May 4, 2015 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
As predicted by Fortune Magazine in its coverage of Theranos, with its expansion into Phoenix, the lab company is getting its closest scrutiny from pathologists and medical technologists
Recent developments in Phoenix, Arizona, make it clear that Theranos has chosen this desert metropolis to be the launching pad for its much-publicized proprietary clinical laboratory testing business.
The highly-secretive company, which claims to have more market value than either Quest Diagnostics Incorporated (NYSE: DGX) or Laboratory Corporation of America (NYSE: LH), is now building the infrastructure needed to operate as a local medical laboratory company in Phoenix.
Theranos Has CLIA Laboratory in Scottsdale
The April 20 issue of The Dark Report presented two exclusive intelligence briefings about Theranos and its business plans. The company now has its “wellness centers” operating in about 41 Walgreens pharmacies throughout the Phoenix metropolitan area. It has opened a clinical laboratory facility in Scottsdale and is currently working to acquire its CLIA certification. When certified, this lab facility will allow Theranos to perform testing locally, eliminating the need to transport all specimens to its CLIA lab in Fremont, California. (more…)
Apr 17, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
Similar study of exome sequencing at UCLA produces findings that mirror the diagnostic outcomes produced by researchers at the three Houston organizations
In recent years, pathologists and other clinical laboratory professionals have seen increasing evidence of the benefits of using exome sequencing for clinical diagnostic purposes.
Confirming their initial published findings of a 25% molecular diagnostic rate, researchers from Baylor College of Medicine (BCM), Baylor Human Genome Center, and the University of Texas Health Science Center at Houston have released results of a large sampling of 2,000 consecutive patients.
In this expanded study, published in the November 12, 2014, issue of the Journal of the American Medical Association (JAMA), 504 patients (25.2%) received a molecular diagnosis and 92 patients (4.6%) benefitted from medical intervention to ameliorate or eliminate negative symptoms. (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
Apr 6, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
However, China has a shortage of well-trained pathologists, which is why some American lab organizations are establishing medical lab testing ventures in China
If experts are right, a company in China is poised to become the world’s largest at gene sequencing. In addition, the huge volume of genetic data it generates is expected to give this company the world’s largest database of genetic information.
Such developments could mean that, in just a few years, many pathologists and molecular Ph.D.s in the United States will be accessing this trove of genetic data as they conduct research to identify new biomarkers or work with clinical specimens.
The company at the center of all this attention is genome-sequencing giant BGI, located in Shenzhen, China. It owns 230 of the largest, high-throughput gene-sequencing machines and wants to become the world’s largest genome-mapping company. (more…)
Mar 27, 2015 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations, News From Dark Daily
Even federal agencies are feeling the consequences of increased transparency as studies uncover serious problems in how data from clinical trials is made available to the public
Increased transparency is coming to clinical trials because of proposed new federal rules. Although the greatest impact will be on drug trials and pharmaceutical research, experts believe that developers of new diagnostic technologies and clinical laboratory tests will benefit as a result of easier access to the public data filed by researchers. Two government agencies published notices announcing their intention to stiffen requirements for greater transparency in clinical trials. The proposed changes are significant for pathologists and medical laboratory professionals because, more stringent requirements for registration and dissemination would make more data from clinical studies available for researchers who develop clinical laboratory tests.
HHS and NIH Publish Notice of Proposed Changes
In November 2014, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM). The same month, its research agency, the National Institutes of Health, announced a draft policy regarding required dissemination of NIH-funded clinical trial information.
The goal of the proposed changes is to ensure that summary results for drugs that fail in trials, or are dropped for other reasons, still make it into the public database, ClinicalTrials.gov, according to a story published in Science.
(more…)
Mar 25, 2015 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Managed Care Contracts & Payer Reimbursement, Management & Operations, News From Dark Daily
Study done by researchers at the University of Washington determined that diagnostic concordance with consensus expert panel missing in nearly 25% of breast cancer cases studied
Standards of quality in clinical care are increasing at a steady pace and anatomic pathology is no exception. The most recent example is the publication of a study in a respected national medical journal that revealed how pathologists participating in the study produced an unexpectedly high rate of diagnostic inaccuracy for certain types of breast cancers.
This situation did not go unnoticed by the national media. On March 17, no less than The New York Times headlined their story on the findings of this story with the title: “Breast Biopsies Leave Room for Doubt, Study Finds.”
(more…)
