In June 2022, Mithuruwela the Cancer Support Network moved away from its customary activities which included awareness- raising and caregiver support, a news release from the organzation said.

“Inspired by an appeal from Dr Nuradh Joseph, Oncologist, the organization helped to support the establishment of molecular testing at the Anuradhapura Teaching Hospital. This initiative marks the first time molecular testing for breast cancer has been instituted in a state hospital and Mithuruwela is proud to be part of this endeavor,” it said.

Breast Cancer and Molecular Testing Of all the cancers affecting females in Sri Lanka, Breast Cancer is the commonest. Records of cancer in the island are maintained annually and according to data from the National Cancer Registry nearly 4,000 new cases are diagnosed each year.

The diagnosis of breast cancer is a complex process which includes findings from clinical examination and imaging such as ultrasound and CT scanning. If cancer is suspected, oncologists then seek confirmation. This confirmation requires a biopsy whereby a core of tissue from a suspicious lump is analysed in the laboratory by histopathologists.

Explaining the process of diagnosis and treatment, Dr Joseph comments that if the diagnosis of cancer is confirmed, histopathologists then perform additional tests called immunohistochemistry which look to see if the cancer cells express certain proteins (called receptors) that may influence treatment.

Routinely immunohistochemistry is performed for hormone receptors (Oestrogen and Progesterone) as well as another protein called HER2/neu. If the hormone receptors are expressed oncologists will offer anti-oestrogen hormonal treatment while if the HER2/neu protein is over-expressed, patients will be treated with novel agents which specially target cancer cells. These drugs reduce the risk of cancer recurrence by 50% in tumours over-expressing the HER2/neu protein.

However, in some instances (approximately 10%) it is not possible to confirm whether the HER2/neu protein is abnormally expressed or not based on immunohistochemistry alone. When this happens the histopathologist reports it as an “equivocal” expression of the HER2/neu protein. It is uncertain if these patients will benefit from the novel targeted drugs mentioned previously and further molecular testing is needed for confirmation.

For these patients, one needs to check if the HER2/neu gene is present in abnormal amounts in the cancer cells. This is known as gene amplification. Testing for gene amplification is done by special techniques called in situ hybridization (ISH). About 50% of patients with equivocal expression of HER2/neu on immunohistochemistry will have gene amplification confirmed by molecular testing thus making them suitable for treatment with the novel targeted drugs.

Currently these molecular tests are available at a few private hospitals but not in the histopathology laboratories of government hospitals. As many patients cannot afford funding for these tests in the private sector, they miss out on potentially life- saving treatment.Molecular testing for HER2/Neu at the Teaching Hospital , Anuradhapura In recent times, molecular testing for HER2/neu gene amplification using available equipment has been established in certain government sector hospitals in the country.

The histopathology department of the Teaching Hospital of Anuradhapura is one such department which has the equipment and also staff that has been trained to perform the required tests. The problem however is the cost of the consumables that are required. According to Dr Joseph, to commence testing at Anuradhapura, the hospital would require a sum of US dollars 5,839 just to purchase the minimum quantities of reagents needed. It was this consideration that led Dr Joseph to reach out to Mithuruwela to request help in getting these funds.

In spite of the current challenging climate, Mithuruwela together with Dr Joseph and his contacts were able to collect the required funds, thanks to the generosity of donors such as the Tissa De Silva Trust, the Students Association of Edith Cowan University in Australia, well-wishers in Australia and New Zealand and a number of generous individuals in Sri Lanka. JL Morisons, the agents for the reagents also supported the cause by ensuring that the reagents reached Anuradhapura safely under refrigerated conditions.

The Anuradhapura Teaching Hospital is now in a position to commence molecular testing for HER2/neu. The tests will be carried out by Dr Jayanjana Ashanthi and Dr Sanjeewanie Jayawardena, Consultants to the histopathology laboratory at the Anuradhapura hospital.

Establishing testing for HER2/neu gene amplification at the Teaching Hospital of Anuradhapura will not only benefit patients with breast cancer, but will blaze a new trail for cancer diagnostics in Sri Lanka as it would be the first time ever that any form of molecular testing is performed in a laboratory attached to the Ministry of Health. Mithuruwela expressed its gratitude to all those who made this initiative a reality.