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In response to comment letters submitted by PMC and a slew of other stakeholders, the Centers for Medicare & Medicaid Services (CMS) has agreed to extend the timeline for implementing market-based pricing and has altered its definitions of an "applicable laboratory" and an "advanced diagnostic laboratory test" (ADLT). In its most recent statement on the topic, American Clinical Laboratory Association (ACLA) President Alan Mertz indicates that PAMA's market-based methodology is a step forward for the industry.
» PMC comment letter
» GenomeWeb (subscription content)
Biden Launches Data-Sharing Platform as Part of 'Moonshot' Effort
Joe Biden's "Moonshot" Task Force recently launched the Genomic Data Commons (GDC) database, which allows cancer researchers from anywhere in the world to upload data. It is Joe Biden and the National Cancer Institute's hope that it will become a rich resource for researchers who want to find associations pertinent to cancer treatment.
FDA Approves cobas EGFR Mutation Test v2 as First Liquid Biopsy Companion Diagnostic
The FDA has, for the first time, approved a liquid biopsy test as a companion diagnostic, accepting Roche Molecular Diagnostics' cobas EGFR Mutation Test v2 as a safe and effective tool for identifying non-small cell lung cancer (NSCLC) patients eligible for treatment with Tarceva (erlotinib).
» FDA statement
A new partnership between Thermo Fisher Scientific and West China Hospital of Sichuan University may point to a future in which pharmaceutical and diagnostic companies regularly work with health care providers on personalized medicine initiatives, says PMC President Edward Abrahams. The institutions will build centers to train pathologists and implement standardized quality control, all with an eye toward a jointly developed, high-impact research platform.
» CenterWatch Weekly
Intermountain, Stanford, Providence to Share Data in Context of 'Moonshot' Task Force
In an unprecedented collaboration, Intermountain Healthcare, the Stanford Cancer Institute and Providence Health & Services have joined forces with Syapse to share genomic and other data. Through the partnership, called the Oncology Precision Network (OPeN), the organizations hope to offer better care to their patients and increase access to clinical trials.
» Syapse press release
Boehringer Ingelheim to Investigate Olmutinib as Option for Patients With Resistance to Other EGFR Inhibitors
Boehringer Ingelheim has announced an effort to study the safety and efficacy of ELUXA (olmutinib), as a treatment option for non-small cell lung cancer (NSCLC) patients. The trials build on earlier data suggesting that ELUXA can improve outcomes for patients who have become resistant to first-line TKI therapies.
» Boehringer Ingelheim press release