Health Ministry Reports Flaw in Genetic Test for BRCA1 Gene Mutations
Israel's Ministry of Health has announced a defect in a genetic test used to detect mutations in the BRCA1 gene, specifically with a testing kit manufactured by Gamidor. The reported issue raises concerns about the possibility of false negative results. Following the discovery and verification of the defect, the ministry initiated a review of all over 90,000 tests conducted using the faulty kit.
Gamidor, in collaboration with genetic institutes and laboratories, identified approximately 100 samples that may have yielded incorrect negative results. The company has since rectified the defect in the testing kit. The Ministry of Health stated that genetic institutes and laboratories will contact affected individuals in the coming days to request additional blood samples if necessary.
Individuals whose results are suspected to be false negatives will be contacted directly. The ministry advised that there is no need for all individuals who underwent the test to contact the laboratories or institutes themselves. The Nano-Chip test is designed to identify common genetic changes, or mutations, within the BRCA1 gene. The Ministry of Health pledged to keep the public informed of any further developments.
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