Sep 23, 2015 | Instruments & Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Antibody validation standards would help ensure reproducibility of research studies and improve the consistency medical laboratory test results
As science and industry gets better at measuring things and assessing quality, the acceptable standard often comes into question. This seems to be happening with antibodies, the most common reagents used in diagnostics, clinical laboratory diagnostic tests, and medical research. In many cases, the end result is that companies and their suppliers must use new technologies and quality methods to revise the “old way” and create products that have measurable better quality.
The techniques currently used to validate antibodies is the topic of a recently-published scientific paper. The authors of a paper published in the March, 2010, issue of Biotechniques pointed out, antibody validation and standardization ensure study reproducibility, which is critical to accuracy. And yet, no standard guidelines define how these important biological tools should be validated prior to use.
Thus, researchers participating in a recent webinar, presented by The Scientist expressed concern that—without improved antibody validation and standardization—the accuracy of published research is in question and diagnostic test results, such as those produced by medical laboratories, will continue to be inconsistent. (more…)
May 13, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Wyss Institute develops prototype Ebola test in less than 12 hours with $20 in materials, perhaps paving the way for inexpensive paper-based diagnostic tests with a wide range of applications outside the medical laboratory
One goal of many synthetic biology researchers is to create in vitro diagnostic testing systems that produce results that are as accurate as those produced in today’s state-of-the-art clinical laboratories, yet are much cheaper to run because they incorporate low-cost materials, such as paper.
Recently, two teams of researchers worked to demonstrate how several synthetic biology methods, when combined with programmable paper-based diagnostic platform, could detect antibiotic-resistant bacteria and strain-specific Ebola virus. These findings were published in a peer-reviewed medical journal last fall.
Such cell-free circuits embedded in paper could be the breakthrough in synthetic biology that leads to pocketsize blotter tests that can detect such diseases as Ebola in the field. Should this line of research be applied to clinical settings, pathologists and medical laboratory scientists could soon be processing bandages that change colors in the presence of certain bacteria, or examining paper-based clothing infused with diagnostic laboratory tests that react to bio-markers specific to a chronic disease patient’s condition. (more…)
Apr 15, 2015 | Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Emerging field of translational medicine expected to contribute to more informative studies that provide superior data for making medical decisions
These are boom times for translational medicine. That’s the term used to describe how the health of individuals and the community can be improved through applying new knowledge into diagnostic tools (including medical laboratory tests), medicines, procedures, policies, and education.
Rapid developments in the field of translational medicine include a role for pathologists who are discovering and validating molecular biomarkers associated with diseases.
Pathologists Have a Role in the Science of Translational Medicine
Translational medicine was the centerpiece in an interview conducted with an expert in biomedical research. Translational medicine is “where unproven observations advance to increasingly large and more informative studies to provide definitive and comparative information for a medical decision in routine clinical practice” contended Biomedical Consultant John Sninsky, Ph.D., former Vice President of Discovery Research at Alameda, California-based Celera Diagnostics. He was quoted in an interview published by GenomeWeb.
In validating translational medicine findings, Sninsky noted that everyone (e.g. pathologists, clinical laboratory scientists, and medical technologists) who contribute to the process must “weigh and balance” information so that it’s not used prematurely, but also not delayed when it has been proven useful to medical decisions. “So, in the end, no one piece of information, whether it be the conventional diagnostic test or the new test, will suffice for medical decisions, but will require gathering and reflecting on as much of the information as possible,” added Sninsky.
Large-scale Studies Better Sources for Personalized Medical Data
The goal of “personalized medicine” is for doctors to be able to prescribe treatments that more effectively “target” their patients’ unique physiologies and conditions. How to best conduct research and interpret the findings in ways that advance clinical care is under debate, as experts address the issues of individualized care versus population management.
What makes translational medicine relevant to pathologists, clinical chemists, and other clinical laboratory scientists is that this field of science is already changing how research studies and clinical trials are designed and conducted. Experts knowledgeable in this field predict that the principles of translational medicine will support important improvements.
First, these methods will be used to design clinical studies that are less expensive and faster to complete. Second, when such studies are conducted in this fashion, there will be a faster timeline between publication of findings and acceptance by providers, payers, and patients. Both improvements have the potential to directly benefit clinical labs as they develop new medical laboratory tests, conduct the clinical studies needed to demonstrate patient benefits, and then clear regulatory requirements needed to bring these new diagnostic assays to market.
