Faulty self-test bowel cancer kits

The Department of Health and Ageing will start contacting participants in the National Bowel Cancer Screening Program to invite people to re-take the test, after quality issues were identified during an investigation of the test kits.

The Department has recently observed that the level of positive results in tests performed since 1 December 2008 is lower than expected.

The Department has reviewed the reliability of the test kits under certain conditions.

108,000 people have undertaken tests since this time and have returned a negative result and will be asked to repeat the test with a new kit.

The Department will write to all 475,000 people who have received the test kits since 1 December 2008, although many have not yet used the test and returned it for assessment.

It is expected it will take no longer than two weeks to contact all affected people. New test kits will then be issued as they become available in coming weeks.

People who have used the screening kit and have received a positive result are not affected. Anyone with a positive result should, if they have not already done so, see their doctor to arrange further investigation.

The Department is in urgent discussions with Dorevitch Pathology, the supplier of the test kits, to verify the cause of the problem and ensure that new, reliable tests are available as soon as possible.

The test kits are manufactured by Japan-based Fujirebio Diagnostics, imported into Australia by Siemens Medical Healthcare Diagnostics, and supplied to the Department by Dorevitch Pathology.

Preliminary investigations indicate that recent changes to the kit contents by Fujirebio may be the cause of the test result discrepancies.

For further information on screening status, members of the public who have received test kits since 1 December 2008 should contact Dorevitch Pathology on 1300 738 365.

Information about re-testing options is available at www.health.gov.au