DARK Daily Laboratory and Pathology NewsDARK Daily is an e-briefing service providing up-to-the minute news of relevance for anyone working in diagnostic medicine, from clinical laboratories and pathology groups to lab industry suppliers and diagnostic technology companies. DARK Daily is part of The Dark Intelligence Group, Inc. and is dedicated to bringing useful business and management intelligence to laboratory managers, pathologists and diagnostic executives. Our recognized expertise in the strategic direction of laboratory medicine and the management of laboratories is available through DARK Daily, The Dark Report, free White Papers, Lab Resource Directory, the Executive War College on Laboratory and Pathology Management, Lab Quality Confab, and strategic consulting services.
Paper Microfluidic Devices Offer New Potential for Affordable Point-of-Care Tests for Use in Developing Countries That Have Few Clinical Laboratories
Paper-based devices could perform complex, multistep diagnostic tests at a fraction of the cost of traditional medical laboratory analysis
Many research teams are racing to create paper-based devices for medical laboratory tests. Their primary goal is develop a cheap, fast, reliable way to perform diagnostic testing in third world settings, where modern clinical laboratories are few and far between. One development team is working to combine lab-on-a-chip technologies with the low cost of paper-based platforms.
Meanwhile, over the past decade, point-of-care testing (POCT) has revolutionized diagnosis and treatment options for a myriad of conditions. In developing regions or remote areas, low-cost POCT improves accessibility to vital tests for infectious diseases, such as HIV, Malaria, and Ebola, as well as acute medical conditions, such as sepsis.
In the past eight years, Dark Daily has reported many times on the emergence of new POCT devices. From lactic acid screening to the lab-in-a-needle, which is used for detecting liver toxicity, the ability to produce a quick and accurate diagnosis without intensive clinical laboratory testing is growing.
However, one area where many POCT devices face challenges is in surviving extended environmental exposure. This does not pose an issue in major research hospitals or health systems. However, the consequences can be severe when considering the often harsh, resource-limited conditions of developing countries—one area in which POCT stands to offer the greatest value. continue reading
Study Finds FDA Relied on Flawed Data When Approving High-Risk Medical Devices for Obstetrics and Gynecology; Are There Implications for Regulation of LDTs?
Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market
Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance.
One example involves researchers at the Northwestern University Feinberg School of Medicine. They recently determined that the U.S. Food and Drug Administration (FDA) based approvals of certain medical devices on flawed data.
Announced in a May 2016 statement, the study, which was published in the journal Obstetrics and Gynecology, will be of special interest to clinical laboratory executives and pathologists who understand that the findings of this study might be useful ammunition in the medical lab industry’s efforts to forestall FDA regulation of laboratory developed tests (LDTs).
Essentially, if these researchers can find obvious flaws in how the FDA reviews a relatively limited number of medical devices, as identified by this study, then how would the FDA cope with the need to review thousands of LDTs in a timely, cost-effective, and rigorous manner? continue reading
Secret Meeting Between Scientists and Thought Leaders at Harvard to Discuss Creating Synthetic Human Genome Sparks Controversy; Were Pathologists in Attendance?
The idea that human beings could be created without biological parents sounds like the stuff of science fiction, but it’s not, and the technology could be available in the not so distant future
It’s not known how many pathologists and clinical chemists were in attendance at a secret meeting that took place in Boston in May, which was organized to investigate the feasibility of building a synthetic human genome.
Nearly 150 scientists, lawyers, entrepreneurs, and ethicists met in a closed-door session at Harvard Medical School to discuss creating a synthetic human genome. Although this meeting was secret, people took notice. The possibility of using a synthetic genome to create human beings—without biological parents—understandably caused concern among the life science communities, the New York Times reported, and the apparent secrecy fueled speculation that ignited controversy, which spread rapidly. continue reading
Good News for Honest Clinical Laboratories: Federal Fraud Case in New Jersey Brings More Convictions and Indictments of Doctors Who Accepted Illegal Inducements
Biodiagnostic Laboratory Services fraud case continues to bring more criminal convictions of physicians in a rare case of tough federal enforcement of anti-kickback laws
There’s good news for sales representatives who work for clinical laboratories and anatomic pathology groups and regularly run up against the sales practices of shyster labs that offer inducements to that class of doctors who are open to personal enrichment by accepting different forms of kickbacks in return for lab test referrals.
The good news comes from New Jersey, where one U.S. attorney has prosecuted dozens of doctors who accepted various illegal inducements and bribes from BioDiagnostic Laboratory Services Inc. (BLS) of Parsippany, the discredited lab company that was closed in 2012 after it was indicted by Paul J. Fishman, the U.S. attorney for Newark.
The most recent conviction was announced in April, 2016, when another New Jersey physician pleaded guilty in the continuing clinical laboratory fraud case involving BLS.
Gary Safier, MD, pleaded guilty to taking bribes in excess of $350,000 over a period of seven years. He was sentenced to two years in prison and, upon release, will have to perform an additional two years of supervised release. He was also instructed to forfeit the $353,000 he received for his role in the scam. continue reading
Can Medical Laboratories Tell Patients There’s No Need for Overnight Fasting before a Cholesterol Test? Denmark’s Experience Says Answer is ‘Yes!’
Comparing results from more than 300,000 individuals, international experts recommend using non-fasting blood screening for most cholesterol and triglyceride tests
Every clinical laboratory offering cholesterol testing across the globe must deal with a common issue: because patients are told to fast overnight before giving a blood specimen, patient service centers (PSCs) and blood collection centers are overcrowded when they first open their doors in the morning. That’s because hungry patients want their sample collected so they then go eat something as soon as possible.
It has long been recognized that the overnight fasting requirement for collecting blood samples used in cholesterol testing is unpleasant for patients. It also adds cost to the healthcare system because labs must staff an adequate number of phlebotomists in their PSCs to handle the predictable early morning rush of hungry patients wanting to be done with this task. Meanwhile, in the afternoons, patient traffic in the same PSCs can dwindle to near nothing, leaving phlebotomists in those PSCs with little to do. continue reading
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