20151009 - Oct 9, 2015
ISSUE 37 – OCT. 9, 2015PDF

CT Colonography and Stool DNA

Fail to Make USPSTF A-List



CT colonography and stool DNA failed to get on the list of preferred tools for screening for colorectal cancer.

A draft guideline from the U.S. Preventive Services Task Force released Oct. 6 calls for using one of three strategies:

• Fecal immunochemical test or high-sensitivity guaiac-based fecal occult blood test every year;

• Flexible sigmoidoscopy every ten years, plus FIT every year; or

• Colonoscopy every ten years.

Capitol Hill

Collins to Congress: A Flat, Year-long CR Would Be “Devastating” to NIH Research

If Congress passes another year-long, flat-funding resolution, the effect on NIH “would be simply devastating,” Director Francis Collins told a Senate appropriations subcommittee during a hearing Oct. 7.

“I can’t emphasize enough how much we are worried about this,” Collins said, sitting alongside NCI Acting Director Douglas Lowy and other institute directors.

    CMS Issues Updated Pricing For Clinical Lab Fee Schedule

    Centers for Medicare and Medicaid Services issued updated pricing determinations for the Clinical Laboratory Fee Schedule, which reversed a payment cut for the Oncotype DX breast cancer test.

      Letter to the Editor from the Coalition for 21st Century Medicine

      Dear Editor,

      We are writing to clarify a few points in your Oct. 2 article, “CMS to Trim Spending on Diagnostic Lab Tests,” as it mistakenly intertwines two issues.

        In Brief

        • Tomas Lindahl, Paul Modrich, and Aziz Sancar win the Nobel Prize

        • Alexander Eggermont’s directorship of Institut Gustave Roussy extended by 5 years

        • Victoria Seewaldt joins City of Hope

        • NYU Langone names Shohei Koide to lead new biologics research program

        • Memorial Sloan Kettering and Cornell University to launch nanomedicine center

        • Oncology Nursing Society launches clinical resource platform

        • SWOG to fund Veterans Affairs Department medical centers

        Drugs and Targets

        • FDA grants breakthrough therapy designation to abemaciclib in breast cancer

        • Merck and Bionomics Ltd. extend collaboration

        • Immunovia and OHSU form pancreatic cancer collaboration

        • MD Anderson and Theraclone Sciences launch OncoResponse company

        20151002 - Oct 2, 2015
        ISSUE 36 – OCT. 2, 2015PDF

        CMS to Trim Spending on Diagnostic Lab Tests

        The Centers for Medicare and Medicaid Services appear to be executing a two-step strategy to shrink the $8 billion annual price tag of clinical diagnostic laboratory tests.

        On Sept. 25, CMS released a final payment determination for the Clinical Laboratory Fee Schedule that cuts payment by over 90 percent for some tests.

        One of the industry leaders, Genomic Health, saw payments for Oncotype DX breast cancer tests drop by 15 percent, and a 79 percent drop for its colon cancer test. The determination involves a set of nine codes for advanced diagnostic laboratory tests.

        Guest Editorial

        Local Medicare Contractors Bring Chaos to CMS Coverage of Next Generation Tests

        By Dane Dickson

        Yesterday, two Medicare administrative contractors—National Government Services and Cahaba Government Benefit Administrators—released draft local coverage determinations for next generation sequencing in advanced lung cancer.

        The NGS LCD covers the initial diagnosis of lung cancer and Cahaba’s LCD covers patients who have been re-biopsied to test for additional mutations that may have been missed on testing of the initial biopsy by older technology.

          BMS Combination Approved in Melanoma;

          Dana-Farber Challenges BMS Patent Rights

          A combination of two Bristol-Myers Squibb immuno-oncology agents—Opdivo (nivolumab) and Yervoy (ipilimumab)—received an accelerated approval for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

          The Oct. 1 announcement marks the first time FDA has approved a combination regimen of two immuno-oncology agents in cancer—both drugs had previously been approved as monotherapies for the same indication.

            Capitol Hill

            Congress Averts Shutdown, Funds NIH Through December

            Congress passed a continuing resolution Sept. 30—averting a shutdown—that will fund the federal government at current levels through Dec. 11.

            Funding for both NIH and NCI dipped slightly as part of a 0.21 percent cut to all non-defense discretionary agencies.