The best method for gathering that data, however, is in question, noted Sninsky. He thinks large-scale studies are a better source for accumulating the needed data than research on individuals. “If you identify personalized medicine as information that’s truly unique to an individual, we actually think that information applicable to segments of the population will prove more timely and more important,” stated Sninsky, who then added, “we think that maybe calling it ‘targeted medicine’ rather than personalized medicine makes the case in point.”
Biomedical Consultant John Sninsky, Ph.D. (pictured above), former Vice President of Discovery Research at Alameda, California-based Celera Diagnostics, said in an interview with GenomeWeb that Targeted Medicine is more descriptive of where disease management is heading, rather than Personalized Medicine, because gathering information on a segment of the population is more straight forward than gathering information on an individual. (Photo copyright Celera Diagnostics)
Sninsky pointed out that validation and demonstration of utility only comes with replication in large studies. Therefore, in order to be effective, he suggested that applicable information would usually address about 10% of the population, “so disease management or health management, in the context of targeted medicine, is the way we think about it.”
Role of Clinical Laboratories in the Accelerated Development of In Vitro Diagnostic Assays
According to Sninsky, the natural progression and availability of diagnostics won’t change much. Large clinical reference laboratories will continue to create laboratory-developed assays. These “home-brews” will then evolve into FDA-approved in vitro diagnostic products that get distributed to “lower-throughput” clinical laboratories.
Sninsky further observed that sometimes these “smaller service laboratories” end up offering the assays as a [clinical] service after they’re launched. This accelerates the assay’s development as an in vitro product, he said, noting that the advantage of in vitro diagnostic products over services is their widespread availability.
NIH Support for Translational Medicine Steps Up FDA Regulatory Process
Sninsky acknowledged that getting biomarker-based molecular diagnostics validated and cleared through the Food and Drug Administration (FDA) and into the hands of physicians continues to be an onerous process. The FDA, however, has taken steps to accelerate the process, which Sninsky welcomes.
“One of the things I think is really good news is the stand that the U.S. regulatory agency has taken in terms of saying we’re going to help this process along,” he noted. “If someone would have said to me 15 years ago that the FDA was going to be leading the charge of the application of biomarkers, I would have been pessimistic about that.”
Since launching its Experiential Learning Program (ELP), the FDA’s Center for Devices and Radiological Health (CDRH) has accelerated the pre-market approval rate of medical and diagnostic devices, which includes in vitro diagnostic products.
Support for advancing the translational medicine approval process was demonstrated by the National Institutes of Health (NIH) in 2011 with the establishment of the National Center for Advancing Translational Sciences (NCATS). NIH also recently launched a Precision Medicine Initiative that aims to use genetic data from individuals to personalize diagnostic and therapeutic strategies. This $215 million project is pending Congressional approval of the President’s 2016 budget. (See Dark Daily, “Obama’s $215 Million Precision Medicine Initiative: Will Congress Fund It and Can It Advance Genetic Testing and the Value of Clinical Laboratory Services?”, March 23, 2015.)
Clinical Laboratories Provide the Diagnostic Tests for Physicians
While the clinical laboratories that run these tests do help in the development and wider distribution of in vitro diagnostic assays, Sninsky believes that caregivers, health plans, and patients have a greater role in demonstrating clinical effectiveness. “What our experience has been is it’s not the clinical labs who will decide whether new biomarkers are used, but instead will be the practicing clinicians, the reimbursement agencies, and the patients who see value in them that will make those decisions,” concluded Sninsky.
–Patricia Kirk
Related Information:
‘Targeted Medicine’: New Name of the Game
Obama’s $215 Million Precision Medicine Initiative: Will Congress Fund It and Can It Advance Genetic Testing and the Value of Clinical Laboratory Services?
Weill Cornell and New York Presbyterian to Create New Precision Medicine Institute to Use Genome Sequencing to Individualize Cancer Treatment
FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups
FDA Approving Devices Faster
FDA Presents Plans to Ensure the Reliability of Laboratory-Developed Diagnostic Tests
NIH and FDA Join Forces to Advance Translational Medicine and Regulatory Science
FDA Expands Its Internal Program to Learn More from Companies about Medical Device Manufacturing
Sep 3, 2014 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs
After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs.
If the federal agency wanted to get the full attention of the clinical laboratory industry, it certainly succeeded. In the four weeks since the FDA alerted Congress of its plans for LDT regulation, there has been a flood of national news stories about this development. (more…)
