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UK's NICE Recommends New Test for Detection of Breast Cancer Spread

NEW YORK (GenomeWeb News) – The UK's National Institute for Health and Care Excellence (NICE) has recommended a new test for use during breast cancer surgery to determine whether the cancer has spread to lymph nodes in the armpit.

In guidance published this week, NICE — which advises the UK National Health Service which tests it should make available — recommended the test called the RD-100i OSNA as an option for detecting sentinel lymph node metastases during breast surgery in people with early invasive breast cancer. Japanese healthcare company Sysmex developed and manufactures the RD-100i OSNA (short for one-step nucleic acid amplification) system.

The test, NICE said, provides results to surgeons during the initial operation, allowing them to decide whether any lymph nodes should be removed simultaneously with the initial tumor.

In turn, this could eliminate the need for a second operation and enable earlier treatment of the disease. Additionally, NICE said, the RD-100i OSNA system can analyze the whole lymph node, reducing the risk that micrometastasis will be missed.

The RD-100i OSNA system analyzes and amplifies mRNA from solubilized biopsy samples of sentinel lymph node tissue. It detects the level of expression of the cytokeratin-19 gene, which is associated with breast cancer. In healthy lymph node tissue, CK19 is not present.

Time to results is approximately 30 to 45 minutes, NICE said, and the test provides both quantitative and qualitative results.

In its recommendation document, NICE also said that a national registry should be created to collect data on the use of the RD-100i OSNA system in detecting sentinel lymph node metastases during breast cancer surgery. Patients with lymph node analysis performed on the system should also have their data submitted to the registry, and the data should be integrated with data from other registries for breast cancer.

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