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Malaria diagnostics · research stage

Counting parasites is the hard part.

Detecting malaria on a blood film is close to solved. Reporting how many parasites are there — the number that decides whether a case is severe — is not. MalariaX is building GPU-accelerated blood-film analysis that treats parasite density as the primary output.

282M
Malaria cases worldwide in 2024, up from 273M in 20231
610,000
Deaths in 2024. Eleven countries carry about two-thirds of the burden1
47.3%
Specificity of routine microscopy against expert re-reading, Dar es Salaam2
23%
Share of an AI microscope’s density estimates within ±25% of reference3
The problem

Routine microscopy reports far more malaria than is actually there.

53%reported positive

When researchers re-read 335 slides from eleven public health facilities in Dar es Salaam, the laboratories had reported 53.1% of them as positive. Expert microscopists confirmed 2.1%.2

Sensitivity was 71.4% and specificity 47.3%, giving a positive predictive value of 2.8%. Ninety-three percent of the positive reports were recorded at the lowest possible density, one to five parasites per 200 white cells. Median reported density was 3 parasites per 200 WBC; expert median on genuinely positive slides was 1,226.

Detection is not the bottleneck any more

Machine-learning microscopes already match trained readers at finding parasites on a clean slide. The 2018–19 multi-country evaluation of EasyScan GO across eleven countries and 2,250 slides reached 91.1% sensitivity and 75.6% specificity against expert reference.3

Quantification still is

In that same study only 196 of 845 slides — 23% — produced a density estimate within ±25% of the reference count, and sensitivity fell to 57.1% below 200 parasites/µL. The device was graded WHO–TDR competence level 2 for detection but level 4 for quantification.3

Published performance against expert reference microscopy
MeasureRoutine lab microscopyEasyScan GO (ML device)What MalariaX targets
Sensitivity71.4%95% CI 35.9–91.891.1%95% CI 88.9–92.7≥ expert level 1
Specificity47.3%95% CI 41.9–52.775.6%85.1% on high-quality slides≥ 90%
Sensitivity below 200 p/µLnot reported57.1%the primary research question
Density within ±25% of referencenot reported23%196 of 845 slidesthe product
Study size335 slides, 11 facilities2,250 slides, 11 countriesstage 1, see below

That last row is the whole thesis. A binary answer can be produced by a rapid diagnostic test for a fraction of the cost. The reason to put a slide under a microscope at all is the number, and the number is what everyone is currently getting wrong.

MalariaX Vision

What happens to a slide

The system sits on top of the microscope a laboratory already owns. No proprietary hardware, no change to staining protocol, and a qualified reader signs every result.

01

Prepare and stain

Laboratory · unchanged

Thick and thin films, Giemsa, exactly as the lab does today. We deliberately did not design around a proprietary consumable.

02

Scan fields

Camera adapter

A camera on the existing 100× oil objective captures a defined number of fields. Field count is recorded because density arithmetic depends on it.

03

Reject bad images before analysing them

Quality gate

Blur, uneven illumination, stain precipitate and empty fields are caught here and the operator is asked to recapture. Silently analysing a bad film is how false positives are manufactured.

04

Detect and localise

GPU inference

A detector proposes parasite locations with a confidence score for each. Every proposal keeps its coordinates so a human can go back and look at it.

05

Count the denominator

GPU inference

Density is a ratio. A second model counts white cells on the thick film or red cells on the thin film, so parasites/µL is computed rather than estimated by eye.

06

A human decides

Qualified reader · required

The reader sees every detection overlaid on the original field, with confidence and an interval on the density. They confirm, correct or reject. The system does not issue a result on its own.

07

Sign and export

Laboratory

A signed record with species, density, field count and the reader’s identity. Corrections are retained separately and only enter training data under an explicit agreement.

Why this is difficult

Real slides look nothing like a benchmark

Stain varies by bench

Giemsa pH, buffer age and staining time differ between labs and between technicians in the same lab. Colour shifts that a human ignores will move a model’s decision boundary.

