Full Portfolio.
Browse the complete BiQadx R&D portfolio — instruments, cartridge systems, consumables, digital platforms, and technical documentation. All content is stage-tagged R&D. No clinical claims.
Built On Proven Disciplines.
Ten interlocking scientific disciplines form the technical foundation of every BiQadx platform. (R&D Stage)
Siphon-valve disc geometry exploiting rotational frequency as the sole pumping mechanism — no active valves, no external pumps.
Standing 2 MHz acoustic fields stratify cells by compressibility contrast factor (Φ) — lysis-free, label-free, >97% purity target.
Trehalose/sucrose glassy matrix (Tg >55°C) encapsulates enzymes and probes — >24-month ambient storage, <1% moisture by KF titration.
COP substrate fluorescence suppressed 8× vs PMMA at 488 nm excitation — enabling sub-picomolar detection without time-gating.
INT8-quantised transformer on ARM Cortex-M7 interprets multi-channel fluorescence decay curves — <18 ms latency, zero cloud dependency.
Bidirectional HL7 FHIR R4 integration for hospital LIS/LIMS, supporting real-time result push and patient record linkage (concept).
Screen-printed enzyme electrodes using DPV readout — sub-nanomolar sensitivity without optical components for metabolite panels.
FMEA covering hardware, process, and software fault trees — risk register maintained from DHF initiation through each gate review.
Isothermal LAMP at 62°C achieves RT-PCR-equivalent sensitivity for 6 simultaneous respiratory targets in <45 min without thermocycling.
Full Design History File (DHF) from concept stage — no retroactive documentation. Design controls enforced at every milestone gate.
Hardware Platforms.
Modular, scalable hardware from decentralised point-of-care to core-lab throughput. All content R&D stage tagged. No clinical claims.
Dr. POCT™
Modular Point-of-Care Analyzer
Modular point-of-care analyzer concept with cartridge families, dual-sensor optics, and an orchestration layer for decentralized diagnostics.
- LIMS/AI orchestration hooks and traceability ID framework (concept)
- Dual-sensor optical bench concept for multiplexed amplification curves
- Embedded Wi-Fi 6 + BLE 5.2 for real-time hospital LIMS sync
Optical Bench (Concept)
Multi-channel fluorescence sensing array concept for multiplexed amplification curves.
Thermal Block (Concept)
Peltier-driven active heating/cooling concept with fast ramp rate planning.
Microfluidic Actuator (Concept)
Precision stepper motor concept for valving and pneumatic blister actuation.
Edge Connectivity (Concept)
Embedded Wi-Fi 6 + BLE 5.2 concept for hospital network and LIMS sync.
R&D-stage content only. No clinical claims. No performance guarantees.
Catalogue Specification
| Catalogue ID | BQ-INST-POCT-001 |
| Stage | R&D |
| Platform class | Decentralized / Point-of-Care |
| Primary carrier | POCT cartridge families (concept) |
| Connectivity concept | Wi-Fi 6 + BLE 5.2 + LIMS API |
| Versioning | v2.1.0-alpha (R&D internal) |
Program Overview.
A disciplined, milestone-gated progression from architecture lock through IVDR-aligned market readiness — each phase requiring a signed evidence package before promotion.
Core system architecture defined for HELIX ONE instrument family. Requirements traceability matrix established. CAD models for centrifugal disc geometry finalized. Risk register and FMEA initiated across all three engineering domains.
Gate criteria: Design input freeze, risk classification (Class IIa IVD) assigned per IVDR 2017/746, DHF structure approved by QA.
- Requirements Traceability Matrix v1.0
- FMEA draft — hardware, chemistry, software
- Centrifugal disc CAD geometry v2.1
Simultaneous development across hardware mechanics, assay chemistry, and LIMS/AI software architecture. Four hardware platforms initiated from DHF baseline. Lyophilisation formulation screening commenced across 5 matrix variants.
Gate criteria: Platform concept feasibility reviews signed. TRL 3 bench evidence documented for each discipline.
- Platform architecture briefs (4× instruments)
- Lyophilisation screening report — DSC Tg data
- LIMS AI architecture design v0.5
Alpha hardware units assembled for bench-level integration testing. IQ/OQ protocol drafting begins. Assay chemistry enters microfluidic compatibility validation. Acoustic separation module bench characterization for PZT-5A resonant frequency matching.
Gate criteria: IQ/OQ protocols approved. Alpha unit bench performance meets TRL 4 evidence package criteria.
- Alpha instrument units (IQ/OQ tested)
- Assay-microfluidic compatibility report
- Acoustic separation bench characterization
Controlled external site deployment at partner institutions under strict site management plan. Operator training and Human Factors Engineering evaluation. CAPA system activated. Prospective data collection for validation report.
