Execution and traceability for regulated diagnostics

A diagnostic result is only as good as the chain that delivers it

DxTrace carries a result from your reader to your customer's EHR — authenticated, sealed, and traceable to the exact algorithm, calibration and environment that produced it.

Between your instrument and your customer's chart, a result crosses several trust boundaries. Each one is a place it can be altered, misattributed — or simply become impossible to defend later. DxTrace runs your algorithm in a sealed, deterministic environment and gives every result a record that survives the question "how was this produced?"

Your expertise lies in chemistry, microfluidics, assays, biology — and maybe you know a third-party reader or two. You shouldn't have to worry about the rest of the stock technology pipeline that takes your science into a clinician's office in a secure and compliant manner. Let DxTrace set those rails up for you.

Handheld cassette reader with a lateral-flow cassette inserted
01Your Assay
02Your Device
03Your Reports
04Your Data
Our Rails

The principle

Your test, our rails.

You keep the science, the device and the customer; we take responsibility for carrying the result and proving how it was produced.

Reader in the lab
DxTrace cloud
Signed test report
Physician's office

The path a result takes

A traceability record accumulates at every step

AT THE SITEDXTRACE RAILS AND RUNTIMETO YOUR CUSTOMER
01
Authenticate
CERTIFICATE PER DEVICE
02
Corroborate
KNOWN DEVICE, SITE, SPECIMEN
03
Execute
PINNED DIGEST, NO EGRESS
04
Release
VERSION-LOCKED TEMPLATE
05
Deliver
ACKNOWLEDGED, OR ESCALATED

YOUR ASSAY

The chemistry stays yours.

The cassette, the analytical validation and the clinical claim. We do not touch any of it.

YOUR DEVICE

The reader stays yours.

We authenticate it and register it to a site. We never ask you to change it or its firmware.

YOUR REPORTS

Your algorithm, your output.

Delivered to us in a signed container, built and versioned inside your quality system.

YOUR DATA

Yours to export.

You own everything your system generates, available for export and download under controlled access.

We execute. A sealed, deterministic runtime and a traceability record for every result. That is our entire scope — and we are accountable for all of it.

See the mechanism, or start the conversation.