A severe malfunction in cancer diagnosis devices: Roche, a large pharmaceutical equipment company, reported to the Health Ministry that a series of devices assisting in the laboratory diagnosis of cancerous tumors experienced a malfunction, meaning there was a rare risk of receiving false positive results and inappropriate treatments.
Roche, a leading pharmaceutical and diagnostics company, is known for its contributions to cancer research and treatment.
The malfunction was reported to the Health Ministry this week after hospitals found discrepancies between the test device results and additional findings from other tests on patients.
Roche investigated and found that there was indeed a malfunction in a batch of laboratory tests for some cancerous tumors.
These tests are part of a testing array but can be highly significant in determining the type of tumor and the treatment provided.
The malfunction implies that patients might have received a false positive result for a specific type of cancer—when the cancerous tumor is different, or it is not cancerous at all—and received incorrect treatment.
Extent of malfunction is unclear
The extent of the malfunction is still unclear, and the ministry does not yet know how many patients were affected as a result of the malfunction. However, the Health Ministry emphasized that this test is only part of the diagnostic process for certain tumorous diseases and that additional tests are used to diagnose cancer.
A statement from the Health Ministry read: "After consulting with professional authorities in the ministry and experts in the field of pathology, it appears that a certified and skilled pathologist can identify the incorrect diagnosis. However, the head of the medical division instructed hospitals to review cases where a positive result was received and to update the ministry if there were cases of incorrect diagnosis."