Tag: companion diagnostic test

PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to certain medications. Some pathologists and lab executives have criticized the FDA’s actions

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Why Pharma, Private Equity Want to Reshape Lab Industry

CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access

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Detroit Hospital Develops 10 Ways To Add More Value

Cost Avoidance Example

CEO SUMMARY: Clinical labs are beginning to make the transition from a volume-based financial model to a model based on value-based payments. To survive this transition, labs must find ways to create value. The lab at Henry Ford Health System has identified 10 ways that it can contribute more value to physicians and its parent health system. One way is to help eliminate needless tests and processes. Other initiatives involve improving supplier processes, helping to reduce patient length of stay, creating a lab test formulary, and demonstrating the financial efficacy of all lab interventio

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Pathologists Can Offer ‘Companion Informatics’

CEO SUMMARY: Community hospitals are recognizing increased interest in personalized medicine among consumers. One expert predicts that this will create opportunities for hospital labs and pathology groups to add value by offering subspecialty expertise in molecular diagnostics, genetic testing, and “companion informatics.” At the University of Louisville School of Medicine, the Department of Pathology and

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“Primary-Care Pathology” One Goal at Beth Israel

CEO SUMMARY: In a pioneering collaboration, the pathology department at Beth Israel Deaconess Medical Center in Boston, Massachusetts, will work with GenomeQuest, Inc., to perform whole genome sequencing of tumor specimens. GenomeQuest will handle sequencing, assembly, and annotation of the genetic data. BIDMC will analyze these whole human genome sequences to develop companion diagnostic tests

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