CEO SUMMARY: Since 2011, the University of Florida Health System has used pharmacogenetic test (PGx) results to guide physicians when they prescribe certain drugs. This initiative has improved patient outcomes, reduced the overall cost per episode of care, and gained partial reimbursement from health insurers for PGx test claims. As this testing becomes more widespread, clinical
INVITAE, A GENETIC TESTING COMPANY IN San Francisco, has begun a retest program involving 50,000 patients. Such a large retest effort is without precedent in the still-nascent genetic testing marketplace.
Clinical laboratories and genetic testing companies commonly find that, in daily operations, a batch of samples produced unreliable or inaccurate results. These discoveries are made as
CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers and Medicare to reimburse for pharmacogenomic tests, Avera Institute for Human Genetics (AIHG) in
CEO SUMMARY: Across the lab industry, next generation sequencing is taking hold as an effective and efficient testing platform. In response, payers are developing coding and payment policies that may affect the finances of clinical labs. Last month, Palmetto GBA, a Medicare contractor, issued NGS test guidelines that some experts see as an attempt to
CEO SUMMARY: Clinical laboratories of all sizes are poised to become the source of much of a hospital or health system’s “big data.” At many academic center labs, greater use of genetic and molecular testing requires that more space and more staff be devoted to data management. At the same time, the latest generation of gene sequencing instruments and molecular analyzers are cheaper, faster, and more automated. These systems make it feasible for even smaller labs to offer sophisticated genetic tests.
CEO SUMMARY: Probably the most challenging infections for hospitals to control and reduce are methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile (C. diff). The laboratory at one New York hospital introduced algorithms to screen for the presence of each infection. In the past five years, the hospital not only cut costs by almost $3 million
In response to the Ebola outbreak, the Food and Drug Administration issued an emergency authorization for the use of two rapid tests to detect Ebola. The tests are manufactured by BioFire Defense LLC, a division of BioMerieux. The BioFire Defense FilmArray NGDS BT-E Assay is authorized for use by laboratories designated by the Department of
bioMérieux is on the move. Last week it announced that it would pay $450 million to purchase privately-held BioFire Diagnostics of Salt Lake City, Utah. BioFire has a solid tech- nology base in molecular diagnostics. It developed and currently markets its FilmArray product, which it describes as a multiplex PCR system. BioFire also designed the LightCycler
CEO SUMMARY: Motivated by the goal of delivering more value to clinicians and client hospitals, the lab team at TriCore Reference Laboratories in Albuquerque, New Mexico, is proactively introducing new services. One such initiative is to travel to hospitals to participate in rounds and consult with physicians regularly. Another initiative improved the accuracy of C.
CEO SUMMARY: In Brampton and Etobicoke, Ontario, the hospital laboratories of William Osler Health System are using the quality management system of ISO 15189 to stay ahead of two powerful trends. Combining the QMS with Lean methods allows the labs’ management and staff to continuously improve performance in four important dimensions: decreasing turnaround times, reducing