Community pharmacy partner overview

LotusDx gives community pharmacies a private 20-minute chlamydia self-test without requiring the branch to run the diagnostic or build a new STI service.

Women self-test at home using a self-collected vulvovaginal swab. LotusDx manages the result, clinical pathway, data and follow-up through a central digital service. Pharmacies choose whether to retail only, dispense treatment, or provide the independent prescriber consultation.

Women’s clinical validation target: 2028 Planned route: IVDR Class C self-test GB: MHRA registration before market placement Reusable reader + single-use cartridge

The pharmacy can keep its role simple. Retail-only pharmacies do not need to operate the test, perform diagnostic quality control or manage STI results. Pharmacies that want more involvement can add dispensing or an independent prescriber consultation.

Pharmacy pathway

LotusDx can be introduced at the natural moments when patients already ask about sexual health, pregnancy, contraception or testing.

Walk-in testing requestA patient asks directly for an STI test, reassurance after exposure or a private option outside a postal pathway.

Emergency contraceptionUnprotected sex or condom failure creates a clear moment to discuss testing, timing and the wider sexual-health pathway.

Contraception consultationNew-partner discussions, routine contraception reviews and broader sexual-health conversations can prompt a testing offer.

Pregnancy test requestPregnancy-related discussions can also surface exposure concerns, new relationships or a wish for STI reassurance.

Symptoms or sexual-health adviceDischarge, dysuria, pelvic concerns or general STI questions can trigger testing, referral or a more appropriate clinical route.

Other related enquiriesCondom purchases, UTI, thrush or BV queries and general walk-ins can open a brief testing conversation where relevant.

The branch workflow can start at the counter or in the consultation room.

Staff identify a relevant trigger moment and introduce LotusDx as a private at-home testing option.
The patient can buy the test immediately, or the conversation can move into the consultation room when privacy or additional discussion is needed.
The patient activates the test through the LotusDx app or web portal using a QR code or manual code entry.
From activation onward, LotusDx manages eligibility, instructions, results and follow-up through the central digital patient pathway, so the branch does not need to run or interpret the diagnostic.

Clinical evidence plan

The initial launch is for women, with clinical validation against a laboratory PCR targeted for 2028.

The planned study compares LotusDx with Roche cobas® CT/NG real-time PCR on the cobas® 6800/8800 using paired self-collected vulvovaginal swabs from symptomatic and asymptomatic women.

≥95%Sensitivity / PPA target95% CI lower bound ≥90%

≥99%Specificity / NPA target95% CI lower bound ≥98%

≤2%First-attempt invalid targetUntrained users at home

≤20 minResult-time targetPositive / negative / invalid

2028Women’s validation targetInitial intended-use population

Prospective clinical-performance study

Initial populationSymptomatic and asymptomatic women, 18–34

LotusDx specimenSelf-collected vulvovaginal swab

ComparatorRoche cobas® CT/NG real-time PCR, cobas® 6800/8800

DesignProspective, blinded, multicentre, paired comparator testing

Statistical endpoint≥200 CT-positive + ≥1,800 CT-negative comparator results

Primary outputsPPA, NPA, 95% CIs, invalids, subgroup and discordant analysis

Planned regulatory route

Planned intended-use claimQualitative at-home detection of Chlamydia trachomatis from a self-collected vulvovaginal swab in symptomatic and asymptomatic women aged 18–34.

EU IVDR Class C self-testConformity assessment is planned for the final home-use claim and instructions for use.

Great BritainMHRA registration will be completed before the device is placed on the GB market.

Home-use evidence

At home, women will be able to complete the test and move from any result to a clear next step without needing the pharmacy to troubleshoot the process.

Planned lay-user study

Participants≥300 untrained women

SettingUnsupervised home use

RepresentationAge, education, literacy and digital-literacy range

Instructions for use (IFU)Illustrated printed IFU in every box, mirrored step-by-step in the LotusDx app / web portal

Critical tasksCollect, load, run, read and act on the result

Human factorsErrors, near-misses, comprehension and recovery

≥95%unassisted critical-task completion

≥99%result-interpretation agreement

≥95%correct next-step comprehension

≤2%first-attempt invalid rate

Every result leads to a defined action. If the test is invalid, the patient is told not to rely on it, receives a free replacement, and is guided through a repeat test. Repeated invalids are escalated to LotusDx support and, where needed, an alternative laboratory test or sexual-health service.

Analytical evidenceLimit of detection, inclusivity, cross-reactivity, interference, precision and stability.

Usability evidenceIEC 62366-1 formative and summative human-factors work for unsupervised use.

Clinical evidenceProspective women’s vulvovaginal-swab study compared with laboratory PCR.

After launchInvalids, complaints, false-result signals, corrective action and performance follow-up.

Patient pathway

Every patient is guided through the LotusDx digital platform from activation to a clear result, treatment, repeat testing or referral.

Buy and activate digitallyScan the pack QR code or enter the code manually in the free LotusDx app / web portal. Browser access is available without downloading the app.

Digital eligibility checkThe platform captures consent, identity, symptoms, exposure timing and exclusions before testing.

Follow the IFU and test at homeThe box includes an illustrated IFU, with the same guided steps in the LotusDx app / web portal. The patient self-collects the swab, runs the test and receives a positive, negative or invalid result.

