in the near term that cover the additional targeted EU territories.

The Company also strengthened its balance sheet with an underwritten public offering in late 2012, for which Venaxis received approximately $4.7 million in total gross proceeds, including full exercise of the underwriter’s over-allotment option. The Company ended the year with $12.1 million in cash, cash equivalents and short-term investments, which Venaxis believes is sufficient to complete the ongoing U.S. pivotal trial, as well as advance the market development activities in Europe.

Mr. Lundy concluded, “We have emerged successfully from 2012 as a pure-play in vitro diagnostics company with sufficient capital to advance our new and innovative diagnostic product that we believe fulfills an important need in the emergency care market. As study enrollment continues to ramp in the U.S. and we continue to gain traction and gather market intelligence in Europe, we look forward to providing timely updates on our key achievements.” 

Source: Venaxis