Medical Device Network

UK NICE backs Exact’s Oncotype cancer genomic test

The UK agency has recommended expanded use of Exact’s Oncotype DX test to help physicians make chemotherapy decisions for breast cancer patients.

The UK’s National Institute for Health and Care Excellence (Nice) has recommended the use of Exact Sciences’s genomic test Oncotype DX breast recurrence score test to help physicians manage chemotherapy care for patients with breast cancer.

The UK agency recommends the use of the breast recurrence score test to identify postmenopausal individuals with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), and early-stage breast cancer involving up to three positive nodes.

The latest recommendation adds to previous NICE guidance to use the test in HR+ HER2- early-stage breast cancer patients without lymph node involvement.

“There is an urgent need to target chemotherapy more precisely to those most likely to benefit from it so that patients can avoid unnecessary side effects,” said Dr Caroline Archer, consultant medical oncologist at Portsmouth Hospital National Health Services (NHS) Trust.

“The Oncotype DX Breast Recurrence Score result enables us to do this effectively by providing specific information about an individual’s response to chemotherapy.”

Chemotherapy is usually a first-line treatment for cancers including breast cancer. As newer alternative therapies are now available for cancer treatment, genomic testing can save patients both time and unwanted side effects by determining whether the chemotherapy will be effective for the patients.

The recommendation was based on the data from the data from TAILORx (NCT00310180) and RxPONDER (NCT01272037) trials showing the Oncotype DX assay’s efficacy in determining the efficacy of chemotherapy in patients with either node-negative or node-positive early-stage breast cancer. The Oncotype DX has 85% sensitivity in identifying postmenopausal patients whose cancer outcomes are not likely improved by chemotherapy.

The Oncotype DX breast recurrence score test is part of Exact’s precision oncology portfolio, which consists of other genomic tests such as OncoExTra, a tumour profile test, and the Oncotype DX colon recurrence score test. The precision oncology portfolio generated $163m in sales in Q1, according to Exact’s financials.