Applied Imaging Corporation Awarded US Patent for Fetal Cell Analysis Technology

Strategic Insights -

Applied Imaging Corporation, a leading developer of automated clinical analysis systems, has been awarded a US Patent central to its fetal cell analysis technology. The patent, titled "Method for Separating Rare Cells from a Population of Cells", was awarded to Alexander Saunders, Michael Zarowitz, and Patricia Baldwin, scientists at AIC. This technology has the potential to revolutionize prenatal detection of genetic abnormalities, enabling routine analysis of fetal cells from maternal blood.

Key Takeaways:

  • The patented technology enriches or concentrates nucleated cells from a sample of peripheral blood, allowing microscopic analysis of the cells using DNA probes or antibodies.
  • The technology has the potential to detect common genetic abnormalities in fetuses, with a detection rate that could surpass other currently utilized screening techniques.
  • The main advantages of AIC's technology include safe, accurate, and inexpensive prenatal chromosome screening.
  • The company has completed a $4.65 million round of financing to conduct multicenter clinical trials and achieve regulatory approval of the technology.
  • Applied Imaging has received a $550,000 matching grant from the Israel-U.S. Binational Industrial Research & Development (BIRD) Foundation to refine and expand elements of the process.
  • The company has approximately 400 customers in over 30 countries and markets its products worldwide.

Statistics:

  • Over 2 million screening tests are performed annually in the U.S. for the detection of common chromosomal abnormalities.
  • Currently, pregnant women age 35 or older are offered amniocentesis or chorionic villus sampling (CVS) with karyotyping, while women under age 35 are offered a blood test called serum screening or the "Triple Test".
  • The main drawback of amniocentesis and CVS is the 0.5-2% risk of fetal loss induced by the procedure and the cost, which is usually over $1,000.
  • The main disadvantage of serum screening includes a high false positive rate, leading to unnecessary anxiety and further prenatal testing procedures.

Sources:

  • Applied Imaging Corporation
  • U.S. Patent 5,432,054
  • Robert Risacher, Vice President of Genetic Diagnostics
  • Israel-U.S. Binational Industrial Research & Development (BIRD) Foundation