Days after announcing a malfunction with cancer tests, the Health Ministry announced a serious glitch in the BRCA nanochip test, which tests for a genetic mutation that significantly raises the risk of developing ovarian or breast cancer.
On Tuesday, the Health Ministry launched an investigation into an unusual case involving a widely used genetic screening test centering on the BRCA14 nanochip test, which identifies mutations in the BRCA1 and BRCA2 genes.
The issue emerged after a woman who initially tested negative for the mutations later developed breast cancer and was found to have a positive result after retaking the test. This incident led to the discovery of a similar case, prompting an official investigation.
The BRCA 14 nano-chip test, which is common in Israel, targets women of Ashkenazi and Ethiopian descent who have not been diagnosed with cancer. The test detects 14 known genetic mutations linked to increased cancer risk and is administered via a blood sample. It is recommended for women aged 25 and older, following genetic counseling.
According to the ministry, the test was used between August 2024 and January 2025 at various health funds, including Clalit, Maccabi, and Leumit, as well as in hospitals like Beilinson, Soroka, Nahariya, Afula, Carmel, Meir, and Kaplan.
Upon receiving the report, the ministry began an investigation with the test’s developers, laboratories, and genetic institutes to determine whether the malfunction originated from the kit itself or from the algorithm used to analyze the samples.
The primary concern is that some tests may have returned false-negative results, indicating no mutation when one was actually present. Preliminary information suggests the issue may be linked to one of the mutations in the BRCA1 gene. While the exact number of affected women is still unclear, the incident is believed to be isolated.
The consequences of a false-negative result are serious. Women who received incorrect negative results may not be aware of their elevated cancer risk and, as a result, could miss out on necessary medical follow-up or preventive screenings. In contrast, a positive result would indicate a mutation carrier, which would prompt more intensive monitoring and, in some cases, preventive treatments or surgeries.
In 2021, the BRCA test was added to the health benefits package for women of Ashkenazi descent, and the recommendation was expanded in September 2025 to include women of Ethiopian descent. A new test kit, the BRCA 16 nano-chip, was introduced, which includes 16 mutations.
In light of suspicions of a malfunction, the Health Ministry ordered the suspension of the BRCA 14 nanochip test at all laboratories and institutes across Israel. The ministry requested within 48 hours a detailed report on testing procedures, criteria for retesting, and the frequency of control tests conducted. Initial guidelines have been issued to the testing bodies.
At this stage, there is no blanket recommendation for women who have undergone the test to retake it, pending the completion of the ministry’s comprehensive investigation. Once the inquiry is concluded, a decision will be made on whether retesting is necessary and, if so, under what conditions.
The ministry reported that the test’s developers are cooperating with its teams to examine the cause of the malfunction. Until the investigation is complete, the use of the test has been fully suspended.
The ministry emphasized that, based on current knowledge, this appears to be an isolated incident. However, due to the sensitive nature of the issue and its potential impact on many women, the investigation is being conducted with urgency.