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N12Health

Genetic Test Glitch May Yield 100 False Negative Results

Translated & summarized from N12 by baba

CenterNeutral tone

Hebrew · 9 newsrooms covering

Israel's Ministry of Health reported a glitch in Gemidor's BRCA1 genetic test kits, potentially causing up to 100 false negative results out of over 90,000 tests. Affected individuals will be contacted for follow-up.

The story in 5 lines · by baba

  • Up to 100 false negative BRCA1 genetic test results suspected due to kit malfunction.
  • Over 90,000 tests were conducted using the faulty Gemidor kits.
  • The Ministry of Health will contact potentially affected individuals.
  • Gemidor has corrected the malfunction in its testing kits.
  • No need for the general public to contact labs independently.

The Israeli Ministry of Health announced on Tuesday a malfunction in a genetic test kit used to screen for BRCA1 gene mutations, potentially leading to approximately 100 incorrect negative results. The issue was identified in kits manufactured by Gemidor, which were used in over 90,000 tests.

Following the discovery of the glitch, health officials and Gemidor reviewed all tests conducted with the faulty kits. They identified around 100 samples where a false negative result is suspected. Individuals whose tests are among these 100 will be proactively contacted by the genetic institutes and laboratories where the tests were performed.

Gemidor has since corrected the malfunction in its kits. Those identified as potentially having received a false negative result may be asked to provide an additional blood sample for retesting. The Ministry of Health emphasized that the general public does not need to contact laboratories independently, as only those with potentially erroneous results will be reached out to.

The affected test is a "Nanochip" test, designed to detect common genetic changes, or mutations, in the BRCA1 gene. This gene is associated with an increased risk of certain cancers, including breast and ovarian cancer.

N12Centre · Neve Ilan

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