Firm will waive NHS fee for breast cancer test

The government is close to finalising an unprecedented deal with a British biotechnology firm that will allow NHS doctors to use a vital test for breast cancer without having to pay expensive patent fees.

The government is close to finalising an unprecedented deal with a British biotechnology firm that will allow NHS doctors to use a vital test for breast cancer without having to pay expensive patent fees.

Rosgen, the British licensee of the patents, is waiving royalties on all breast cancer tests based on the sequences of two human genes known to be involved in tumour formation.

The precise terms of the deal are being agreed but Rosgen said in an interim statement it intended to continue to let NHS laboratories test for the genes BRCA1 and BRCA2 without fear of being sued for patent infringement.

Rosgen said: "After constructive discussions between Rosgen and the Department of Health, Rosgen's position is that there should be no royalty charges - for either new or previous tests - or licence fees, and no cap on the number of tests performed by the NHS."

Leading medical geneticists had feared that Myriad Genetics, the American company that owns the patents on the breast cancer tests, would insist on charging royalties, so preventing wide use of the test.

Last February Myriad licensed the patents on the breast cancer tests to Rosgen, a commercial offshoot of the Roslin Institute near Edinburgh where Dolly the sheep was cloned.

John Burn, a professor of medical genetics at Newcastle University and a member of the Northern Genetics Service, has taken part in the negotiations. "Last year we issued 187 diagnostic test results for BRCA1 and a related gene, BRCA2. If we are asked to pay high royalties, that number must fall unless more money is found," he said. "We would have to refuse some women this valuable new test. This is exactly the type of situation which will arise if genetic information continues to be patented."

Some of Britain's leading cancer researchers involved in the discovery of the BRCA genes were angry that the patents could restrict use of a potentially life-saving test. Mutations in the BRCA1 and BRCA2 genes are known to be linked with inherited forms of breast and ovarian cancer in some patients. Young women testing positive are offered a preventive mastectomy.

Rosgen, however, insisted that it was never its intention - or that of Myriad Genetics - to stifle the use of the test by invoking its patent rights.

"Rosgen's aim is to introduce a commercial service that complements the service provided by the NHS, and they are currently in negotiations with the Department of Health on how best to achieve this," it said.

"The intention is that the NHS laboratories should continue to be able to provide BRCA testing services. The introduction of Rosgen's commercial services will give patients a wider choice of ways to access the test," it said.

It is believed that Rosgen will charge from £450 to £2,500 for private tests, which can range from identifying the presence of a single mutation to the full sequence of a patient's gene.

NHS patients will only be offered the test if they fulfil certain requirements, such as having one or more close relatives who have contracted breast cancer.

A spokeswoman for the Department of Health said that negotiations were continuing.