Regulatory Focus™ > News Articles > NICE Draft Guidance Recommends Sysmex Breast Cancer IVD

NICE Draft Guidance Recommends Sysmex Breast Cancer IVD

Posted 06 March 2013 | By Louise Zornoza

The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued draft guidance recommending reimbursement for Sysmex UK's IVD RD-100i OSNA system,  a molecular test used during surgery for determining whether breast cancer has spread to lymph nodes in patients with early invasive breast cancer who have a sentinel lymph node biopsy and in whom axillary lymph node dissection will be considered. 

The innovative new IVD is able to generate test results during surgery, eliminating the need to wait for up to two weeks for results under the current procedure and permitting immediate removal of the lymph nodes if necessary.  This avoids the need for subsequent surgery, and permits chemotherapy to begin earlier. Sysmex's diagnostic test can also analyze the whole lymph node, reducing the risk of misdiagnosis.

According to Professor Adrian Newland, Chair of the independent Diagnostics Advisory Committee, "The wait for histopathology test results can cause significant distress and anxiety for patients and can also lead to the patient having a second operation to remove more of the axillary lymph nodes if the test result is positive. This second operation can be more difficult and result in a higher risk of complications because it will involve operating on the same area of the breast and armpit as the first operation."

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

Around 11,000 people with newly diagnosed breast cancer need additional surgery to manage its spread to the lymph nodes every year. When cancer cells become detached from the main breast tumor, they can be carried in the lymph to the axillary lymph nodes located around the armpit. The first axillary lymph node to which cancer is most likely to spread from the main tumor is known as the sentinel lymph node. Sometimes, there can be more than one sentinel lymph node.

The closing date for comments on the draft guidance is March 26, 2013.

Tags: UK

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