Debris resembles parasites

Platelets over red cells, stain precipitate, bacteria and Howell-Jolly bodies all produce chromatin-like dots. This is the dominant source of false positives in both human and machine reading.

Density spans five orders of magnitude

From under 50 parasites/µL to over 500,000. A model tuned for the middle of that range fails at the two ends that matter clinically.

Optics are not standardised

Objective quality, condenser alignment, camera sensor and colour processing all differ. A model trained on one rig frequently does not transfer to another.

Species matters for treatment

Distinguishing P. falciparum from P. vivax, ovale and malariae changes what a clinician prescribes. Published external quality assessment in West Amhara found species misdiagnosis on 5.4% of slides — the single largest discordance category.4

The ground truth is itself imperfect

Expert reference counts vary between readers. WHO competency assessments grade microscopists on a four-level scale for exactly this reason, and pass rates for level 1 are frequently below half the cohort.5

Connectivity is intermittent

Many target sites have unreliable bandwidth. Whole-slide images are large, so the split between local and remote processing is a design constraint, not a deployment detail.

Architecture

Where data goes, and where it stops

Two things in this diagram are deliberate: the quality gate can send work back before any model runs, and nothing reaches a patient record without passing through a person.

MalariaX Vision data flow Two capture sources feed a capture application, then an image quality gate which either returns the slide for recapture or passes it to two parallel models: a parasite detector and a cell counter. Their outputs combine into a density estimate with uncertainty, which goes to a human reviewer console. The reviewer output fans out to a signed patient report, the laboratory record system, and a governed training corpus. Digital microscope Existing scope + camera adapter Capture app Image quality gate Recapture requested Parasite detector Cell counter denominator Density estimate with uncertainty Reviewer console qualified reader signs off Signed report species + density Laboratory record LIS export Training corpus only under agreement
analysis path conditional / governed path human sign-off required before release
Compute

What we actually run on

Listed honestly: some of this is in daily use, some is on the plan for when there is production traffic to justify it. Items marked planned are not in use today.

NVIDIA

CUDA
The training and image-processing substrate. Everything in the detection and counting pipeline is written against it.
cuDNN / PyTorch
Model development for the detector and the cell counter, on A10G and L4 class GPUs.
DALI
Whole-slide tiles are large and the input pipeline, not the GPU, is usually the bottleneck. Decoding and augmentation move onto the device.
TensorRT planned
Inference optimisation once model architecture is frozen. Premature to do this while the detector is still changing weekly.
Jetson Orin planned
On-site inference for laboratories where uploading whole-slide images is not realistic. Depends on pilot connectivity data we do not have yet.

AWS

S3
Image and annotation storage, versioned, with object-level access logging. Region choice follows the data-residency terms of each source agreement.
EC2 G5 / G6
Spot instances for training runs. Cost discipline matters more than throughput at this stage.
SageMaker
Experiment tracking and evaluation jobs, so that every reported metric maps back to a specific commit and dataset split.
IAM / CloudTrail
Least-privilege roles and an audit trail. A requirement of the data agreements, not an aspiration.
ECR + ECS planned
Reproducible inference containers, once there is an external user to serve.
Validation

Four stages. We are on the first one.

Nothing below is a claim about performance. It is the sequence we intend to follow, and marking our position on it honestly is more useful to a prospective partner than a number we cannot defend.

Stage 1 · current

Data and annotation

  • Public datasets for baselines
  • Annotation protocol with a parasitologist
  • Inter-annotator agreement measured before any model claim
  • Seeking slide sets from partner labs
Stage 2

Retrospective evaluation

  • Held-out sets by site, not random split
  • Density agreement as the headline metric
  • Performance reported per density band
Stage 3

Multi-site robustness

  • Different stains, scopes and cameras
  • Between-site variance reported openly
  • Failure cases published, not filtered
Stage 4

Prospective study

  • Alongside routine workflow, not replacing it
  • Pre-registered protocol
  • Regulatory pathway confirmed per jurisdiction

What we train and test on

Public malaria microscopy data is small, narrow and mostly P. falciparum. Being specific about that is part of the point.

