Put It on the Board, 3/16

Thomas Wheeler, MD, testified in defense of the pathologist whom Carswell sued initially. Dr. Wheeler, chair of the Department of Pathology and Immunology at Baylor College of Medicine, is more sanguine about the case’s potential consequences.

“I don’t think it will have any significant impact for pathologists,” he says. “It may have some [impact] for health care entities that are brought into a case and are attempting to be shielded by the tort reform law. But for pathologists, I think the precedents are there that the performance of autopsy is the practice of medicine.”

The Texas Society of Pathologists is “watching the case closely,” society president Kevin Homer, MD, tells CAP TODAY. “Texas pathologists…understand well that the performance of an autopsy is the practice of medicine. It requires a Texas medical license and years of postgraduate training in pathology. The Texas Supreme Court’s determination as to whether it meets the legal standard of ‘health care’ will likely turn on the court’s analysis of several factors, including Texas citizens’ strong desire to limit lawsuits and attract more physicians to the state.” —Kevin B. O’Reilly
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ConfirmMDx added to NCCN guidelines

MDxHealth SA announced that its ConfirmMDx for Prostate Cancer test has been included in the 2016 National Comprehensive Cancer Network Guidelines.
“Inclusion in the guidelines establishes ConfirmMDx as a ‘standard of care’ for the management of men at risk for undetected prostate cancer,” MDxHealth CEO Jan Groen, PhD, said in a statement. “This is the second MDxHealth test to be included in the NCCN guidelines, with PredictMDx for Glioblastoma added in 2013, and illustrates our commitment to delivering clinically valuable solutions to improve patient outcomes.”
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Higher-throughput FilmArray system cleared

The FDA has given 510(k) clearance to BioFire Diagnostics’ new FilmArray platform, which has a smaller footprint and provides six times more sample throughput compared with the existing system. The new system, called FilmArray Torch, has been cleared for use with the FilmArray Respiratory Panel. BioFire has submitted 510(k) applications for Torch to be cleared for use with its gastrointestinal, meningitis/encephalitis, and blood culture identification panels.
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CE for BD blood separation technology

Becton, Dickinson has obtained the CE mark for a next-generation blood separation technology that is designed to enhance sample quality, improve laboratory efficiency, and reduce laboratory turnaround time.

The BD Vacutainer Barricor tube is a single-use, plastic evacuated tube used to collect, separate, transport, and process venous blood specimens to obtain high-quality plasma for in vitro diagnostic use. The tubes are optimized to deliver a high-quality plasma sample by reducing cellular content (versus plasma gel tubes), as a result of the mechanical separator remaining open throughout the centrifugation cycle. It is designed to eliminate gel artifacts that can lead to instrument downtime. With no clotting time required, the BD tube can cut centrifugation time by up to seven minutes and reduce overall turnaround time by as much as 37 minutes, BD said.
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Most DTC genetic results not shared with doctors

Direct-to-consumer genetic testing may create unrealistic expectations for patients and a conundrum for physicians who largely feel unprepared to discuss test results, says a recent study. Using data from the Impact of Personal Genomics Study, a large, longitudinal study of actual users of 23-
andMe and Pathway Genomics DTC genetic tests, researchers described the characteristics and perceptions of consumers who shared their results with their doctor or another health professional (van der Wouden CH, et al. Ann Intern Med. Published online ahead of print March 1, 2016. doi:10.7326/M15-0995).

The researchers found that 27 percent of consumers shared their genetic test results with their primary care physician, and most of those who did were satisfied with the discussion of results. For the minority who were unsatisfied with the physician encounter, the physician’s inability to adequately answer the patients’ questions and concerns could be to blame. The authors suggest that patient perceptions and expectations may influence their attitudes. They say that given the increasing importance of genetic concerns in primary care, physicians should be trained to at least engage in a discussion about these tests.

The authors of an accompanying editorial suggest that deceptive marketing messages create unrealistic expectations about the health benefits of at-home genetic tests (Burke W, et al. Ann Intern Med. Published online ahead of print March 1, 2016. doi:10.7326/M16-0257). They call upon the health system to counter unrealistic marketing messages with real advice for consumers.

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Blue Cross covers Sequenom tests in California

Sequenom has completed an agreement with Anthem Blue Cross that provides in-network coverage to Anthem’s California customers for Sequenom’s noninvasive prenatal tests in both high- and average-risk pregnancies, effective March 1.

“Our contract with Anthem is another important step in our strategy to be an in-network provider and to bring the benefits of noninvasive prenatal testing to as many patients as possible, including women with average-risk pregnancies,” Sequenom CEO Dirk van den Boom, PhD, said in a statement.