Here is the company profile for DNACHAIN:

DNACHAIN

One-Line Summary

DNACHAIN is a US-based software-as-a-service company providing a tamper-evident chain-of-custody tracking and dynamic consent governance platform purpose-built for genomics laboratories, biobanks, CROs, and clinical research institutions.

Company Description

DNACHAIN is a specialist clinical and genomics technology company offering a cloud-based SaaS platform designed to address a specific and increasingly regulated problem in life sciences: the integrity and auditability of biological sample tracking and donor consent management. The company is contactable via su*****@******in.bio and sa***@******in.bio, and positions its product for institutional procurement across genomics research, biobanking, and regulated clinical research environments.

The platform’s core technical architecture is built around cryptographic hash chaining — specifically SHA-256 — applied to every custody event recorded for a biological sample. This approach ensures that any post-hoc alteration to a record is immediately detectable, as it breaks the cryptographic chain and triggers automated integrity alerts. The resulting audit trail is independently verifiable and exportable as a cryptographically signed PDF, enabling direct submission to regulators or use in inspection-readiness documentation.

DNACHAIN’s compliance framework is designed to support HIPAA (with signed Business Associate Agreements available at enterprise tier), GDPR, and the regulatory requirements of genomics research and clinical trial sample management. The platform is available on a tiered subscription model ranging from a free pilot tier to an enterprise plan with custom pricing, dedicated account management, and SLA-backed uptime guarantees. Partnerships are listed with ORDEX Systems and BioTrace Compliance, indicating a broader ecosystem alignment with laboratory information and compliance tooling providers.

The company appears to be an early-stage venture, with no founding date, employee count, or investor information publicly disclosed on the website.

Key Products and Services

Tamper-Evident Chain-of-Custody Tracking

• SHA-256 cryptographic hash chaining applied to every custody event, creating an immutable, sequentially linked audit record for each biological sample from registration through to final disposition
• Any post-hoc edit to a record breaks the cryptographic chain and triggers instant integrity alerts to all administrators via email and in-app notification
• Real-time custody event feed with dual-signed transfer records and per-shipment manifests, logging every sample handoff with timestamp and cryptographic chaining at the point of transfer
• Continuous live re-hashing of records to detect and flag data drift as it occurs rather than at audit time

Dynamic Consent Engine

• Versioned, scope-aware consent records tracking the specific purposes for which donor consent has been granted, with full version history
• Automated consent expiry alerts notifying relevant staff ahead of consent lapse
• Database-enforced consent withdrawal cascade that automatically blocks new sample transfers linked to withdrawn consent, preventing inadvertent regulatory non-compliance
• Audit trail of all consent changes, versioning, and withdrawal events

Signed Audit Exports

• Regulator-ready PDF audit reports cryptographically signed against the full hash trail, independently verifiable in a single step
• Branded PDF export capability at enterprise tier for custom compliance reporting

API and Workflow Integration

• REST API with scoped API keys enabling integration of the DNACHAIN audit chain into existing laboratory workflows and data pipelines
• Webhooks for event-driven integration with external systems
• LIMS (Laboratory Information Management System) connectors allowing the platform to extend tamper-evident tracking into established laboratory infrastructure without requiring system replacement
• Bulk sample import via CSV upload for migration of existing sample registries at enterprise tier

Enterprise Compliance Features

• HIPAA BAA — signed Business Associate Agreement for covered entities and business associates
• SAML 2.0 / Okta / Azure AD single sign-on integration
• Custom data retention policies with configurable audit log retention periods
• 99.9% uptime SLA with financial penalties
• Annual security review with shared penetration test results
• 4-hour priority support response SLA

Subscription Tiers

• Free — 10 active samples, 2 users, full SHA-256 audit chain, basic consent tracking
• Starter (USD 199/month) — up to 500 samples, 5 seats, full consent engine
• Team (USD 399/month) — up to 2,000 samples, 10 seats, REST API access, automated consent expiry alerts
• Professional (USD 599/month) — up to 5,000 samples, 15 seats, LIMS integration support, scoped API keys, priority support
• Enterprise — custom pricing, BAA, dedicated account manager, SSO, custom compliance reporting

DNACHAIN addresses a compliance gap that has grown in significance alongside the rapid expansion of genomics research, multi-site biobanking, and cross-border sample transfer in clinical trials: the absence of an independently verifiable, tamper-evident record of sample custody and consent status. Existing LIMS and biobank management systems typically record custody and consent data without the cryptographic integrity layer that would allow that data to be independently verified or demonstrated to be unaltered — a limitation that becomes material during regulatory inspections, data access disputes, or consent withdrawal scenarios. DNACHAIN’s use of SHA-256 hash chaining is a well-established cryptographic technique borrowed from distributed ledger design, applied here without the overhead of a blockchain network, producing a lightweight, auditable integrity layer that can sit atop existing infrastructure via API rather than replacing it.