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    OUR LAB

    Built for Precision,
    Quality & Transparency

    Our laboratory integrates advanced molecular workflows, NGS
    technology, and computational analytics to deliver oncology insights that
    are reliable and clinically actionable.

    FACILITY OVERVIEW

    Inside the 1Cell.Ai Lab

    The laboratory is designed for high-complexity molecular diagnostics, with
    stringent contamination controls, optimized workflow zoning, and multi-layer quality checks to ensure reliable and reproducible results.

    Validated wet-lab workflows are seamlessly integrated with advanced bioinformatics and standardized clinical interpretation frameworks.

    From sample accessioning to clinical reporting —
    see how precision is built into every step.

    LABORATORY WORKFLOW OVERVIEW

    Sample Accessioning & QC

    ID verification, QC checks, storage

    Intake

    Analyte Isolation / Nucleic Acid Extraction

    Isolation of ccfDNA, gDNA, FFPE-derived DNA & RNA

    Wet Lab

    Library Preparation

    NGS library construction

    Wet Lab

    NGS Sequencing

    Molecular profiling & variant detection

    Genomics

    Bioinformatics Analysis

    Pipeline, annotation, classification

    Computational

    Clinical Interpretation

    Report generation & validation

    Clinical

    PRECISION WORKFLOW

    Every Step, Engineered

    Sample Accessioning & QC

    Identity verification, viability assessment, and pre-analytical QC

    CTC / ctDNA Isolation

    Validated enrichment and high-
    sensitivity extraction protocols

    Library Preparation

    Targeted NGS library construction with
    rigorous QC checkpoints

    NGS Sequencing & Molecular Profiling

    High-depth sequencing with real-time
    quality monitoring

    Bioinformatics Analysis

    Validated pipelines: alignment, calling,
    annotation, AI prioritization

    Clinical Interpretation & Reporting

    Evidence-based variant classification
    and structured oncology reporting

    INSIDE OUR LABORATORY

    A Lab Built for
    Clinical Precision

    From sample intake to molecular reporting, explore how our laboratory delivers precision at every stage.

    SCIENTIFIC LEADERSHIP

    Pune Laboratory

    Dr. Hrishita Kothavade

    Pune Laboratory Director

    A pathology professional with expertise in laboratory administration, histopathology, immunohistochemistry, and cytology. Experienced in frozen section reporting and supporting multidisciplinary tumor board discussions for accurate and timely clinical decision-making.

    • Laboratory Administration
    • Histopathology
    • Immunohistochemistry (IHC)
    • Frozen Section Reporting
    • Tumor Board Coordination

    US Laboratory

    Dr. Ken Bloom

    US Laboratory Director

    A seasoned healthcare executive with deep expertise in oncology, diagnostics, and precision medicine. Experienced in leading large-scale clinical programs, advancing genomic technologies, and driving strategic growth across life sciences and healthcare organizations.

    • Lab Innovation
    • Genomic Diagnostics
    • Clinical Research
    • Strategic Leadership
    • Precision Oncology

    CORE CAPABILITIES

    What We're Built to Do

    06 Capabilities

    NGS-Based Liquid Biopsy

    Advanced molecular profiling using ctDNA and CTC
    analysis with high sensitivity and clinical-grade
    reproducibility.

    01

    Single-Cell Resolution

    Characterizing tumor heterogeneity at the cellular level to
    capture the full landscape of genomic diversity within a
    tumor.

    02

    AI-Assisted Interpretation

    Machine-learning enhanced variant prioritization and
    panel optimization, reducing noise and surfacing clinically
    significant findings.

    03

    Bioinformatics Infrastructure

    Robust validated pipelines for variant calling, annotation,
    and oncology-grade reporting against curated genomic
    databases.

    04

    Lab Workflow Intelligence

    Digitized, traceable sample lifecycle management with
    real-time monitoring and automated QC checkpoints
    across all stages.

    05

    Scalable Operations

    Designed for reproducibility and growth — standardized
    protocols, modular infrastructure, and institutional QMS
    integration.

    06

    INFRASTRUCTURE & TECHNOLOGY

    Technology Stack

    Our lab is designed from the ground up to support high-complexity oncology diagnostics. From sample accessioning to bioinformatics interpretation, every step is optimized for accuracy, reproducibility, and scalability.

    SYSTEM ARCHITECTURE

    Pre-Analytical Module

    Sample accessioning, QC, storage management

    Wet Lab Automation

    Isolation, extraction, library prep workflows

    Sequencing Platform

    NGS instrumentation with real-time monitoring

    Bioinformatics Engine

    Alignment, calling, annotation pipelines

    AI Intelligence Layer

    ML-assisted variant prioritization and classification

    Clinical Reporting Layer

    Structured reports, physician delivery, audit trail

    QUALITY ASSURANCE

    Lab Performance Snapshot

    Indicative framework — validated metrics published upon accreditation

    Accreditations

    NABL

    ISO 15189 · Molecular Diagnostics

    CAP

    College of American Pathologists

    International and national accreditation ensuring laboratory excellence and clinical-
    grade reliability across all molecular assays.

    Median Turnaround Time

    10–12 days

    NGS-based molecular assays (working days from sample receipt to report delivery)

    Tissue Biopsy NGS 10–12 days
    Liquid Biopsy NGS 10–12 days

    On-Time Reporting

    95 %

    of samples reported within committed
    TAT window

    QC Pass Rate

    98 %

    of samples clear all quality checkpoints

    Analytical Performance

    Sensitivity

    ≥99 %

    Specificity

    ≥99.9 %

    Validated across target oncology panels using orthogonal confirmation methods.

    Limit of Detection (VAF)

    Tissue Biopsy

    1 % VAF

    Liquid Biopsy

    0.1 % VAF

    Variant allele frequency detection limits optimized per assay type and clinical context.

    Tissue Biopsy Depth

    2,000

    × mean depth

    High-depth somatic profiling, SNV ·
    INDEL · CNV

    Liquid Biopsy Depth

    10,000

    × mean depth

    Ultra-deep sequencing for ctDNA at low VAF

    Reliability Metrics

    QC Pass Rate 98%
    On-Time Reporting 95%
    Repeat Rate <2–3%
    Analytical Sensitivity ≥99%

    Variant Interpretation Standards

    All molecular findings are classified and reported in alignment with internationally
    recognized evidence-based guidelines.

    Variants tiered according to clinical significance and therapeutic actionability per
    standardized classification frameworks.

    Quality Control Infrastructure

    Control Layers

    6+

    Independent QC stages across the full
    assay lifecycle

    Specificity

    3x

    Physically separated workflow zones
    with unidirectional flow

    Repeat Rate

    <2–3 %

    Low repeat rate reflects robust pre-analytical controls, library optimization, and run
    quality monitoring. Continuously tracked under the laboratory QMS.

    Metrics are assay- and indication-dependent and are continuously monitored as part of the laboratory quality management system.
    Values represent validated performance ranges and may vary by panel, sample type, and clinical context.

    1Cell.Ai
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