Ministry of Health Warns of False Negative Results in 100 BRCA1 Genetic Tests
The Ministry of Health reported a malfunction in Gemidor BRCA1 genetic screening kits, risking 100 false negative results out of 90,000 tests. Affected individuals will be proactively contacted for re-testing.
The Ministry of Health announced today, Tuesday, that a report was received regarding a malfunction in genetic carrier testing for the BRCA1 gene, which identifies the risk of breast and ovarian cancer: there is concern over 100 erroneous results conducted using a kit from the company Gemidor. Following the malfunction, concerns arose regarding receiving a false negative result, meaning a result that fails to identify an existing carrier state.
Upon learning of the incident and after clarifying the nature of the malfunction, the results of all tested individuals using the faulty kit were reviewed. In total, over 90,000 tests were examined, and Gemidor, alongside genetic institutes and laboratories, identified 100 samples with a risk of a false negative result. Meanwhile, the company has corrected the malfunction.
Official Guidance and Patient Contact
«In the coming days, the genetic institutes and laboratories where the tests were performed using the faulty kit will contact the relevant tested individuals and, if necessary, invite them to provide an additional blood sample,» the Ministry of Health clarified.
Since proactive outreach will be conducted for those at risk of receiving a false negative result, there is no need for everyone who took the test to contact the laboratory or the genetic institute where they were tested. The nano-chip test is a genetic screening test designed to detect common genetic changes, known as mutations, in the BRCA1 gene.
Investigation Background
As published in October 2025, the Ministry of Health opened an investigation into a suspected malfunction in Gemidor's genetic screening kit after two women who received negative results were later found to be carriers of mutations in the BRCA genes. One case was discovered after a woman who developed breast cancer underwent a re-test and received a positive result. The second case was identified during a retrospective review conducted by one of the health maintenance organizations.
At the time, the Ministry of Health announced that the source of the malfunction was still unknown and that possibilities including a problem with the kit itself, test interpretation, or a specific batch were being examined. The Ministry instructed institutes and laboratories to suspend the use of the BRCA 14 nano-chip kit until the investigation was completed.
Mutations in the BRCA1 and BRCA2 genes can increase the risk of developing various types of cancer, including breast and ovarian cancer. The screening test is designed to detect common mutations, and a positive result requires further investigation and medical follow-up according to the medical team's recommendations.