              USPSTF Speaks on its Role In the Affordable Care Act

              The U.S. Preventive Services Task Force published a viewpoint in the Journal of the American Medical Association to clarify how their recommendations are linked to the Affordable Care Act coverage mandate—and how they believe clinicians, payers, and the public should interpret their recommendations.

              The viewpoint, titled “Evidence-Based Clinical Prevention in the Era of the Patient Protection and Affordable Care Act: The Role of the US Preventive Services Task Force,” describes how some have misinterpreted task force grades of C or I as recommendations against screening or even against coverage.

                Funding Opportunity

                Pershing Square Sohn Cancer Research Alliance Prize For Young Investigators

                The Pershing Square Sohn Cancer Research Alliance is taking applications for its Prize for Young Investigators in Cancer Research.

                  In Brief

                  • Richard O’Reilly to step down as chair of pediatrics at MSKCC

                  • James Wade named deputy director at Inova cancer institute

                  • MSKCC’s Lorenz Studer named MacArthur Fellow

                  • Three investigators named winners of the Paul Marks Prize

                  • Kesari joins Providence Saint John’s Health Center

                  • Turaga named endowed professor in sarcoma research at Medical College of Wisconsin

                  • Jan Schluchter named CCO at Myriad Genetics GmbH

                  • Stand Up to Cancer Canada Dream Team members announced

                  • Center to Advance Palliative Care publishes state-by-state report card
                  Drugs and Targets

                  • FDA grants accelerated approval to Keytruda in NSCLC

                  • EMA CHMP grants two positive opinions to Kyprolis and Blincyto

                  • FDA grants priority review to defibrotide for hepatic VOD

                  • Aspen Park acquires Ohio State’s APP-111

                  • UbiVac and Janssen form collaboration

                  • City of Hope and Sorrento Therapeutics form LA Cell Inc.

                  20150925 - Sep 25, 2015
                  ISSUE 35 – SEPT. 25, 2015PDF

                  Information Blocking by E-Health Record Firms Threatens CancerLinQ, ASCO Says 

                  Congress must put an end to the emerging practice of “information blocking” by demanding that electronic health records are able to exchange data in an “interoperable” fashion, the American Society of Clinical Oncology urged at a congressional briefing.

                  At the briefing Sept. 15, ASCO said that some EHR companies are erecting obstacles that preclude the sharing of data contained in patient health records.

                  Baselga: Why I Believe NIH is On Threshold of the Largest Budget Increase in 12 Years

                  As congressional leaders discuss potential ways to avert a government shutdown, which could happen in less than a week if policymakers are unable to agree to a short-term continuing resolution to keep the government running beyond Sept. 30, I remain optimistic that NIH will receive its largest annual budget increase in 12 years.

                  After 12 years of flat funding, a significant number of members of Congress on both sides of the aisle are enthusiastically backing the NIH, which is the largest supporter of medical research in the world. Many in Congress, Republicans and Democrats alike, appear to be singing from the same song sheet about the importance of prioritizing the NIH budget.

                    In Brief

                    • UNC, Vanderbilt get “exceptional” scores for Cancer Center Support Grant renewal applications

                    • Peter Schultz named CEO, Steve Kay named president of The Scripps Research Institute

                    • Jeffrey Medin named MACC Fund Endowed Professor at the Medical College of Wisconsin 

                    • Evelyn Whitlock named chief science officer at Patient-Centered Outcomes Research Institute

                    • Joaquin Espinoza named associate director of science at the Linda Crnic Institute for Down Syndrome
                    • Robert Schreiber, Philip Greenberg named editors-in-chief of Cancer Immunology Research
                    • Christoph Zielinski named editor-in-chief of ESMO Open
                    • Huntsman Cancer Institute becomes first Mediso Preclinical Imaging Center of Excellence in North America
                    • SCIEX announces collaboration with Fred Hutchinson on targeted proteomics
                    • Experimental Therapeutics at Mount Sinai team up with Regeneron on antibody research
                    • Thomas Jefferson and GenomOncology co-developing cancer profiling system
                    • Gilda’s Club Chicago, cancer organizations launch metastatic breast cancer awareness campaign
                    • The Ride to Conquer Cancer raises $2.1 million for cancer research
                    Drugs and Targets

                    • FDA approves Varubi for chemotherapy-induced nausea

                    • Roche NimbleGen introduces enhanced whole exome sequencing solution for medical and translational research

                    • CTI BioPharma Corp. plans to submit NDA for pacritinib

                    • Amgen Inc. and Xencor Inc. enters immunotherapy research agreement