Every result has a clear next stepPositive results move to clinical review, negative results receive timing and follow-up advice, and invalid results trigger a free replacement and guided repeat-test pathway.

Care stays connectedThe same digital pathway supports treatment where appropriate, partner information, retesting reminders and referral when needed.

The LotusDx app / web portal keeps activation, instructions, results and follow-up in one patient pathway

Digital activation, consent and clinical intake
Exposure timing and exclusion logic
Positive-result review and prescribing fallback
Invalid-result guidance, free replacement and repeat-test support
Partner information and retest reminders
Device complaints, vigilance and post-market follow-up

A retail-only pharmacy does not need to run the clinical workflow

No branch assay operation
No diagnostic quality control
No result interpretation
No independent prescriber required to retail the product
No STI result shared unless the patient chooses a pharmacy dispensing or clinical route

Pharmacy participation

Pharmacies can retail the test only, add medicine dispensing, or provide the independent prescriber consultation.

1 · Retail only

Product margin with minimal workload

LotusDx manages the patient journey after purchase.

Retail and recommend the product
No branch testing or result handling
No independent prescriber required

2 · Retail + dispensing

Keep medicine fulfilment without taking on prescribing

LotusDx provides the clinical pathway and independent prescriber review for eligible positive cases.

Retail and recommend LotusDx
Eligible prescriptions can route to the pharmacy
No diagnostic quality control or positive-result triage

3 · Independent prescriber consultation

Keep the consultation and prescribing episode

For pharmacies that want to provide their own private clinical service.

Authenticated result routes back to the pharmacy
Your independent prescriber conducts the consultation and makes the prescribing decision
Your pharmacy retains the clinical-service revenue

RetailProduct gross margin

DispensingMedicine fulfilment where applicable

Clinical serviceOptional consultation and prescribing fee

LotusDx is a private option alongside existing NHS, council and private testing pathways.It gives pharmacies an additional route for patients who want a rapid at-home result, are outside a local eligibility pathway, or prefer not to use a postal service.

Data, cybersecurity and clinical governance

The service is designed so retail-only pharmacies do not receive STI results, while LotusDx manages the data, cybersecurity and device governance for the central pathway.

Data roles are explicitLotusDx controls the self-test app / web portal and central digital care pathway; pharmacies control only the dispensing or clinical records they actually create.

Special-category data is minimisedUK GDPR / DPA 2018 lawful-basis documentation, privacy information, retention schedule, data-subject request process and data-sharing agreements.

A DPIA precedes launchHealth-data processing, identity, result handling and clinical decision support are assessed before processing begins.

Access is role-basedMulti-factor authentication for clinical users, least privilege, audit logging and separation between retail and clinical workflows.

Security is engineered inEncrypted data in transit and at rest, vulnerability management, penetration testing, backups and incident response.

Device failures remain traceableLot, cartridge and reader traceability support complaint investigation, vigilance, corrective action and field safety action.

ISO 13485Quality-management system

ISO 14971Medical-device risk management

IEC 62366-1Lay-user usability engineering

IEC 62304Medical-device software lifecycle

IEC 81001-5-1Health-software cybersecurity lifecycle

ISO 27001Information-security management target

Cyber Essentials PlusIndependent cyber-control verification target

UK post-market surveillanceComplaints, trends, incidents and corrective action

Commercial model

The starter pack gives £14.99 gross profit and the two-test refill £9.99, with no setup fee or mandatory consultation.

Starter pack

Reader + 1 chlamydia cartridge

Everything a new patient needs for one at-home test.

Wholesale£25.00

Recommended RRP£39.99

Gross profit£14.99

Gross margin37.5%

Refill pack

2 chlamydia cartridges

For patients who already own the reusable LotusDx reader.

Wholesale£15.00

Recommended RRP£24.99

Gross profit£9.99

Gross margin40.0%

≥18 moShelf life on delivery

12 unitsMixed opening order

£0Branch setup fee

15 minOptional team briefing

IncludedInvalid-test replacement

2 yearsReader warranty

Pilot diligence

Before any pharmacy pilot, the superintendent receives the regulatory, clinical, governance and commercial evidence needed to assess the service.

Regulatory routeIVDR Class C self-test plan, intended use, conformity-assessment strategy and GB registration plan

Clinical protocolWomen’s study protocol, comparator, statistical-analysis plan, acceptance criteria and 2028 validation timeline

Analytical packageLimit of detection, precision, inclusivity, cross-reactivity, interference, stability and environmental robustness

Home-use evidencePrinted and digital IFU, IEC 62366-1 usability work, critical-task study, result interpretation and next-step comprehension

Clinical pathwayEligibility, exclusions, positive-result review, prescribing, referral, partner information and retesting

Data protectionDPIA, privacy notice, controller map, retention schedule and data-sharing / processor agreements

CybersecurityAccess-control model, penetration-test summary, vulnerability management and incident response

Post-marketComplaint handling, lot traceability, performance follow-up, corrective action, recall and replacement process

CommercialPrice list, opening order, shelf-life commitment, returns, warranty, margin and pilot terms

2027Analytical verification, integrated device verification and formative home-use work.

2028Women’s clinical validation, final home-use evidence and initial self-test launch target.

Regulatory routeEU IVDR Class C self-test conformity assessment, with MHRA registration completed before GB market placement.