IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible
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Personalized medicine or PM is a medical model that proposes the customization of healthcare, with medical decisions, practices, and/or products being tailored to the individual patient. In this model, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient’s genetic content or other molecular or cellular analysis.
The use of genetic information has played a major role in certain aspects of PM. and the term was first coined in the context of genetics, though it has since broadened to encompass all sorts of personalization measures.
Personalized medicine is not limited to pharmaceutical therapy. Advances in computational power and medical imaging are paving the way for personalized medical treatments that consider a patient’s genetic, anatomical and physiological characteristics.
Several terms, including “precision medicine,” “targeted medicine” and “pharmacogenomics” are sometimes used interchangeably with “personalized medicine.”
According to the FDA, the term is often described as providing ‘the right patient with the right drug at the right dose at the right time.’ More broadly, PM may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.
Advances in genetic and molecular knowledge about different diseases are widely expected to generate more opportunities for PM products and services. Clinical laboratories and pathology groups are continually developing new capabilities in molecular diagnostics, such as the analysis of DNA, RNA, and the human proteome.
Reimbursement policies will have to be redefined to fit the changes that PM will bring to the healthcare system. Some of the factors that will be considered are the level of efficacy of various genetic tests in the general population, cost-effectiveness relative to benefits, how to deal with payment systems for extremely rare conditions, and how to redefine the insurance concept of “shared risk” to incorporate the effect of the newer concept of “individual risk factors.”
CEO SUMMARY: With each passing year, the primary role of hospital and health system labs evolves in a different direction than that of independent lab companies. This trend is a response to the creation of integrated delivery networks paid on value and how they are scored on their ability to keep patients out of hospitals
HEALTHCARE BIG DATA IS ADVANCING in California and all pathologists in the Golden State will be required to submit data to the state’s cancer registry beginning in 2019.
California’s new law to support the state’s cancer registry is the latest example of an effort to ensure the timely collection of complete sets of data needed to
This is an excerpt from a 2,026-word article in the July 17, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: It’s the second time in six years that a Japanese corporation
CEO SUMMARY: It’s the second time in six years that a Japanese corporation paid a high price for a genetic testing company in the United States. Konica Minolta will purchase Ambry Genetics for $800 million at closing and $200 million upon hitting certain financial metrics. In 2011, Miraca Holdings acquired Caris Life Sciences for $725
CEO SUMMARY: At the University of Michigan Medical Center, the Department of Pathology is learning new ways to add value that include face-to-face meetings with patients as part of UMMC’s patient- and family-centered care initiative. One lesson learned is that patients appreciate the opportunity to get a better understanding of the results from both anatomic
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
This is an excerpt from a 2,700-word article in the January 30 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: One essential element of precision medicine — the wave of the future in
CEO SUMMARY: Among the three chief reasons for the merger of CellNetix and Puget Sound Institute of Pathology, the most compelling was the need to address the challenges in the current reimbursement environment and to prepare for reductions in payment to pathologists expected in the coming years under the Patient Access to Medicare Act. CellNetix
CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utility of their assays. Among them is Foundation Medicine, of Cambridge, Mass. In