PERTH, Australia – Researchers at Western Australia's Edith Cowan University (ECU) have developed the world's first blood test capable of detecting early-stage melanoma.

The breakthrough development, called the Meldx, could save thousands of lives, as well as millions of dollars for Australia's health system, Mel Ziman, head of the ECU Melanoma Research Group, said during a press conference.

The research team used the Oxford Gene Technology Array to compare 1,627 proteins to identify a combination of 10 antibodies that indicated the presence of melanoma. They then tested the blood of 105 melanoma patients and 104 healthy control patients and found 139 positive signals.

The blood test was able to detect early-stage melanoma in 79 percent of cases with a specificity of 84 percent.

The next step is a clinical trial in 1,000 patients to compare the test with a clinical determination of lesion before biopsy and then validate the finding.

Lead researcher and doctoral candidate Pauline Zaenker said identifying melanoma early was the best way to prevent these deaths.

"Patients who have their melanoma detected in its early stage have a five-year survival rate between 90 percent and 99 percent; whereas if it is not caught early, and it spreads around the body, the five-year survival rate drops to less than 50 percent," she said.

Australia, New Zealand have highest melanoma occurrence

Australia and New Zealand have the highest occurrence of melanoma anywhere in the world. It is the most common cancer among 15- to 39-year-olds in Australia, with 14,000 new diagnoses and almost 2,000 deaths each year.

Currently melanoma is detected by a visual scan by a clinician, and areas of skin that are of concern are excised and sent for a biopsy.

But relying on biopsies is invasive and painful, and they also cost the health system a fair amount of money, since about 70 percent of biopsies come back negative, Ziman said.

The Australian health system spends more than $200 million on melanoma each year with an additional $73 million on negative biopsies.

The blood test works by detecting the autoantibodies the body produces in response to the melanoma.

"The body starts producing these antibodies as soon as melanoma first develops, which is how we have been able to detect the cancer in its very early stages with this blood test. No other type of biomarker appears to be capable of detecting the cancer in blood at these early stages," Zaenker said.

The ultimate goal is for the test to be used to provide greater diagnostic certainty prior to biopsy and for routine screening of people who are at a higher risk of melanoma, such as those with a large number of moles or those with pale skin or a family history of the disease.

"We envision this taking about three years," Ziman told reporters. "If this is successful, we would hope to be able to have a test ready for use in pathology clinics shortly afterwards," she said.

"A sensitivity of 79 percent means that it will detect melanoma in 79 percent of affected people but miss it in 21 percent," said Rodney Sinclair, professor of Dermatology at the University of Melbourne.

"The specificity of 84 percent means that when the test is positive, 84 percent of patients will have a melanoma, but 16 percent won't. The false positive and false negative rates of this test mean that the results will need to be interpreted with caution and, where practical, combined with a full skin check by a dermatologist."

The research group plans to perfect the Meldx to bring it to at least 90 percent specificity.

"We may have to reconfigure some of the markers, but that's why we do the clinical trial, Ziman, said. "We want to be certain that our findings mirror those of the biopsy, which is the ultimate test."

"If we can cut out the melanoma when it is small and thin, patients have a 99 percent chance of never having melanoma again," she said.

The ECU team participated in the Center for Entrepreneurial Research and Innovation (CERI), a new project to train entrepreneurs to build start ups. CERI was supported by the Australian Government's Medical Technology and Pharmaceutical Industry Growth Center as part of a new incubator program to connect academia and industry within Australia.

The ECU Melanoma Research Group (MRG) received a A$200,000 (US$147,753) grant from the Cancer Council WA and A$820,000 from the National Health and Medical Research Fund to develop a blood test for early prediction of the effectiveness of different types of treatments for melanoma patients.

The MRG is also working on a blood test for melanoma of the eye.

Currently patients with this deadly form of cancer have to have a biopsy, which involves a needle to the eye.

Joint lead researcher Elin Gray said the test works by measuring the amount and type of circulating tumor cells and circulating tumor DNA in the patient's blood.

"By analyzing the genetic makeup of these CTCs we were able to give an accurate prognosis of whether the patient's melanoma was likely to metastasize throughout their body," she said.