At first glance, it’s hard to imagine anything as obscure as a policy by a private contracting firm that runs the Medicare program in the Carolinas, Virginia and West Virginia.
But look closer: a “local coverage determination” by Palmetto GBA addresses an urgent, vexing problem of precision oncology: how advanced molecular testing can be used to determine treatment options for individual patients and what insurers will be willing to pay for.
The coverage determination, titled “Comprehensive Genomic Profiling for Non-Small Cell Lung Cancer” popped up on a government website well after close of business Jan. 22. There was no press release; no rollout whatsoever.
Nonetheless, the decision may introduce clarity into the informational pea-soup fog that engulfs molecular testing by spelling out the criteria for opening payment for complex tests and comprehensive genomic assays, which measure multiple markers.
As it stands, the vast majority of assays that cost thousands of dollars and are used to determine treatment for cancer patients are not reviewed by government agencies before they enter the marketplace.
Attorneys defending Duke University are preparing to argue that no patients were harmed in the institution’s phase II clinical trials of genomic predictors that were later shown fraudulent.
The technology in question came from the laboratories of Duke stars Joseph Nevins and Anil Potti, and was based on findings that, from the outset, seemed too good to be true—and were ultimately discredited and retracted.
The suit claims negligence, breach of fiduciary duty, unjust enrichment, infliction of emotional distress, loss of chance, battery, deceptive trade practices, civil conspiracy and obstruction of justice.
The trial is scheduled to begin Jan. 26 at Durham County Superior Court. Altogether, 117 patients enrolled in the three clinical studies at Duke.
The essence of Duke’s argument—which forms the basis of a flurry of motions for a partial summary judgment—is that patients who entered the clinical studies were, for the most part, in late stages of disease and that the predictor models were used to assign them to existing therapies.
 | News Analysis
Misconduct Expert Dissects Duke Scandal By C. K. Gunsalus On Jan. 9, 2015, The Cancer Letter reported that Duke University received information in early 2008 that called into question the validity of the methodology and results published by the Anil Potti research group. Potti, along with his mentor and co-author Joseph Nevins, had galvanized the world of cancer research in 2006 and 2007 with their reports of successful gene expression tests for directing cancer therapy, the “holy grail” of cancer research. The 2008 information came in the form of a letter from a third-year medical student, Brad Perez, who was working in Potti’s lab. The letter, which does not seem to have been given any credence at the time, described with precision the problems that eventually resulted in the termination of clinical trials and the subsequent retractions, beginning in 2011, of at least ten (and counting) papers from major scientific journals. |
 | Cancer Drug Prices Increased $8,500 Per Year Since 1995 The launch prices of anticancer drugs have increased substantially over time—even when adjusted for inflation and survival benefits—according to a study published by the National Bureau of Economic Research. |
 | State of the Union 2015
Obama Launches Precision Medicine Initiative President Barack Obama called for innovation in genetic medicine, through the launch of a new initiative, in his State of the Union address Jan. 20. “Twenty-first century businesses will rely on American science and technology; research and development,” Obama said. “I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable,” he said. “So tonight, I’m launching a new precision medicine initiative, to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthy.” |
 | ASCO Teams with SAP For CancerLinQ Project The American Society of Clinical Oncology announced Jan. 21 that its CancerLinQ health information technology project will use the SAP HANA platform. SAP HANA is a flexible, in-memory data management and application platform that provides predictive text analytics, spatial processing and data virtualization. SAP has teamed with medical organizations in Germany and Japan for cancer data analytics and genomic analysis. |
 | Letter to the Editor
Is $100M in Stock Enough to Make MD Anderson Go Public with its Conflict-of-Interest Management Plan? By Leonard Zwelling Last week, it was reported in both The Cancer Letter and the Houston Chronicle that The University of Texas MD Anderson Cancer Center had closed a deal to sublicense intellectual property to two pharmaceutical firms, Intrexon and Ziopharm Oncology. There is nothing terribly unusual about that. The deals, however, were mostly in exchange for equity, $50 million in stock from each company plus $15-20 million per annum. The technology is chimeric antigen receptor T cells (CAR T) and The Cancer Letter article suggests that the clinical trials testing the technology’s efficacy will be done at MD Anderson, at least in part. This struck me as odd. |
 | Letter to the Editor
LLS President Responds To “Bad Luck” Cancer Study By Louis J. DeGennaro A new study indicates that the risk of developing cancer in some types of tissue is based on the frequency of stem cell divisions, and therefore beyond individuals’ control to minimize their own risks. As the study stated, a majority of these cancers develop due to random mutations of noncancerous stem cells; in other words, it’s just “bad luck.” |
 | In Brief
Moffitt’s Johnathan Lancaster to join Myriad Genetics Sue Biggins receives prize from Genetics Society of America Pancreatic Cancer Action Network and NCI’s Frederick National Lab award two fellowships Caris Life Sciences establishes Caris Centers of Excellence for Precision Medicine Network City of Hope and Trovagene Inc. enter into clinical collaboration WuXi PharmaTech acquires NextCODE Health Medical University of South Carolina location upgrades imaging systems Royal Phillips partners with Indica Labs Inc. Picador acquires world publishing rights to the debut novel by Paul Goldberg, editor and publisher of The Cancer Letter
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 | Drugs and Targets
European Medicines Agency’s CHMP issues positive opinion on Jakavi for Polycythemia Vera Palmetto GBA publishes CMS coverage policy for Decipher prostate cancer classifier Ventana Medical Systems submits ALK assay for FDA premarket approval
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