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Short-Read Sequencing 

BambniTest™
Non-Invasive Prenatal Testing

IVD Solution: PCR-Free, Accurate, and Scalable

Bring NIPT In-House with Confidence and Ease

BambniTest™ NIPT is an NGS-based technology transfer solution designed for the modern laboratory. Utilizing our patented PCR-free library preparation (EZ-PALO) and proprietary bioinformatics algorithm (RUPA), we enable laboratories to conduct in-house NIPT with minimal hands-on time and maximum accuracy.

Note: The methodologies used for BambniTest™ NIPT are different from SafeT21express offered in Xcelom Hong Kong.

The provided sequencing time is based on the Illumina NextSeq 500/NovaSeq 6000 systems and may vary across different sequencers.

Core Technology: The Advantage

At the core of BambniTest™ NIPT is EZ-PALO™, our patented rapid library preparation technology. Unlike standard NIPT methods that require time-consuming amplification and secondary purification, our method is completely PCR-free.

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  • No need for a dedicated pre-PCR clean room

  • Fewer steps and significantly reduced hands-on time

  • More uniform data without library amplification bias

  • Reduced cfDNA loss by eliminating the post-amplification purification step

Broad Scope, Flexible Reporting

BambniTest™ NIPT empowers you to define your own reporting scope based on local regulations and business strategy.

  • Detects aneuploidies and chromosomal CNVs down to 3 Mb resolution, including high-incidence conditions such as sex chromosome aneuploidies (SCAs) and 22q11.2 deletion syndrome

  • Customizable: Design your own reporting panel to match market demand and your commercial strategy

Proven Performance at Scale

BambniTest™ NIPT delivers outstanding test performance, validated by 1,008,703 cases with clinical follow-up information.​

Items

Sensitivity

Specificity

PPV

NPV

Trisomy 21

99.51%

99.97%

94.47%

99.99%

Trisomy 18

99.54%

99.98%

86.30%

99.99%

Trisomy 13

100.00%

99.97%

55.79%

100.00%

The positive cases (percentages) were 5,526 (0.55%) for Trisomy 21, 1,525 (0.18%) for Trisomy 18, and 313 (0.06%) for Trisomy 13.

Enhanced Precision: Paired-End (PE) Sequencing Upgrade

While Single-End (SE) sequencing remains a proven method for cost-efficiency, BambniTest™ NIPT now offers an optional upgrade to Paired-End (PE) Sequencing with bioinformatics size-based enrichment. 

 

This upgrade can distinguishes fetal DNA from maternal DNA based on fragment size to improves CNV calling without the drawbacks associated with wet-lab enrichment, such as poor ccfDNA recovery and specificity.

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In our internal parallel testing:

  • 60% fewer redraws and 30% lower test-failure rates

  • Accurate differentiation between maternal and fetal CNVs, significantly reducing false-positives and false-negatives

  • >60% reduction in false positives for sex chromosome aneuploidies

End-to-End Technology Transfer

Xcelom Limited and Berry Genomics provide an end-to-end turnkey solution for labs wishing to conduct this test in-house.

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  • Laboratory Setup: Full consultation

  • Workflow Integration: SOPs, IVD reagents, and staff training

  • Bioinformatics: Complete IVD software suite for sample management and automated report generation

NIPT reagent kit

Platform

illumina or Salus SBS sequencing system

Sample Type

Maternal blood

Operation Time

13/ 20 hours (hand-on 4 hours)

Automation 

Supported

Coverage

Detects aneuploidies and chromosomal CNVs down to 3 Mb resolution

The provided time is based on the Illumina NextSeq 500/NovaSeq 6000 systems and may vary across different labs and systems.

Resources

Brochure

References:

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