EIC podcast highlights rapid antibiotic resistance testing for tuberculosis and backing for EMPE Diagnostics

Brussels, April 14th 2023
Summary
  • The EIC podcast episode 6 spotlights a rapid test for antibiotic resistance in tuberculosis developed by EMPE Diagnostics.
  • EMPE Diagnostics has secured joint support from the European Innovation Council and the Bill and Melinda Gates Foundation to develop and scale the technology.
  • The episode features EIC programme manager Iordanis Arzimanoglou and EMPE co-founder and Vice CEO Pavan Asalapuram.
  • Rapid AMR tests could speed clinical decision making and stewardship but face validation, regulatory and deployment hurdles in low resource settings.

Rapid AMR testing for tuberculosis: what the EIC podcast revealed and why it matters

The European Innovation Council podcast series The game changers: from radical idea to innovative business published episode 6 on 14 April 2023. The episode focuses on a new diagnostic approach from EMPE Diagnostics that is described as drastically reducing the time needed to test tuberculosis for antibiotic resistance. The conversation brings together an EIC programme manager with clinical genetics expertise and the company co-founder to discuss development, commercialisation and scaling.

Episode snapshot and participants

Podcast series and episode:The EIC series explores how deep tech moves from lab to market and how EIC support helps scale disruptive innovations. Episode 6 examines a rapid antimicrobial resistance test for tuberculosis developed by EMPE Diagnostics.
Panel:Iordanis Arzimanoglou served as the EIC programme manager for health and biotechnology and participated as a technology expert. Pavan Asalapuram is co-founder and Vice CEO of EMPE Diagnostics and a pharmacist and clinical biotechnologist.

Why faster AMR testing for TB is important

Tuberculosis remains a major global health problem and drug resistance in Mycobacterium tuberculosis complicates treatment. Conventional methods to determine resistance can be slow. Delays in knowing whether a strain is resistant lead to inappropriate empiric treatment, worse patient outcomes and the continued spread of resistant strains. Faster diagnostics that reliably detect resistance can allow clinicians to tailor therapy sooner and support antibiotic stewardship efforts.

Antimicrobial resistance and tuberculosis explained:Antimicrobial resistance means pathogens are less susceptible to drugs that previously worked against them. In TB, resistance to first line drugs such as rifampicin and isoniazid creates multi drug resistant TB which requires longer, more toxic and more expensive treatment regimens. Rapid, accurate detection of resistance markers or phenotypic resistance helps guide therapy and reduce transmission of resistant strains.

The innovation and financing described in the episode

The podcast describes EMPE Diagnostics as having developed a test that drastically reduces the testing time for antibiotic resistance in TB. The company has attracted joint funding from the European Innovation Council and the Bill and Melinda Gates Foundation to develop, commercialise and scale the technology. The episode presents this as an example of deep tech moving from lab toward market with the backing of public and philanthropic funders.

Funding details and partners:The programme notes joint support from the EIC and the Bill and Melinda Gates Foundation. Public material linked to the EIC indicates that the Gates Foundation invested in EMPE Diagnostics with an amount reported as €3.2 million in a development or catalytic investment that the EIC programme manager helped secure.
StakeholderRoleFunding or activity
EMPE DiagnosticsDeveloper of the rapid AMR test for TBLead company advancing the diagnostic toward commercial use
European Innovation CouncilFunder and scaling support via programme management and EIC instrumentsProvided EIC support and visibility through the EIC podcast series
Bill and Melinda Gates FoundationPhilanthropic investor and partner for development and scaleReported investment of EUR 3.2 million to support advancement
Iordanis ArzimanoglouEIC Programme Manager for Health and BiotechnologyHosted the discussion and has a role in catalysing support
Pavan AsalapuramCo founder and Vice CEO of EMPE DiagnosticsPresented the company and technology on the podcast

Technical context and caveats

The podcast characterises EMPE Diagnostics technology as drastically faster at detecting TB resistance. The specific method is not fully detailed in the episode. In general, rapid AMR tests follow two broad approaches. Molecular tests detect genetic markers associated with resistance and can deliver results in hours. Rapid phenotypic tests aim to shorten culture based susceptibility testing to a few hours or days by accelerating growth detection or using surrogate biomarkers. Both approaches carry trade offs in sensitivity, specificity and scope of resistance markers covered.