Gate criteria: Site Management Plan approved. ≥200 samples collected per assay panel. CAPA closure rate ≥90%.
- Site Management Plan + training materials
- Human Factors Engineering study report
- Prospective validation dataset (pilot)
Regulatory submission strategy initiated under ISO 13485 QMS. Technical File compilation for IVDR CE-IVD. Commercial production planning and supply chain qualification. International distribution architecture across three geographies defined.
Gate criteria: Technical File approved by Notified Body. QMS certified to ISO 13485. Commercial launch plan signed off.
- IVDR Technical File (CE-IVD pathway)
- Commercial production + supply chain plan
- Distribution architecture (3 geographies)
25 Active Programs.
Dr. POCT
PrototypeCompact immunoassay platform designed for decentralized environments, bringing lab-grade precision to the point of care.
EtherX-1
R&DHigh-throughput modular system engineered for core laboratories with advanced microfluidic handling.
Vital+Gas Console
PilotAdvanced blood gas and electrolyte analyzer designed for critical care environments.
HemoCount XR
PlannedNext-generation complete blood count (CBC) analyzer leveraging AI-driven optical cytometry for precise cell differentiation.
OmniSense PCR
ConceptRapid, multiplexed molecular diagnostic platform aimed at syndromic panel testing at the point of need.
TissueScanner Pro
R&DHigh-resolution digital pathology slide scanner designed to integrate seamlessly into LIMS for remote AI analysis.
HELIX ONE
R&DIntegrated molecular diagnostic and immunology system designed for mid-volume hospital laboratories.
EcoBio Labware
ConceptNext-generation biodegradable diagnostic consumables and labware crafted from plant-derived biopolymers — engineered for zero-waste, high-precision diagnostic workflows.
Standard Test Cartridge (STC)
PrototypeMicrofluidic cassette engineered for rapid near-patient immunoassay testing. Features integrated lyophilized reagents for cardiac markers.
Sepsis Alert Cartridge (SAC)
R&DAdvanced multiplex cartridge combining PCT (Procalcitonin) and IL-6 within a 15-minute timeframe for critical care screening.
EtherX CMP Disc
R&DCentrifugal microfluidic disc architecture allowing simultaneous processing of 14 key metabolic assays per run.
EtherX Lipid Profile Disc
ConceptHigh-throughput centrifugal disc dedicated to complete lipid fractionation and cardiovascular risk assessment.
Vital+Gas Sensor Array
PilotThick-film multi-sensor array cartridge capable of executing 10 critical parameters from a single 80µL arterial blood drop.
OmniSense Respiratory Panel
ConceptFully self-contained qRT-PCR cartridge utilizing dried down primer/probe mixes for differentiating up to 8 respiratory pathogens.
Microbiology AST-ID Panel
ConceptRapid antimicrobial susceptibility testing and identification mapping cartridge.
EtherX Reagent Magazine
R&DMulti-chamber reagent delivery module for automated loading into the EtherX system.
Capillary Collection Tube (LH)
Pilot100µL capillary tube pre-coated with Lithium Heparin. Designed for the Dr. POCT interface.
Serum Separation Tube (SST / Gel)
Prototype5mL evacuated tube with inert polymer gel for pristine serum extraction, optimized for EtherX robotic handling.
Precision Tips 200µL Filtered
PlannedPremium sterile filtered tips engineered for liquid handlers to prevent aerosol contamination.
Robotic Grip Tips 1000µL
ConceptHigh-volume tips with reinforced mounting collars for high-speed Z-axis gantry acceleration.
Arterial Blood Gas Syringe 3mL
PilotDry-lithium heparinized syringe with vented plunger specifically calibrated for the Vital+Gas Console intake port.
OptiClear Pathology Slides
R&DUltra-flat borosilicate glass with proprietary hydrophilic coating to minimize tissue folding before TissueScanner operation.
Magnetic Bead Extraction Array
Concept96-well format deep plate pre-loaded with silica-coated superparamagnetic beads for nucleic acid extraction.
Eco-PPE Isolation Gown
ConceptBio-polymer concept isolation gown designed to minimize petroleum-based waste in high-turnover clinical settings.
Eco-PPE Procedural Mask
ConceptBreathable, high-filtration mask utilizing compostable microfiber layers. Exploration prototype.
Build Together.
Use the AI Agent to explore hardware combinations, carrier mappings, and LIMS integration concepts. Or open an RFQ for R&D collaboration discussion.
R&D information only · No clinical claims · No medical advice
