Quantcast

Industry news that matters to you.  Learn more

Archives for April 2013

Third-generation Device Significantly Improves Capture of Circulating Tumor Cells

A new system for isolating rare circulating tumor cells (CTCs) – living solid tumor cells found at low levels in the bloodstream – shows significant improvement over previously developed devices and does not require prior identification of tumor-specific target molecules. Developed at the Massachusetts General Hospital (MGH) Center for Engineering in Medicine and the MGH Cancer Center, the device rapidly delivers a population of unlabeled tumor cells that can be analyzed with both standard clinical diagnostic cytopathology and advanced genetic and molecular technology. The MGH team’s report has been published in Science Translational Medicine.

“This new technology allows us to follow how cancer cells change through the process of metastasis,” says Mehmet Toner, PhD, director of the BioMicroElectroMechanical Systems Resource Center in the MGH Center for Engineering in Medicine, the paper’s senior author. “Cancer loses many of its tissue characteristics during metastasis, a process we have not understood well. Now for the first time we have the ability to discover how cancer evolves through analysis of single metastatic cells, which is a big step in the war against cancer.”

The new device – called the CTC-iChip – is the third microchip-based device for capturing CTCs developed at the MGH Center for Engineering in Medicine. The first two systems relied on prior knowledge of a tumor-specific surface marker in order to sort CTCs from whole blood and required significant adjustment for each different type of cancer. The systems also required four to five hours to process a single blood sample.

The only U.S. Food & Drug Administration-cleared, commercially available device for capturing and enumerating CTCs – the CELLSEARCH® system developed by Veridex, LLC – relies on magnetic nanoparticles that bind to the same epithelial protein used in the MGH -developed microchip-based devices and cannot always find CTCs present at very low numbers. In January 2011 the MGH entered into a collaborative agreement with Veridex and its affiliate Janssen Research & Development, LLC, to establish a center of excellence in research on CTC technologies.

Combining elements of both approaches – magnetic labeling of target cells and microfluidic sorting – the CTC-iChip works by putting a blood sample through three stages. The first removes from the sample, on the basis of cell size, all blood components except for CTCs and white blood cells. The second step uses a microfluidic process developed at the MGH to align the cells in a single file, allowing for extremely precise and rapid sorting. In the third stage, magnetically labeled target cells – either CTCs tagged via the epithelial marker or white blood cells tagged on known blood-cell antigens – are sorted out. Tagging white blood cells instead of CTCs leaves behind a population of unlabeled and unaltered tumor cells and doesn’t rely on the presence of the epithelial marker or other known tumor antigens on the cell surface.

The new system was able to process blood samples at the extremely rapid rate of 10 million cells per second, handling a tube of blood in less than an hour. Both the mode of sorting out tagged CTCs, called tumor-antigen-dependent, and the technique that depletes white blood cells, called tumor-antigen-independent, recovered more than 80 percent of tumor cells from different types of cancer that had been added to blood samples. Comparison of the antigen-dependent-mode CTC-iChip with existing commercial technology for processing blood samples from patients with prostate, breast, pancreatic, colorectal and lung cancer showed the CTC-iChip to be more sensitive at detecting low levels of CTCs.

In the antigen-independent mode, the CTC-iChip successfully identified CTCs from several types of cancers that had lost or never had the epithelial marker, including triple-negative breast cancer and melanoma. CTCs isolated through this mode were put through standard cytopathological analysis, which revealed structural similarities to the original tumor, and detailed molecular genotyping of CTCs from a single patient found significant differences in gene expression patterns among individual CTCs.

“We’re only beginning to identify potential applications of the ability to analyze how tumors mutate as they spread, but this should help improve our understanding of the fundamental genetic principles of metastasis,” says Toner, the Benedict Professor of Surgery at Harvard Medical School (HMS). “We hope to develop this technology to the point where it could be used for early diagnosis, which is the ‘Holy Grail’ that all of us working on CTC technology have been striving for.”

Ravi Kapur, PhD, of the Center for Engineering in Medicine, leader of the innovation team within the MGH Circulating Tumor Cell Center, says, “The CTC-iChip provides a first-in-class device for high-efficiency, high-speed tumor cell sorting from a clinically relevant blood volume. The chip is designed for mass manufacturing, and simple automation for clinical translation.” The team is working with collaborators at Veridex and Janssen to refine the system for commercial development.

