Research Use Only. Not for use in diagnostic procedures. A concept for discussion, not a product offer.
Integration concept · Roche core lab

Integration concept

The blood-film read, inside the core-lab hematology workflow

Hemalogic reads the cell gallery a digital-morphology analyser already exports and returns a verdict, findings, an impression and a confidence for each call. This page sketches how that read could reach laboratories through Roche's lab IT and algorithm platforms.

Where Hemalogic sits

Analysers count the cells and digital morphology photographs them. The read of the film, deciding whether it is normal and what the pattern suggests, is still done by a person. Hemalogic adds that read between the analyser's export and the laboratory's validation rules.

1 · Analysers
Hematology analyserCBC, differential and flags, for example the Sysmex XN series
Digital morphologyCell gallery and red-cell overview, for example the Sysmex DI-60 or CellaVision DM
2 · Hemalogic read
Gallery readEvery cell and the film as a whole, in US-region cloud compute
Structured resultPositive or Negative, findings, impression, confidence, urgent flag
3 · Roche lab IT
navify Algorithm SuiteThe read offered as a partner algorithm, called by cloud API or HL7 v2
navify Lab OperationsThe verdict feeds validation rules: hold Positives for review, release under the lab's criteria
4 · Laboratory systems
Technologist reviewOpens the flagged slides first, corrects and signs
LIS and EHRSigned result by HL7 v2, under the lab's own order and specimen identifiers

One sample, start to finish

The bench does not change. The difference is that every gallery is read before a technologist opens it, and the slides that need an expert come first.

  1. The CBC flags a sample for film reviewHematology analyser and the lab's review criteria
  2. A slide is made, stained and imagedDigital-morphology analyser exports the cell gallery
  3. Hemalogic reads the galleryVerdict, findings, impression and confidence in 15–30 s at steady state
  4. The result enters the lab's middleware rulesA Positive holds the result for review; a Negative follows the lab's release criteria
  5. The technologist reviews the flagged slides firstCell-by-cell corrections, password-verified sign-off, full audit trail
  6. The signed result goes to the LISHL7 v2 under the lab's own identifiers; the LIS issues the patient report

Three routes into the Roche ecosystem

Each route uses an integration pattern Roche already runs. They can be taken one after another.

Route A · first

Partner algorithm in navify Algorithm Suite

The Suite already offers partner algorithms built on laboratory results, with cloud, hybrid and HL7 v2 connections.

  • Hemalogic hosted in its own US-region cloud, invoked through the Suite
  • Hemalogic remains the legal manufacturer of its algorithm
  • Would be the first algorithm in the Suite that reads the blood film itself
Route B

Verdict into navify Lab Operations

The middleware already runs range, delta and reflex checks on hematology results.

  • Hemalogic's verdict and findings arrive as a structured result
  • Lab-defined rules hold Positives and route them to review
  • Feeds the laboratory's own autoverification policy
Route C · later

The image-AI model of navify Digital Pathology

Third-party image AI already runs inside navify Digital Pathology.

  • The same model, applied to hematology galleries
  • The technologist reviews cell images inside the Roche environment
  • A path to Europe and other markets with Roche's quality system

What the laboratory gets

LevelWhat the report says
TriagePositive or Negative against the lab's own action criteria
FindingsBlasts, left shift, hypersegmented neutrophils, parasites, smear-quality exceptions
ImpressionThe pattern the findings fit, with alternatives; optional, never a diagnosis

Reports to date include acute leukaemia, chronic myeloid leukaemia, CLL and other lymphoid neoplasms, megaloblastic change, sickle cell disease and malaria.

How data is handled

  • All connections start inside the laboratory over outbound HTTPS; no inbound ports or VPN
  • Processing in US cloud regions, encrypted in transit and at rest
  • Each slide travels under a label with no patient identifier; the link to the accession number stays in the lab
  • Password-verified sign-off and a full audit trail on every slide
  • HIPAA business associate agreements with each laboratory and across subprocessors, for clinical use
  • SAML or OIDC single sign-on, SOC 2 Type II and an independent penetration test
In placePlanned

Regulatory status

Hemalogic is labelled Research Use Only. The US route starts with a 510(k) for a findings-level aid under 21 CFR 864.5260, followed by a De Novo request for autonomous release of negative slides, both supported by one multi-site US clinical study.

See a live read

A 30-minute call with a live read of de-identified slides, then a confidential review of the validation detail.

Contact James White