Cell3TM Direct Fetal Sex Determination Kit

Reduce Cost & Time in Fetal Sex Determination Using Cell Free Fetal DNA

With no cfDNA extraction required, Cell3TM Direct reduces cost and saves time in fetal sex determination from sample to result in under 3 hours. The knowledge of fetal gender is critical to management of pregnancies at higher risk of sex-linked disorders.

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Save Time and Reduce Cost

With no cfDNA extraction required, it takes under 3 hours from sample receipt to result.

Less Material Required

Uses less than 0.25ml of plasma sample, leaving plenty of sample left for further tests.

Fully Validated

Validated kit and flexible format to fit with laboratory processing. Multiple targeted approach to provide intra assay concordance.

Robust and Accurate Reporting

96 well formatting within a break-apart plate allows for testing of up to 13 samples per kit. Validated protocol ensures accurate reporting of findings.

Improving Patient Pathways

Utilizing circulating cell free fetal DNA (cffDNA), which can be detected in maternal plasma from early in gestation, and through the use of our proprietary Cell3™ amplification technology the Cell3™ Direct Fetal Sex Determination kit accurately reports fetal sex early in pregnancy without the need for invasive procedures.

A New Benchmark in Simplicity

The Cell3™ Direct Fetal Sex Determination Kit is the first commercially available direct from plasma non-invasive prenatal test for fetal sex determination. This kit sets a new benchmark in simplicity of setup with results generated within 3 hours from sample receipt. The protocol offers significantly reduced hands-on time due to no sample extraction requirement and flexible pre-plated assay.

Superior technical performance

Technical sensitivity of our assay was demonstrated using male genomic DNA spiked into a female genomic DNA background at fixed percentages (10%, 5% and 1% or 30, 15 and 3 genomic equivalents) to reproduce realistic fetal fractions and confirm the sensitivity of the assay. Amplification of all targets across all replicates was observed even at the lowest 1% spike-in fraction.

Direct from plasma protocol was compared with extracted cfDNA and comparable results were demonstrated using the same sample (male pregnancy, 10 weeks’ gestation). Amplification plots of direct from plasma testing shows robust amplification of all targets: SRY (blue), DAZ (red), TSPY (green) and CCR5 (black).

 

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