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Tag Archives: Put It on the Board —

Put It on the Board, 11/15

November 2015—Approvals mark ‘tip of the iceberg’ for PD-L1 testing: What the FDA giveth, the FDA may taketh away. On Oct. 2, the agency approved the use of Merck’s immunotherapy drug Keytruda (pembrolizumab) to treat patients with metastatic non-small cell lung cancer whose disease has progressed after chemotherapy and whose tumors express the PD-L1 protein. Dako’s IHC 22C3 pharmDx test kit was approved as a companion diagnostic for use with the drug.

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Put It on the Board, 10/15

Neuropathologist Dr. Omalu in spotlight at CAP ’15: Bennet Omalu, MD, MBA, MPH, who gave the spotlight event speech at CAP ’15 earlier this month, says he met retired Pittsburgh Steeler Mike Webster before conducting the 2002 autopsy that would lead to the first diagnosis of chronic traumatic encephalopathy in a National Football League player.

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Put It on the Board, 9/15

September 2015—Roche buys ‘sample in, susceptibility out’ technology: Roche has signed a definitive agreement to acquire Los Gatos, Calif.-based GeneWeave BioSciences, a privately held company focused on molecular clinical microbiology diagnostic solutions. The acquisition provides Roche with GeneWeave’s Smarticles technology, which quickly identifies multidrug-resistant organisms and assesses antimicrobial susceptibility directly from clinical samples without the need for traditional enrichment, culture, or sample preparation processes.

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Put It on the Board, 8/15

August 2015—To meet TAT goals, Vanderbilt builds ED lab: In a move expected to help meet accreditation standards on testing turnaround times for stroke and chest pain patients, Vanderbilt University Medical Center’s emergency department will gets its own satellite laboratory this month.

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Put it on the Board

July 2015—Amid excitement about the groundbreaking work of unlocking the human genome’s secrets to speed diagnosis and target oncologic treatment comes the unpleasant reality that much of this labor now goes unpaid. Getting the American Medical Association’s editorial panel to publish nearly two dozen new genomics-related CPT codes for molecular pathology was a vital step, as was having those codes accepted in the Medicare clinical laboratory fee schedule.

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Put It on the Board, 4/15

April 2015—Door opens on direct access to genetic tests: The FDA’s recent move to give 23and­Me permission to market this country’s first direct-to-consumer genetic test, for Bloom syndrome, goes beyond the one in 107 Jews of Ashkenazi descent who are carriers of the rare disorder.

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Put It on the Board, 3/15

AMP outlines laboratory view on incidental findings: The American College of Medical Genetics and Genomics’ controversial 2013 recommendations on the reporting of incidental findings on select genes was the first attempt to address the matter in the clinical setting. But the ACMG’s recommendations pose significant challenges that labs undertaking next-generation sequencing must be prepared to address, said a special report written by an Association for Molecular Pathology working group.

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Put It on the Board

February 2015—Two medical organizations said that using an HPV test alone for cervical cancer screening is an effective alternative to the current recommendation for screening with either cytology alone or cotesting with cytology and HPV testing. Pathology leaders said the multispecialty-developed guidance leaves the Pap test standing as a first-line screening option.

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