Regulatory Focus™ > News Articles > NICE Guidance Recommends New Test for Breast Cancer Metastasis

NICE Guidance Recommends New Test for Breast Cancer Metastasis

Posted 08 August 2013 | By Louise Zornoza

The UK's National Institute for Health and Care Excellence (NICE) has issued guidance recommending a new test for surgeons to use to determine whether breast cancer has spread. The test, the RD-100i OSNA system produced by Sysmex UK, can detect if the cancer has spread to lymph nodes in the armpit during the surgery to remove the tumor.

This is a significant advance over the current practice, in which the sentinel lymph nodes are removed during the initial tumor removal surgery, and biopsied to determine whether the breast cancer has spread. The results from the biopsy can then take up to 15 working days and if positive, the patient has to have a second operation to remove the remaining lymph nodes. The new test can also analyze the whole lymph node and therefore may reduce the risk of a micrometastasis being missed.

Approximately 11,000 people with newly-diagnosed breast cancer need further surgery to manage the spread of the disease to the lymph nodes every year.

"The Committee heard from a patient expert that the option of not having to have a second operation was an important consideration for patients," NICE Technology Evaluation Centre Director Professor Carole Longson said in a statement. "The Committee also considered that the accuracy of histopathology may vary depending on the number and size of the lymph node sections examined."

"The Committee therefore concluded that analysis of sentinel lymph nodes using the RD-100i OSNA system during operations had considerable advantages over traditional histopathology testing and had the potential to reduce both clinical complications, and patient anxiety and distress," Longson concluded.

NICE Guidance on RD-100i

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Tags: Breast Cancer, UK, EU

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