Molecular versus phenotypic AMR testing:Molecular assays detect known resistance mutations and are fast. They cannot identify resistance mechanisms that are not captured by the chosen genetic markers. Phenotypic assays test whether the organism grows in the presence of a drug and therefore measure functional resistance. Traditional phenotypic tests are slower but can catch resistance that molecular panels miss. Rapid phenotypic formats seek to compress that timeframe but require robust validation.
Diagnostic performance and real world use:Any claim of drastic time savings must be matched by independent data on sensitivity, specificity, limits of detection and performance across different patient populations and specimen types. Implementation in clinical pathways requires clear evidence about concordance with reference methods and guidance on how to act on results to avoid misuse or over reliance on test outputs.

Regulatory, validation and deployment challenges

Promising diagnostics face multiple non technical barriers before they affect patient outcomes at scale. These include clinical validation studies in representative settings, regulatory approvals such as CE marking in Europe and WHO prequalification for global procurement, supply chain and manufacturing scale up, training of health workers, and integration with national TB programmes and antibiotic stewardship systems.

WHO prequalification and market access for diagnostics:WHO prequalification is often required for procurement by international buyers and many national programmes. The process examines quality, safety and performance. For diagnostics intended for low resource settings, additional attention to robustness, ease of use, cold chain requirements and cost per test will determine uptake.
Operational and clinical adoption issues:Faster results change clinical workflows. Health systems must ensure clinicians act on results in line with stewardship guidelines and that supply chains can deliver alternative drugs when resistance is detected. Without these links, diagnostic speed alone will not improve outcomes.

EIC and the European innovation ecosystem context

The EIC supports deep tech through funding, coaching and visibility. Programme managers such as Iordanis Arzimanoglou work across portfolios to build strategic intelligence, catalyse partnerships and help companies navigate scale up. The EIC also seeks to leverage co investment and to connect companies to wider support services that include regulatory, business acceleration and investor networks.

Role of EIC Programme Managers:Programme managers coordinate technology portfolios, identify strategic opportunities, and help beneficiaries prepare for market entry. In this case the podcast itself is a visibility tool and the programme manager has engaged in steps to catalyse investment for the company.

Risks, unanswered questions and next steps

The episode provides a useful introduction to a potentially important diagnostic. It leaves some key questions open. Independent peer reviewed data is needed on diagnostic performance across settings. The specific technology approach and the range of drugs and resistance mechanisms detected should be transparent. The pathway to regulatory approvals, procurement by public health programmes and sustainable manufacturing needs to be made explicit. Finally, integration with clinical practice and stewardship measures will determine whether faster results change patient outcomes.

Immediate priorities for credible scale up:Rigorous multicentre clinical validation, regulatory submissions including WHO prequalification where relevant, manufacturing scale up with quality systems, and partnerships with national TB programmes and procurement agencies are critical next steps. Ongoing post market surveillance will be necessary to monitor real world performance and impact on AMR and patient outcomes.

Conclusion

The EIC podcast episode offers an example of how public and philanthropic backing can accelerate a potentially high impact health innovation. Rapid AMR testing for TB is an important objective with clear benefits in theory. The real test will be in independent validation, regulatory clearance, and the practical realities of deployment in health systems that need resilient supply chains and clear stewardship pathways. Support from the EIC and foundations helps, but claims of dramatic impact require rigorous evidence and careful planning to become clinical practice.

Disclaimer: The original EIC post includes a statement that the material is for knowledge sharing and not the official view of the European Commission or other organisations. This article aims to reorganise and contextualise the information provided in that EIC podcast announcement and related EIC materials while noting outstanding evidence and implementation questions.