Counting EMPE Diagnostics' EIC Accelerator Results in TB Testing

EMPE Diagnostics, a Swedish company based at the Karolinska Institute Science Park in Solna, was selected in the EIC Accelerator pilot's October 2020 cut-off for mfloDx, a DNA test meant to show within three hours whether a tuberculosis patient carries drug-resistant bacteria. The European Commission's list of winners names it as a grant-only winner, with no partner company on the project. CORDIS records an EU contribution of €2,485,525 towards a total cost of €3,550,750, for a project that ran from 1 March 2021 to 29 February 2024.

The company did part of what it promised. Its first kit, mfloDx MDR-TB, was launched in Hyderabad in July 2023 with approval from India's Central Drugs Standard Control Organisation (CDSCO), according to BioSpectrum India, and the company's website refers to a "CDSCO-approved IVD product" made at its Hyderabad plant. Its broader test for pre-extensively drug-resistant TB (pre-XDR-TB), which the EIC project was meant to bring to market, was still being introduced "for Research Use Only" in September 2026, under a new brand, CircuLOK, according to a company press release.

Where EMPE Diagnostics Stands Now

EMPE Diagnostics AB is an active company in the Swedish register, with Jan Buch Andersen as external chief executive and Olle Wahlqvist as board chair, according to Ratsit and Hitta, which both draw on its filings. The board includes Mats Bo Johan Nilsson Bernitz; the CORDIS summary names a co-founder, Mats Nilsson, as the inventor of the padlock probe chemistry behind the test. Pavan Asalapuram, chief executive when the company applied to the EIC according to CORDIS, is not listed as board member or chief executive; when that changed could not be verified from the sources consulted. The group consists of the Swedish parent and an Indian subsidiary, EMPE Diagnostics Pvt Ltd, according to Hitta.

The latest public activity is the September 2026 announcement that EMPE would unveil three CircuLOK tests at India's national TB conference, NATCON 2026, in Patiala from 1 to 4 October: an MDR-TB test for rifampicin and isoniazid resistance, a pre-XDR-TB test adding fluoroquinolones, and a stand-alone fluoroquinolone test. The release says the products are made at the ISO 13485-certified Hyderabad facility and that EMPE is pursuing CDSCO approval and a performance evaluation with the Indian Council of Medical Research. The company's website describes CircuLOK MDR-TB as a "Trial version ready to ship to selected labs by Q4, 2026". The release does not mention mfloDx, and the website does not name the product that carries the CDSCO approval.

The Technology: Padlock Probes on a Test Strip

The test combines padlock probes, short DNA strands that close into a ring only when they meet an exact gene sequence, with rolling circle amplification, which copies that ring many times, and a lateral flow strip that shows the result as visible lines, "similar to a COVID-19 test", according to a study abstract indexed by DOAJ. The MDR-TB kit looks for the tuberculosis bacterium and for mutations in the rpoB and katG genes and the inhA promoter that cause resistance to rifampicin and isoniazid, the two main first-line drugs. A company flyer published by AMR Insights lists 15 targets for the MDR-TB kit and 23 for the pre-XDR-TB kit, with "only standard lab equipment" needed and three to five hours from sputum to result.

The established alternative is cartridge-based testing on dedicated machines. The CORDIS summary says commercial diagnostics often need equipment costing €12,000 to €70,000, and that fewer than one third of new TB patients were tested for drug resistance. EMPE's pitch is a test that a basic laboratory can run in batches without such instruments. The company flyer counts "7 simple steps" from sputum to result.

What the Clinical Studies Show

Two peer-reviewed evaluations exist, both on samples from a tertiary care centre in India and both co-authored by Pavan Asalapuram. In the first, published in the International Journal of Mycobacteriology in 2024, the MDR-TB kit was tested on 210 sputum samples. It detected tuberculosis with a sensitivity of 84.9% against culture, found rifampicin resistance with 100% sensitivity and isoniazid resistance with 84.6% sensitivity, and gave no false positives among 100 negative controls, according to the abstract on DOAJ. In smear-positive samples its sensitivity was 86.4% against Xpert MTB/RIF, the most widely used rapid molecular test.

The second study, in Frontiers in Tuberculosis in 2025, tested the pre-XDR-TB kit on 731 sputum samples. Resistance detection was strong: 98.2% sensitivity for rifampicin, 86.2% for isoniazid and 93.3% for fluoroquinolones, with specificities between 99.2% and 100%. Detection of the bacterium itself was weaker, at 86.2% sensitivity and 82.0% specificity against culture, which the authors said needed further work.

