Genomic Health, Inc. (Nasdaq: GHDX) today announced that Palmetto GBA, the designated national contractor for its Oncotype DX® colon cancer test, has established a formal coverage policy for all Medicare patients. The Oncotype DX colon cancer test has been clinically validated to predict risk of recurrence in patients with stage II colon cancer.
"Palmetto's coverage decision reflects the importance of evidence-based coverage and has the potential to transform care for Medicare colon cancer patients while saving the healthcare system dollars," said Kim Popovits, chief executive officer at Genomic Health. "This coverage decision allows all appropriate Medicare patients access to Oncotype DX for colon cancer and further recognizes the value our tests are delivering to physicians, payors and patients."
The policy covers men and women with stage II colon cancer. Palmetto's decision is based on the two large QUASAR and CALGB clinical validation studies in addition to clinical utility information. Coverage for the Oncotype DX colon cancer test was posted on the Palmetto GBA website on September 29, 2011 and can be referenced by clicking here. The coverage is effective for claims for services performed on or after September 18, 2011.
"The Oncotype DX colon cancer test allows physicians to go beyond the limited set of clinical and pathologic markers that they previously used in an effort to make a more precise risk assessment in the treatment planning for stage II colon cancer patients," said David Kerr, M.D., DSc, professor of cancer medicine at the University of Oxford and a principal investigator of the QUASAR validation study. "Medicare's decision will help ensure broader patient access to this important diagnostic test."
The landmark QUASAR validation study, which established a new paradigm for assessing recurrence risk in stage II colon cancer, emphasizing the critical role of the Oncotype DX Recurrence Score®, mismatch repair (MMR) status and T-stage, has been accepted for publication by the Journal of Clinical Oncology. This year Genomic Health plans to expand its Oncotype DX colon cancer offering to include immunohistochemistry (IHC) testing for MMR status to assess mismatch repair for stage II colon cancer recurrence risk.
Reimbursement for the Oncotype DX colon test was established by Palmetto using an extensive resource based analysis and an independent pharmacoeconomic analysis, and is consistent with previous decisions by other payors.
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