A costly US test that could spare some breast cancer patients debilitating chemotherapy will now be funded by the government, the Health Ministry has announced.

The decision to make the €3,000 Oncotype-DX test available for free was taken following an evaluation prompted by a breast cancer lobby group’s year-long campaign.

Patients eligible for the “crucial” test, which determines who would benefit from chemotherapy and who would not, must currently pay for it themselves.

But not everyone could afford it, Action for Breast Cancer Foundation has insisted.

It had also commissioned a feasibility study that suggested the clinically validated test could slash breast cancer chemo rates by 60 per cent and calculated it would also be financially beneficial, saving the government almost €100,000 a year.

The detailed report had shown that, each year, a number of patients in Malta were given chemotherapy for nothing.

“The decision to offer the test for free is rooted in its clinical advantages as it assists in determining the necessity of chemotherapy for certain breast cancer patients,” the ministry said.

“By providing the test for free, we aim to ensure that patients receive the most appropriate and tailored treatment, based on their individual medical needs.”

The tender process to provide this test from Maltese laboratories started immediately after its recent approval by the European Medicines Agency, and the procedure was regulated by public procurement regulations.

Health Minister Chris Fearne told Times of Malta the tender specifications were currently being drawn up to issue the call, although no timeframes were given.

By providing the test for free, we aim to ensure that patients receive the most appropriate and tailored treatment, based on their individual medical needs- Healthy Ministry

“This test is relatively new and gives an indication whether particular patients, who suffer from certain types of breast cancer, can benefit from chemotherapy or not,” Fearne said.

“We know that people react differently to this treatment… Some improve, while for others, unfortunately, it might do more harm,” he added.

To date, those eligible for the test not only have to pay thousands, but also go through onerous logistics and bureaucracy to get to know whether they need to undergo harsh treatment when they are diagnosed with a certain type of breast cancer.

But based on the test results, patients could now decide not to undergo chemotherapy, avoiding unnecessary toxicity and resuming normal daily activities earlier.

These were more likely to continue working or required less time off compared to those receiving the treatment, the study found.

It also looked at the “intangible” benefits, saying chemotherapy came with downsides that also had an economic price, including patients’ struggle with emotional, social and personal problems, as well as having to accept changes in their appearance.

During Breast Cancer Awareness Month last year, ABCF chairperson Esther Sant pushed for access to free and “fantastic” standard oncogenomics testing, which would significantly improve the quality of life of around 50 patients a year.

The genomic profile identified low-risk breast cancer patients, who could avoid chemo, while making sure those who were high risk would not forgo the treatment, Sant had explained.

Other European countries were offering the reimbursement of the costs of the Oncotype-DX test from public funds, and time was of the essence, the voluntary organisation had insisted.

US chemo test kit now in Malta

The Oncotype-DX test, owned by ExactScience, predicts how likely breast cancer is to spread within 10 years. It is analysed in the US for a genomic score used by doctors to target personalised cancer treatment.

Over the last eight months, a Maltese diagnostic lab, BioArte, has been working to attain a licence and be accredited to represent it in Malta.

This move means that although, as yet, still only available in the private sector, the test will cost €200 less – even as the lab takes on all the logistics and red tape to send a sample to the US, relieving oncologists and patients from the job and speeding up the process.

As things stand, the US has first to send the packaging and storage materials to Malta for the biopsy to be carefully transported there, explained Manuele Biazzo, CEO of BioArte at the Life Science Park.

Having an official distributor was considered “a great achievement for Malta”, Biazzo believed.

“The test is here. Now, let’s get it to patients for free,” he told Times of Malta.