Clinical OMICS

MAR-APR 2019

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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4 Clinical OMICs March/April 2019 News GenomeDx to Pay $1.99M to Settle Medicare Billing Allegations GenomeDx Biosciences has agreed to pay the U.S. federal government $1.99 million to settle allegations that it submitted false claims to Medicare for the Decipher post-opera- tive genetic test for prostate cancer patients. The federal government alleged that GenomeDx violated the False Claims Act by knowingly submitting claims for the Decipher test to Medicare between September 2015 and June 2017 that were not medically reasonable and necessary. Authorities reached that conclusion after determining that the prostate cancer patients did not have risk factors necessitating the test, including pathological stage T2 disease with a positive surgical margin, pathological stage T3 disease, or rising Prostate-Specific Antigen (PSA) levels after an initial PSA nadir, the U.S. Department of Justice said. The Decipher test is designed to predict the probability of metastasis after surgery, as well as provide an independent assessment of tumor aggressiveness that differs from information provided by Gleason score or PSA. n The Broad Gets $25M for New Cancer Diagnostics Center To address what it considers a lag in the development of diagnostics for more pre- cise cancer monitoring, the Broad Insti- tute of MIT and Harvard announced it will open the Gertsner Center for Cancer Diag- nostics, funded by a $15 million commit- ment by Louis V. Gertsner, Jr., the former CEO and chairman of the board of IBM. The new research center will focus on blood-based biopsies that can be used to track disease progression and other cancer diagnostic methods and technol- ogies. The initial focus on blood-based biopsies to develop diagnostics follows a fast-growing trend in the field for these tests to monitor disease progression and therapeutic efficacy. Advanced liquid biopsy tests for cancer monitoring have the advantage of eliminating the need for invasive solid tissue biopsies or, when a tissue biopsy is not possible, expensive imaging tests such as CT or MRI. n FDA Grants Priority Review for Keytruda in SCLC The U.S. Food and Drug Administration (FDA) announced that it has granted priority review status for Merck's anti-PD-1 drug Keytruda (pembrolizumab) for the treatment of small cell lung cancer (SCLC) as a monotherapy for patients whose disease has not responded to two or more lines of prior therapy. "There is a significant need for new treatment options for small cell lung cancer, which has a five-year survival rate of only six percent overall," said Jonathan Cheng, vice president, oncology clinical re- search, Merck Research Laboratories, in a press release. "Keytruda has already been established as an important treatment option for many patients with advanced non-small cell lung cancer and this acceptance provides an opportunity to potentially benefit even more patients." Under the new supplemental Biologics License Application (sBLA) for the drug, Merck is seeking accelerated approval for this indication based on data from two of its ongoing clinical studies: the Phase II KEYNOTE-158 and Phase Ib KEYNOTE-028. The FDA has set a targeted action date of June 17, 2019. It is Merck's first application for the use of Keytruda in SCLC. n SCIEPRO / Science Photo Library/ Getty Images William_Potter / iStock / Getty Images

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