Public datasets currently in use
DatasetContentsKnown limitation for our purpose
NIH / NLM thin smear627,558 segmented cells13,779 parasitised, 13,779 cleanPre-segmented single cells from 150 P. falciparum patients in Bangladesh. Useful for classification, useless for density, since the field context is gone.
BBBC04171,328 images~80,000 cellsWhole fields with expert annotations, which is what density work needs. Small, and single-source.
MP-IDB84 speciesfalciparum, vivax, ovale, malariaeThe only public set with meaningful non-falciparum representation. Too small to train species classification on alone.

None of these were collected on the equipment our target laboratories use, and none carry thick-film density references. Closing that gap is the reason the pilot programme exists, and it is the main thing we need from partners.

Safety and oversight

Where the model is not allowed to decide

A person signs, always

No result leaves the system without a qualified reader confirming it. This is a hard constraint in the software, not a workflow recommendation. If a laboratory wants an unattended mode, we are not the right supplier.

Uncertainty is shown, not smoothed

Low-confidence detections and wide density intervals are surfaced prominently. A system that hides its doubt trains its users to stop checking, which is the failure mode that makes assistive AI dangerous.

Performance is reported by subgroup

Aggregate accuracy hides the cases that matter. Metrics are broken out by density band, species, stain quality and site. If the system is worse at low parasitaemia, that belongs in the report, not the appendix.

Corrections stay separate from training data

Reader corrections are stored and can be audited, but they only enter a training set under an explicit data agreement with the institution. Silent learning from clinical use is not something we do.

Research performance is not clinical performance

Until a prospective study is complete and the relevant regulator has been engaged, any number we publish is a research finding. We will say so every time, including when it is inconvenient.

What comes after

Vision first, and for a long time

Three further products are on the plan. They depend entirely on the first one working and on having governed data from real deployments, so what follows is a statement of intent, with no dates attached.

Next

Forecast

Transmission-risk estimates from verified diagnostic counts combined with rainfall, temperature and land use. Needs a deployed base of sites reporting density before it means anything.

Research

Genome

Drug-resistance marker surveillance. This requires sequencing partners and an ethics framework we do not have, and it is a research collaboration rather than a product.

Later

Command

A programme-level view for ministries and malaria control programmes, aggregating across sites. Only meaningful once enough laboratories are running Vision to make the aggregate representative.

Market and model

Sell to laboratories, not to health systems

Ministry procurement cycles are long and evidence-hungry, and rightly so. Private diagnostic laboratories and research groups can adopt on a shorter timescale, and they are the ones who feel the cost of a re-read.

First

Private diagnostic laboratories

High slide volume, direct cost pressure, no procurement committee.

Research groups and trials

Need defensible, auditable density counts and already work to a protocol.

Teaching hospital laboratories

Have the reference expertise to validate against, and an interest in training.

Only after evidence

National malaria control programmes

Require prospective data and a regulatory position before any serious conversation.

Hospital and laboratory groups

Multi-site licensing, once single-site deployment is proven and supportable.

Global health organisations

Surveillance value only exists at a coverage level we are nowhere near.

How it would be paid for

Per-site subscription banded by slide volume, with a research tier priced at cost for validation partners. We have not tested willingness to pay, so treat these as hypotheses. Anyone who quotes you a confident price for a product with no clinical data is selling you something else.

Team

The people building it

Computer vision, laboratory parasitology, and the engineering that sits between them.

Founder

Mark Kieni

Data partnerships, pilot recruitment and fundraising. Most of the job is getting slide sets released to us.

Engineering

Sharon Akoth

Builds the detection and counting models, and the training pipeline they run on. Owns the path from image intake through to a density estimate.