Study co-author Daniel Haber, MD, PhD, director of the MGH Cancer Center and Isselbacher/Schwartz Professor of Oncology at HMS, adds, “The study of cancer metastasis has been limited by the inability to quickly and reliably isolate tumor cells in transit in the blood. This new approach is likely to be a game changer in the field.”

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

Source: EurekAlert!

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

NCQA to Test Pioneering Way to Measure Quality, Foster Wider Use of Prevention Strategies

The National Committee for Quality Assurance (NCQA) and the Robert Wood Johnson Foundation (RWJF) recently announced a new approach to measuring quality that will provide a more sensitive gauge of risk factors and make it possible to create clinically meaningful incentives for providers to improve disease prevention.

Under a grant from RWJF, NCQA will evaluate a new measurement tool that focuses on improving the health outcomes of patients with heart disease and diabetes. The “Global Cardiovascular Risk” (GCVR) score, which is being co-developed by NCQA and Archimedes, Inc., is the “next generation” quality improvement tool that measures how well providers reduce the risk of future adverse outcomes—such as heart attacks, strokes, and diabetic complications—in the populations they serve. GCVR is also a powerful new use of electronic health records (EHRs), drawing upon clinical information from EHRs to provide the data needed to assess improvement in preventing bad outcomes.

“This new tool has the potential to become the first customized, outcomes-based electronic health record measure used by Medicare and commercial payers,” says NCQA President Margaret E. O’Kane. “Its widespread adoption could have a profound impact on health care costs because it assesses how well providers engage in prevention and goal-setting for their high-risk patients. We believe it could become the new gold standard of quality measurement, replacing some traditional measures that have been the cornerstone of quality improvement for years.”

The traditional approach to quality measurement focuses on processes of care, and reaching clinically artificial treatment goals for biomarkers, rather than the actual disease outcomes. Traditional approaches provide little quantitative information about the outcomes that actually occur based on the care patients receive. In contrast, the GCVR measures how much patients’ risk of future adverse health outcomes have been reduced. Unlike current measures, which focus on a particular process or biomarker, the GCVR measure is a single metric that captures what every provider can do to prevent adverse outcomes, all integrated in a medically and clinically realistic way.

Under the project, NCQA will:

  • Evaluate the feasibility of collecting data from EHRs to calculate a measurable result for different providers and provider organizations; and
  • Evaluate provider views on how useful and meaningful the GCVR score is for predicting risk.

“The GCVR program will change how providers, patients, and payers think about the measurement of quality and will provide much more accurate and effective incentives for preventing adverse outcomes than has been possible in the past,” says David Eddy, MD, PhD, founder of Archimedes Inc., a San Francisco-based healthcare modeling company. “Preventing bad outcomes is the ultimate purpose of the health care system, and this measure will directly address that goal,” he says. “And because bad outcomes cause expensive admissions, tests, and procedures, this new measure will be more effective in controlling costs, at the same time that it helps improve patients’ lives.”

“The GCVR is a game-changer for measuring quality, promoting prevention, and assessing the impact of health care decisions on patient outcomes,” says RWJF President and CEO Risa Lavizzo-Mourey, MD. “Measuring quality in this way could have major implications for improving patient care and lowering costs because this is focused on preventing adverse health outcomes, not just on care processes or goals, which has been the standard until now.”

Over the next 18 months, NCQA will evaluate the feasibility of extracting the electronic health data it needs to calculate the measure from a number of health systems and health plans that use EHRs from around the country. It is now in the process of recruiting organizations to participate. The data collection and analysis will occur over the summer and fall of 2013, and NCQA expects to report findings by summer 2014.

Watch the video A Pioneering Way to Measure Health Care Quality in which Helen Darling of The National Business Group on Health discusses how the GCVR will benefit employers.

Source: Robert Wood Johnson Foundation

GE Healthcare Launches its First “Next-Generation” Sequencing Assay

GE Healthcare recently announced that Clarient Diagnostic Services, Inc., a GE Healthcare company, will begin offering a next-generation sequencing assay focused on solid tumor targets for use in clinical trials. This assay will empower researchers to perform prospective and retrospective analysis to better understand which patients will respond to particular therapies, to help stratify patient populations for ongoing clinical trials, and to aid early research efforts.

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.