BRCA1 Genetic Test Flaw May Have Caused 100 False Negative Results

Israel's Ministry of Health announced Tuesday a malfunction in a BRCA1 genetic carrier test kit produced by the company Gemidor, raising concerns of up to 100 individuals receiving incorrect "false negative" results. These results would indicate a person is not a carrier of the gene mutation when they actually are.

The malfunction was discovered after a review of over 90,000 tests conducted using the faulty kit. Gemidor, in conjunction with genetic institutes and laboratories, identified approximately 100 samples where a false negative result is suspected. The company has since corrected the technical issue.

Genetic institutes and laboratories that used the defective kit will contact the affected individuals in the coming days. Those identified as potentially having received a false negative result may be asked to provide an additional blood sample for retesting. The Ministry advised that individuals who have taken the test do not need to contact the labs themselves, as proactive outreach will be conducted.

This is not the first time Gemidor's BRCA testing kit has faced scrutiny. In October 2025, the Ministry of Health launched an investigation into the kit following reports of two women who received negative results but were later found to be carriers of BRCA gene mutations. One case involved a woman with breast cancer who received a positive result upon retesting, and the second was identified through a retrospective review by a health maintenance organization.

At that time, the source of the malfunction was unknown, with possibilities including issues with the kit itself, the test analysis, or a specific batch. The Ministry had then instructed institutes and labs to halt the use of the BRCA 14 nano-chip kit pending further investigation. Mutations in the BRCA1 and BRCA2 genes are known to increase the risk of developing certain cancers, including breast and ovarian cancers.