New diagnostic capabilities could enable clinical laboratories to obtain multiple outcomes on single fluidic strip tests
Researchers at the University of Rhode Island (URI) have developed a paper-based microfluidic valve technology that some claim may revolutionize existing lateral-flow tests. There is the potential for this innovation to eventually enable pathology groups and medical laboratories to conduct a wide variety of complex medical diagnostics on single fluidic test strips, such as those used to diagnose pregnancy and strep throat, according to a university statement.
Testing Multiple Biomarkers Using a Single Test Strip
Fluidic test strips commonly in use today are generally capable of rendering only one result. However, by combining their new paper-based valve platform with standards strip tests, the URI research team has produced strip tests capable of answering more challenging medical questions.
The evolution of the new technology, dubbed “Lab-on-Paper,” follows the development of the team’s earlier “lab-on-a-chip” device, which the researchers began developing back in 2005. (more…)
Pathologists and clinical laboratory managers can expect to see an expansion of genetic testing in the wake of the Supreme Court’s decision in the Myriad case
Pathologists and clinical laboratory professionals got a major victory on June 13. That’s when the United States Supreme Court (SCOTUS) ruled 9-0 to end the 30-year-old practice of awarding patents on human genes. The unanimous decision invalidates certain hotly contested patents held by Myriad Genetics, Inc., (NASDAQ: MYGN) on the BRCA1 and BRCA2 genes.
Moreover, this Supreme Court decision also opens the doors to other medical laboratories to develop their own diagnostics around the BRCA genes and compete for breast-cancer testing market share. (more…)
Nanosphere’s Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) gives pathologists and clinical laboratory managers a new tool in the diagnosis of septicemia
One of the more challenging diseases to diagnose and treat is septicemia. Traditional microbiology methods typically require two or three days before an accurate diagnosis can be made. Now there is news of a rapid test for bloodstream infections that can allow a hospital clinical laboratory to deliver an answer to physicians in as little as two hours.
It was just last week when the Food and Drug Administration LINK (FDA) granted a de novo petition to allow Nanosphere, Inc., of Northbrook, Illinois, to market its Gram Positive Blood Culture Nucleic Acid Test (BC-GP). This assay is design to be run on Nanosphere’s Verigene automated system. Because the time-to-answer is as little as two hours, this diagnostic technology has the potential to trigger swift changes in the current standard of care for diagnosing and treating blood infections.
Adoption of EHR systems by small practices, small hospitals, and rural health providers lags behind the pace of urban-based hospitals and physician groups
As larger numbers of physicians implement electronic health record (EHR) systems, clinical laboratories are faced with the task of building interfaces that connect their laboratory information systems (LIS) to those EHRs.
Recent numbers indicate that hundreds of thousands of physicians are now enrolled in the federal EHR incentive program. This puts medical laboratories and anatomic pathology groups squarely in the midst of the drive to encourage physicians to both implement an EHR in their clinical practice and use that EHR in ways that meet “Meaningful Use” requirements.
Some 225,765 providers are participating in the Medicare and Medicaid EHR incentive programs created by the American Recovery and Reinvestment Act of 2009. The Centers for Medicare and Medicaid Services (CMS) report that almost $4.5 billion in financial incentives have been paid to hospitals and physicians for implementation of electronic health record (EHR).
Business Intelligence software now allows for real-time data capture, analysis and evaluation of medical laboratory operations
For clinical laboratories and anatomic pathology groups across the nation, the latest use of middleware is for business intelligence. This is a brand-new trend, as only first-mover and early adopter medical laboratories have acquired and currently use some type of middleware solution that delivers business intelligence.
One-by-one, laboratory informatics companies are crafting middleware products specifically designed to deliver business intelligence to their customers and clients. Business Intelligence (BI) is a computer-based approach to collecting and analyzing business data. A flurry of activity in the laboratory informatics sector reinforces the importance of health IT and healthcare analytics in an increasingly competitive medical laboratory testing market. (more…)