The company that provided SA Pathology with testing kits that returned false positive results for dozens of prostate cancer patients has denied its kits were at fault.
About 100 South Australian men were left fearing they had prostate cancer earlier this year, despite the fact they had already had their prostate glands removed, after test results incorrectly showed elevated prostate specific antigen (PSA) levels.
The error was picked up when an Adelaide urologist ordered fresh testing of some of his patients.
Siemens, which provides testing kits to SA Pathology, said an internal investigation found its kits were not faulty.
“Our investigation and review shows that our test kit is not faulty, the assay is performing as it is designed to perform and we are working closely with relevant authorities to support them in any way they need,” the company’s statement said.
“This test kit is not intended to be used to make a definitive diagnosis of recurrence of prostate cancer.
“It is an aid in the detection, monitoring and management of prostate cancer, when used in accordance with the product labelling.”
The company said it was continuing to support the SA Government with its investigation.
But a spokesperson for Health Minister Jack Snelling said doctors had indicated the kits could be the cause of the error.
An announcement on who will conduct an independent investigation into the bungle is expected later today.