Clinical OMICS

JAN-FEB 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com January/February 2017 Clinical OMICs 7 News Interpace Diagnostics Drives Payment Strategy via BCBS Association's Evidence Street Interpace Diagnostics has joined the Blue Cross Blue Shield (BCBS) Associa- tion's Center for Clinical Effectiveness "Evidence Street" program, enabling the cancer-focused molecular diagnostics developer to present evidence designed to support future coverage decisions for all its marketed tests. Interpace will work with Evidence Street to develop methods allowing the company to secure and preserve ongo- ing coverage for a range of its marketed molecular diagnostics for thyroid cancer and pancreatic cancer, as well as pipeline tests such as BarreGen, designed to pre- dict risk of progression from Barrett's esophagus to esophageal cancer. All Interpace marketed products are covered regionally by Medicare and numerous commercial plans, as well as some BCBS plans. BCBS says the two criteria it most heavily weighs as it evaluates new technologies are clinical utility and patient outcomes. "We have already demonstrated both clinical utility and patient outcomes suf- ficient to gain BCBS coverage in several markets," Interpace president and CEO Jack E. Stover told Clinical OMICs. One market Interpace hopes to crack is the Phoenix area, which it considers one of its largest opportunities, but where BCBS of Arizona does not cover the company's tests. Interpace won't disclose which BCBS plans cover its tests, since most of its contracts have confidentiality clauses. "The Evidence Street program will assist us in enhancing our plans, not only with other BCBS regional plans, but with other private insurers as well and with our current products and our near-term products," Stover added. "The goal is to establish a more robust and convincing process and data presentation to facilitate broader acceptance of these valuable assays." Interpace cites favorable clinical-utility conclusions from multiple studies of tests in its endocrine franchise, consisting of ThyGenX and ThyraMIR, and its gastrointestinal franchise, which includes PancraGEN for pancreatic cancer. ThyGenX uses next-generation sequencing to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas. Thy- raMIR, the first microRNA gene expression classifier, measures the expression of 10 microRNAs. PancraGEN is a pancreatic cyst molecular test designed to aid in pancreatic cancer risk assessment by using a small sample of pancreatic cyst fluid.—Alex Philippidis It requires only small fragments of DNA (approximately 1 ng) to deliver long- range sequence information, perform haplotype phasing, and reveal structural genomic variation, in addition to other genomic content. "This relationship with 10x Genomics will enhance the PerkinElmer automa- tion menu and help progress research- ers' interpretation of some of the most important biological questions through increased sequence information and insights into the complexity of the genome," says Prahlad Singh, senior vp and president of diagnostics, PerkinElmer. Affimed, MD Anderson Ink Immuno-Oncology Development Deal G er man clinical-stage biophar ma company Affimed and MD Anderson announced a development and commer- cialization agreement in immuno-oncol- ogy that will evaluate Affimed's bispecific antibodies in combination with the nat- ural killer (NK) cell technology of MD Anderson. Affimed calls its bispecific antibodies "TandAbs" due to their tandem antibody structure, which is designed to direct and establish a bridge between either NK cells or T cells and cancer cells. TandAbs can (continued on next page) NIAID / Creative Commons Minerva Studio / Getty Images Colorized scanning electron micrograph of a natural killer cell from a human donor.

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