CE Marked

For In Vitro Diagnostic Use

The AneuVysion Multicolor DNA Probe Kit (Vysis CEP 18/X/Y - alpha satellite / LSI 13/21), which utilizes patented fluorescence in situ hybridization (FISH) technology applied to uncultured or cultured amniocytes, provides detection of trisomies 13, 18, and 21 (Down syndrome) and sex chromosome aneusomies in as little as 24 hours.

Together, trisomies 13, 18, and 21 (Down syndrome) and sex chromosome aneusomies account for nearly two-thirds of all abnormalities identified at the time of amniocentesis, and 85-90% of clinically significant chromosomal abnormalities detected in live-born infants. Review of AneuVysion testing of over 29,000 amniotic fluid samples has found that the test is 99.9% accurate for the detection of trisomies 13, 18, 21, and aneusomies of X and Y.


Aneuvysion Test Benefits

Because the results are rapidly available, within 24 hours after the amniocentesis sample is received in the laboratory (rather than 7-22 days for routine chromosome analysis), patients can benefit psychologically from a shorter time period of uncertainty. An expected AneuVysion result may allow patients a sense of relief in knowing that the majority of chromosome abnormalities for which their fetus was at risk have been ruled out with a very high degree of accuracy. Importantly, in accordance with professional standards, the availability of AneuVysion results along with consistent clinical information (i.e., fetal anomalies detected by ultrasonography) allows for pregnancy management options that otherwise might not be available due to late gestational age. Finally, in the rare case of a culture failure when standard cytogenetic results cannot be obtained, information on chromosome number for the most likely aneusomies is available.


AneuVysion Kit Contents

Each AneuVysion kit includes:

  • Five FISH probes packaged in two probe mixtures 
  • Wash reagents
  • DAPI counterstain
  • Package insert with detailed protocol information

Both Mixture #1 and Mixture #2 are complete with labeled probes and non-labeled blocking DNA in hybridization buffer.