Resources
Tuberculosis Kills More People Than Any Other Infection. Here’s How We’re Building the Company to Change That.
Fredrik Orre
CFO, EMPE Diagnostics
Tuberculosis is still the world’s deadliest infectious disease, and drug-resistant TB is spreading faster than the tools most clinics have to detect it. At EMPE Diagnostics we have spent years building those tools – and as CFO I get to watch the science turn into products, approvals and, increasingly, a real business.
I want to be concrete about where we are, because it is further along than many people assume. Our mfloDx™ MDR-TB test is approved by India’s CDSCO and launched. Around it we have built a differentiated portfolio of faster, simpler, freeze-dried tests covering TB, MDR-TB and pre-XDR-TB, with the lyophilised versions launching this quarter. Five strong clinical-trial centres are recruited and running – NITRD Delhi, CARE Chennai, Amaltas Indore, NITRD Patiala and NIMS Hyderabad. Commercially, we have reached out to close to 100 distributors across EMEA, LATAM and APAC, backed by new sales portals and a CRM. And through all of it, costs have stayed on or under budget with a clean audit.
One thing I want more people to understand about EMPE: this is a platform, not a single product. Every test in our portfolio – TB, MDR-TB, pre-XDR-TB and the new resistance markers in our pipeline – is built on the same core technology. Each new product reuses validated science rather than starting from zero, which lowers the cost and the risk of every launch that follows and opens a route into other diseases from one proven base.
“The hard, early, risky science is largely behind us; what is ahead is reach.” — Fredrik Orre, CFO
Patient Capital, Managed Seriously
Building this kind of company takes patient capital, and much of ours has been non-dilutive. There is a comfortable myth that grants are the easy money because you never pay them back. The truth is the opposite – they are reimbursement-based, they demand co-funding and serious reporting, and I manage them as real capital. But used well they fund the deep clinical and development work that is otherwise hard to finance this early. We have applied for a number of grants in the Medtech space. And EMPE became the first company financed by both the European Innovation Council and the Bill & Melinda Gates Foundation – two of the most rigorous non-dilutive backers in global health, whose due diligence is a validation in itself.
Manufacturing for Others, Too
We are also putting our manufacturing facility in Hyderabad to broader use: we now offer ISO 13485-certified CMO production services to other clients from the same plant that makes our own tests.
2026: The Year of Execution
The rest of 2026 is about execution. We complete our clinical trials and file for regulatory approval of our pre-XDR and MDR tests, with an expected six-month route to approval. Our focus is an impactful market launch of the new products and securing further ICMR approvals to support the expansion. The hard, early, risky science is largely behind us; what is ahead is reach.
Let’s Connect
So an open invitation to distributors, clinical and manufacturing partners, grant and global-health organisations, and anyone working to close the gap in TB diagnosis: I would like to connect. Let’s put a fast, affordable TB resistance test in the hands of the clinicians that need it most.
Learn more: empediagnostics.com