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™ and PE anaylsis), 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
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Fewer steps and significantly reduced hands-on time
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More uniform data without library amplification bias
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Reduced cfDNA loss by eliminating the post-amplification purification step
Enhanced Precision: Paired-End NIPT (PE-NIPT)
While Single-End remains a proven NIPT approach, BambniTest™ NIPT now offers an upgraded PE-NIPT with bioinformatics size-based enrichment. This upgrade can distinguish fetal DNA from maternal DNA based on fragment size to improve CNV calling without the drawbacks associated with wet-lab enrichment, such as poor ccfDNA recovery and specificity.
In a comparative study between SE-NIPT and PE-NIPT¹:
Reduced Redraw Rates for Low Fetal Fraction
Fragment size selection via PE-NIPT effectively rescues samples with low fetal fraction (%FF). In a cohort of 37 samples with an initial %FF of 2.4%–3.8% (SE-NIPT), PE-NIPT enriched the %FF to 5.9%–11.3% to meet QC thresholds for downstream analysis.
False-Positive Reduction
PE-NIPT differentiates fetal from maternal origins of CNV abnormalities, effectively eliminating false positives driven by maternal genomic background. In a evaluation of SE-NIPT positive cases that further validated by karyotyping or FISH, PE-NIPT reduced false-positive calls by >80% while maintaining high sensitivity (0 false negatives).
Broad Scope, Flexible Reporting
Laboratories can fully tailor the reporting range and report formats under the below offering to match local market demand and commercial strategy.
NIPT Basic
Detects chromosomal aneuploidies in all chromosomes, including Trisomies 21, 18, and 13, as well as sex chromosome aneuploidies (SCAs)
NIPT Plus
Includes all NIPT Basic targets plus genome-wide copy number variations (CNVs >3 Mb). Proprietary software annotates CNVs across 178 associated conditions and reports non-annotated CNVs (>3 Mb, falling outside these defined conditions) with ACMG pathogenicity classification
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.
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 and support
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Workflow Integration: SOPs, IVD reagents, and staff training
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Bioinformatics: Complete software suite for sample management and automated report generation
Platform
Illumina or Salus SBS sequencing system
Sample Type
Maternal blood from pregnant women (including twins and IVF pregnancies)
Operation Time
23 hours (hand-on 4.5 hours)
Automation
Validated in Tecan + KingFisher System, or Jiangsu Kunqi NEA24 + Revo24D System
Coverage
Detects chromosomal aneuploidies and copy number variations (CNVs) down to 3 Mb resolution across 178 associated conditions, with optional direct reporting of detected CNVs fragment.
The provided time is based on the Illumina NextSeq 500/NovaSeq 6000 systems and may vary across different labs and systems.
References:
[1] Yang L, Zhang J, Zhang J, et al. In Silico Fragment Size Selection for Enhanced Fetal Fraction and Abnormality Origin Discernment Using Pair-End Sequencing of Maternal Plasma DNA. J Clin Lab Anal. 2026;40(13):e70233