Genomic Health – Oncotype DX Colon - 2nd confirmatory Validation Study for Stage II Colon

Results determine 3 year recurrence for stage II colon cancer.   The assay reveals the biology of the tumor (T3) indicates which are more similar to T4 Disease. The Oncotype DX colon cancer test was made available in 2010 based on results from the QUASAR study, allowing physicians to go beyond the limited set of clinical and pathologic markers to make more informed decisions about the adjuvant use of chemotherapy for stage II colon cancer based on the quantitative individualized assessment of recurrence risk," said Steven Shak, M.D., chief medical officer at Genomic Health. "These results, together with the positive confirmatory clinical study presented by the CALGB at ASCO in June and Medicare's recent coverage announcement pave the way for expanded reimbursement and increased patient access to the Oncotype DX colon cancer test."

The QUASAR clinical validation study analyzed 1,436 patients with stage II colon cancer. http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=621739.

Genomic Health launched an Oncotype DX DCIS Test in January 2012.

This is a multigene assay that can accurately quantify a woman’s risk of recurrence prior to radiation therapy. The assay was validated on patients from ECOG 5194 Study.

The study, presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score goes beyond traditional clinical and pathologic measures to predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.

Understanding the biological risk will better determine the risk and help patients and clinician’s weight the treatment options. http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=630902.

Click Here for the HCP Announcement Letter

Click Here for the Velcade Prescribing Information

Amgen is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) have established a product-specific Healthcare Common Procedures Coding System (HCPCS) J-code, or permanent code, for Prolia^® (denosumab) and XGEVA^® (denosumab).  Effective for dates of service on or after January 1, 2012, the new J-code for both Prolia^® and XGEVA^® is J0897. 

The new J-code, J0897 for Prolia^® and for XGEVA^®, should be used instead of the current miscellaneous J-code (J3590) as well as the current C-code (C9272) when processing claims forms with dates of service on or after January 1, 2012.

The new J0897 code is included in the 2012 version of coding manuals that providers rely on for coding information. We encourage that this new code be implemented within the first 90 days of the calendar year, to allow for a smooth transition in processing physician claims.

Effective January 1, 2012 JEVTANA® has been assigned a HCPCS J-Code:
J9043 Injection, cabazitaxel, 1 mg
by CMS (Centers for Medicare and Medicaid Services).
Click here information for JEVTANA® using the CMS 1500.

REDWOOD CITY, Calif., Sept. 30, 2011 /PRNewswire/ -- 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.

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is fully available through established distribution channel [Read full news release]

Full ABRAXANE® info here: ABRAXANE