What the EIC Project Promised, and What the Record Shows

The 2021 CORDIS summary set out the plan: finish clinical validation, obtain in vitro diagnostic (IVD) certification "for an estimated launch in late 2022", set up large-scale production and reach the TB diagnostics market "with WHO backing". It said the company had raised about €2 million in seed capital, and that its Solna facility produced kits for research use only. EMPE had earlier received €50,000 for a four-month SME Instrument Phase 1 feasibility study on the Indian market, which ended in March 2020 with the first kit released for research use, according to its CORDIS report.

The only published report of the EIC project, filed for the period to February 2024 on CORDIS, describes work up to February 2022 only. It says EMPE narrowed development to two products, mfloDx MDR-TB and mfloDx preXDR-TB, built a manufacturing site in India able to make 2 million tests per month, implemented ISO 13485 procedures and produced 50,000 tests in trial batches. The MDR-TB kit was then under evaluation at India's National Institute for Research in Tuberculosis (NIRT), and the pre-XDR prototype was due to finish R&D by the second quarter of 2022. The report says nothing about the last two years of the project, and states no approval.

Capacity figures differ between sources. CORDIS gives 2 million tests per month, BioSpectrum quotes then global chief executive Raghavendra Goud Vaggu saying in July 2023: "We currently have a capacity to make 25 million kits", and the company flyer gives 9 to 24 million kits per year. None of the sources gives the number of kits sold.

1. Large-scale productionDeliveredISO 13485 plant in Hyderabad, per CORDIS and the company.
2. IVD approval of MDR-TB kit, late 2022LateCDSCO approval reported at the July 2023 launch, India only.
3. Clinical validationDeliveredStudies on 210 and 731 samples, 2024 and 2025.
4. Pre-XDR-TB kit on the marketNot achievedStill research use only as CircuLOK in September 2026.
5. WHO backingNot achievedNo WHO recommendation of the test found; the company's "WHO-recognised" claim is not explained.
6. Worldwide salesNot achievedNo sales figures; Swedish net sales near zero.

The Money

EMPE has been financed mostly by grants. Beyond the EIC award, the Gates Foundation committed $2,204,510 in November 2022 over 20 months "to develop a simple, low-cost molecular test for TB", according to its grant database. The company flyer puts total grants at "~7 M EUR", mainly from the Gates Foundation and the EIC. Almi lists EMPE in its Stockholm portfolio with a first investment in 2018. EMPE is not among the 319 companies on the EIC Fund's list of investments, as expected for a grant-only award. BioSpectrum reported that the company invested about Rs 25 crore in its Hyderabad production and R&D site.

The Swedish parent's accounts, as shown by Ratsit, record net sales of zero in 2021, 2022, 2024 and 2025 and SEK 0.1 million in 2023. Its income was booked almost entirely as other operating income, between SEK 7.2 million and SEK 17.6 million a year from 2021 to 2024; the summaries do not say what it consisted of. In 2025 operating income fell to SEK 5.5 million, of which SEK 5.2 million was the company's own development work capitalised on the balance sheet, and the loss widened to SEK 9.525 million from SEK 1.759 million, according to Hitta. Sales made by the Indian subsidiary would not appear in these figures, and its accounts were not available.

Cash fell from SEK 28.1 million at the end of 2022 to SEK 1.1 million at the end of 2025, while short-term debts to group companies rose to SEK 4.3 million. Equity rose from SEK 6.293 million to SEK 8.794 million in 2024 despite a loss of SEK 1.759 million, and to SEK 9.269 million in 2025 despite a loss of SEK 9.525 million, which implies about SEK 4.3 million and SEK 10.0 million of new capital in those years. Who provided it is not shown in the sources consulted, and no funding round has been announced.

Other EU Projects

EMPE was also one of 17 participants in INNOVA4TB, a Marie Skłodowska-Curie staff exchange network on tuberculosis innovation coordinated by the Germans Trias i Pujol research institute in Spain, with an EU contribution to EMPE of €23,092 between January 2019 and June 2024, according to CORDIS. The CORDIS summary of the EIC project mentions clinical validation partners in Spain and India.

Why Europe Should Care

Drug-resistant tuberculosis is part of the antimicrobial resistance problem that the Commission and member states in July 2022 identified as one of the top three priority health threats, and the Council adopted a recommendation on stepping up action against it on 13 June 2023, according to the European Commission. The EU/EEA reported 38,993 TB cases in 2023, according to the ECDC. EMPE's own flyer says the WHO European Region has the highest incidence of MDR-TB in the world. A low-cost, instrument-free resistance test would serve that need. So far, though, EMPE's announced approvals, its manufacturing and its published clinical studies are all in India, and no European approval of the EU-funded test has been announced.

The Verdict

EMPE Diagnostics and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.