Clinical parasitologist

Henry Korben

Reference reader. Sets the annotation protocol, and adjudicates every disagreement between the model and a slide.

Contact

Tell us which conversation this is

Pilot sites and parasitologists get answered first, because that is what we are short of. Everything else within a few working days.

No patient data in this form, please. If you need to share slides or records, say so and we will set up a proper agreement first.

Pilot sites and laboratories

Slide sets, protocol questions, or hosting an evaluation.

pilots@malariax.com

Research and data sharing

Annotation protocols, dataset access, co-authorship.

research@malariax.com

Investors

Stage, plan and what the money would be spent on.

investors@malariax.com

Everything else

Press, speaking, or none of the above.

hello@malariax.com
Response
Two working days, usually sooner for pilot enquiries
Follow
Questions

Including the awkward ones

No. We are at stage 1: assembling data and fixing the annotation protocol. Every performance figure on this site is from published work by other groups and is cited. When we have our own numbers we will publish the protocol and the failure cases with them.

For a yes-or-no answer you should. RDTs are cheaper, faster and do not need a trained reader. Microscopy exists because it gives species and parasite density, which RDTs do not, and density is what determines whether a case is treated as severe. That is the part we are working on.

Detection largely is. The 2022 multi-country evaluation reached 91.1% sensitivity, which is genuinely good. Quantification is not: 23% of density estimates landed within ±25% of the reference count, and the device was graded WHO–TDR level 4 on quantification accuracy. It also requires buying their scanner. We are targeting the quantification gap on hardware laboratories already own.

No, and the software will not let you. A qualified reader has to sign every result. Where microscopists are scarce the useful thing is to make each one faster and more consistent, not to remove them from a decision that carries clinical risk.

None. We have not applied. The intended-use statement has to be settled first, and it determines which pathway applies and in which country. Hiring an advisor for this is on the list above.

Annotated slide sets from laboratories in endemic settings, with thick-film density references, and a parasitologist willing to act as reference reader. Funding matters, but data is the binding constraint.

Sources

Every figure on this page

1. World Health Organization. World malaria report 2025, published 4 December 2025. 282 million cases and 610,000 deaths estimated for 2024 across 80 endemic countries. who.int

2. Kahama-Maro J, D’Acremont V, Mtasiwa D, Genton B, Lengeler C. Low quality of routine microscopy for malaria at different levels of the health system in Dar es Salaam. Malaria Journal 2011;10:332. PMC3217957

3. Das D, Vongpromek R, Assawariyathipat T, et al. Field evaluation of the diagnostic performance of EasyScan GO: a digital malaria microscopy device based on machine-learning. Malaria Journal 2022;21:122. PMC9004086

4. Mitiku H, et al. External quality assessment of malaria microscopy diagnosis among public health facilities in West Amhara Region, Ethiopia. 6,689 slides cross-checked; 8.12% discordant, 5.4% species misdiagnosis. PMC5740603

5. Analysis of the WHO External Competency Assessment of Malaria Microscopists (ECAMM). Malaria Journal 2019;18:359. Competency graded on a four-level scale; level 1 certification rates commonly fall below half of each cohort. malariajournal.biomedcentral.com

6. Rajaraman S, Antani SK, Poostchi M, et al. Pre-trained convolutional neural networks as feature extractors toward improved malaria parasite detection in thin blood smear images. PeerJ 2018;6:e4568. Dataset of 27,558 segmented cell images. dataset catalogue

7. Broad Bioimage Benchmark Collection, BBBC041: malaria-infected human blood smears, 1,328 images. bbbc.broadinstitute.org/BBBC041

8. Loddo A, Di Ruberto C, Kocher M, Prod’Hom G. MP-IDB: The Malaria Parasite Image Database for Image Processing and Analysis. neuroimaging.it

If you read malaria films for a living, we would like to hear from you.

The gap between what a slide contains and what gets written on a report is where this project lives. We need laboratories willing to help measure it.