ByDR. ITAY GAL
Urgent guidelines were issued to medical laboratories after a malfunction in Roche test kits was found. Laboratories are urged to destroy all stock of the faulty kits and conduct new tests.
Israel's Health Ministry issued urgent guidelines to all medical laboratories on Sunday evening following the discovery of a malfunction in Roche test kits used to identify hormonal receptors in cancerous tumors.
The malfunction may have led to misleading results, affecting the diagnosis of tumor type and treatment choices, particularly for breast cancer patients.
The test is designed to identify estrogen receptors (ER) and progesterone receptors (PR) in tumors and is one of the most important tests for determining treatment type. In these tests, a tissue sample from the tumor, obtained by biopsy or after surgery, is examined using immunohistochemistry (IHC).
A positive result indicates that tumor cells are "hormone-sensitive," meaning they can be treated with hormonal therapy, sometimes in place of chemotherapy, to block or reduce hormone levels in the body.
These are generally tumors that respond better to treatment and have a better prognosis. In contrast, a negative result indicates a lack of hormone receptors, requiring a different form of treatment.
Malfunction leading to decreased staining intensity
Roche reported the malfunction on August 29, noting a significant decrease in staining intensity in pathology samples used for diagnosis and treatment planning. As a result, users were instructed to stop using the faulty kits and destroy all remaining stock.
Roche's statement did not address patients for whom the test had already been performed. The company emphasized that no cases of patient harm had been reported in Israel or abroad from the use of kits from the two problematic batches.
It also noted that the clinical interpretation of any result must consider clinical history, morphological findings, and additional diagnostic tests, and that staining alone should not be the sole factor determining tumor type or absence.
The Health Ministry stressed that even a reduction in staining intensity could affect medical decisions, as a faulty result could lead to either unnecessary extra treatment or the avoidance of a treatment that might have been beneficial.
Therefore, the ministry instructed all laboratories in Israel to review all tests performed with kits from the faulty batches and to conduct retests where necessary. Laboratory reports will be updated accordingly, and doctors are required to inform patients of any changes in the results.
Dr. Hagar Mizrahi, head of the Health Ministry's Medical Division, instructed hospital and health fund managers to accurately map all cases in which the faulty kits were used and to report on all stained results, including the original outcomes, by November 5.
Laboratories were required to restain all cases with weak results, between 0 and +2 for breast tumors or negative results for other types of tumors. Additionally, laboratories were asked to send consolidated updates to the medical managers of health funds on any case in which a different result was obtained after retesting, and to send supplementary statistical reports to the Health Ministry on the scope of the changes.
The Health Ministry stated that it will continue to ensure the implementation of the guidelines across various laboratories and ensure that all relevant patients are informed by their doctors.
It emphasized its commitment to transparency, oversight, and keeping the public informed of any cases that might affect test results or treatment decisions.
