The Health Ministry has completed its investigation into a malfunction in the BRCA14 cancer screening test and confirmed that the issue was limited to two isolated cases, with no additional errors found in a nationwide review.
The probe was launched after two women, who initially tested negative for BRCA mutations, were later diagnosed with cancer and found, They were found, upon retesting, to carry the BRCA mutations, which are associated with a higher risk of breast and ovarian cancer.
The first case surfaced around two weeks ago, when a woman diagnosed with breast cancer received a positive result after retaking the test. A second similar case soon followed, prompting the Health Ministry to suspend use of the test and initiate an inquiry.
Fears that the issue may have affected thousands of women led the ministry to order a comprehensive review of test results and procedures nationwide. However, no further incorrect results were identified.
The BRCA14 nanochip test, developed by Israeli company Gamedor, is part of Israel’s national health basket and is offered free to women of Ashkenazi and Ethiopian descent who have not been diagnosed with cancer. The test screens for 14 known genetic mutations using a blood sample. It was introduced in 2021 for Ashkenazi women and extended in 2025 to include Ethiopian women.
The Health Ministry halted distribution of the test kits following the initial reports and examined all laboratories, genetic institutes, and health funds that used them, including Clalit, Maccabi, and Leumit. Ministry officials also consulted with geneticists and health fund administrators to review testing protocols and assess possible irregularities.
According to the ministry, the malfunction was due to a technical fault affecting one of the BRCA1 gene mutations. No additional faults were identified across the health system.
Health Ministry eyes stricter genetic test oversight
The incident highlighted the lack of an international reporting mechanism for faults in genetic testing kits distributed solely in Israel.
As a result, the Health Ministry is considering establishing a national fault-reporting protocol and requiring laboratories to adopt double-check systems and periodic control testing.
BRCA screening is a key tool in cancer prevention, as early detection enables close monitoring, preventive treatments, and, in some cases, preemptive surgery.
Gamedor said it is conducting an internal investigation and will submit its findings to the Health Ministry once the investigation is complete.