Volumetryx Inc. is a privately held oncology imaging CRO founded and led by a radiologist-driven team comprising CEO and Co-founder Vlad Cherniavsky, CMO and Co-founder Kateryna Musaieva MD, VP Oncology Imaging and Co-founder Burkhan Musaiev MD, and Co-founder Ilya Kalyzhniuk. The company was established to address a recognised gap in the imaging CRO market: the absence of a compliant, affordable, and rapid oncology imaging solution purpose-built for early-phase clinical trials, where the dominant imaging CRO providers are structured primarily for large, late-phase Phase III programmes and price their services accordingly.

The company’s commercial model combines a SaaS-delivered imaging data management platform — BioSUITE — with fee-for-service central read and advanced image analysis services, enabling it to serve sponsors across the full early-phase imaging workflow from a single integrated system. Its compliance framework is aligned with FDA 21 CFR Part 11, HIPAA, GDPR, and PIPEDA, supporting regulated clinical trial imaging across North American and European markets.

Volumetryx competes directly against traditional imaging CROs — which it positions as rigid, expensive, and optimised for Phase III — and against informal DIY imaging approaches, which lack structured QA and regulatory compliance. The company’s stated setup time of days rather than the three-to-six months typical of larger imaging CROs, combined with a 24–72 hour central read turnaround versus the one-to-four weeks of traditional providers, are its primary operational differentiators. Pricing is transparent and publicly available on its website, with a stated design principle of accessibility for early-stage biotech sponsors.

Key Products and Services

BioSUITE — Collect & Hold Platform

• Cloud-based SaaS DICOM imaging data management platform for oncology clinical trials, live from day one of trial activation
• Automated QA/QC at point of DICOM upload, flagging non-conforming images in real time before they enter the trial database
• Real-time site performance dashboard accessible to sponsor and CRO project teams, with mobile app access — stated as the first mobile app in the imaging CRO market
• Full DICOM data ownership for the sponsor — data viewable and exportable at any time, with no lock-in or pay-to-export restrictions
• FDA 21 CFR Part 11, HIPAA, GDPR, and PIPEDA compliant; hosted on AWS

Advanced Image Analysis

• Quantitative volumetric tumour analysis including metabolic tumour volume (MTV), total lesion glycolysis (TLG), viable tumour volume, and three-dimensional tumour segmentation
• Imaging biomarker generation providing quantitative, defensible go/no-go decision data for early-phase programme assessments
• Waterfall chart generation and per-subject response data export; full raw data access available to the sponsor team
• Turnaround within weeks from study activation

Central Read

• Blinded, standardised central image evaluation by oncology subspecialist radiologists with 24–72 hour standard turnaround
• Integration directly within BioSUITE — no separate data transfer step required
• Supported response criteria: RECIST 1.1, iRECIST, mRECIST, Lugano 2025, LYRIC, RANO 2.0, RECIP 1.0, PCWG3, and others
• Electronic CRF (eCRF) output with PDF report generation; spider chart and individual subject response tracking within the dashboard

Therapeutic Area Coverage

• Lymphoma — PET/CT-driven response assessment using Lugano and LYRIC criteria; MTV and TLG quantification; SUVmax and SUVpeak analysis
• GBM and Neuro-Oncology — MRI volumetry with RANO 2.0 criteria; viable tumour volume analysis; post-treatment change versus true progression assessment
• Solid Tumours — CT/MRI-based tumour measurement across RECIST 1.1, iRECIST, and mRECIST criteria
• Prostate Cancer — PSMA PET/CT with molecular tumour volume quantification and RECIP 1.0 response criteria

Volumetryx occupies a clearly targeted and operationally well-differentiated position in the oncology imaging CRO market, addressing a structural mismatch between the needs of early-phase sponsors — who require rapid, compliant, cost-accessible imaging services — and the dominant imaging CRO vendors, whose infrastructure, pricing, and timelines are calibrated for late-phase pivotal programmes. The 24–72 hour central read turnaround and same-week platform activation are materially significant for Phase I and Phase II programmes, where imaging data informs real-time dose escalation, patient selection, and go/no-go decisions that cannot wait weeks for a traditional imaging CRO workflow to complete. The founding team’s clinical radiology credentials — with oncology subspeciality expertise embedded at the co-founder level — provide scientific credibility that distinguishes Volumetryx from imaging technology platforms built primarily by software engineers without imaging clinical expertise. Transparent public pricing is an unusual feature in the imaging CRO market, where pricing is typically opaque and negotiated, and signals a deliberate positioning to remove the proposal-to-contract friction that disadvantages early-stage biotechs operating under capital constraints.