Health Ministry reports failure in production of laboratory tests for cancer diagnostics

The Ministry of Health received information this week about a failure in the production of several batches of Rabbit Monoclonal Primary Antibody laboratory tests produced by Roche. These tests are used to assist in laboratory diagnosis of cancer.

According to the manufacturer, as a result of this failure, some tests may give a false positive result in the process of diagnosing oncological diseases, and as a result, a decision may be made to conduct treatment incompatible with the real diagnosis. The press service of the Ministry of Health emphasizes that this is a small percentage of risk.

The report states that the test is only one part of the diagnostic process for some oncological diseases, along with examination, additional studies, etc. – thus, this test alone is not sufficient to diagnose cancer.

After consultation, the experts decided that an experienced and qualified pathologist would be able to determine that the test result was false positive. However, the Ministry of Health has instructed hospitals to review cases in which the above tests yielded positive results and to report how many cases of misdiagnosis were identified.