Announcement

EMPE Diagnostics AB announced on 10 September 2026 that it will unveil its CircuLOK product range at the 81st National Conference on Tuberculosis and Chest Diseases (NATCON 2026) scheduled for 1–4 October in Patiala, India.

Product Portfolio

The CircuLOK suite comprises three modular molecular tests:

  • CircuLOK MDR‑TB – detects resistance to rifampicin and isoniazid.
  • CircuLOK pre‑XDR‑TB – adds detection of fluoroquinolone resistance to the MDR panel.
  • CircuLOK FLQ‑TB – a standalone reflex‑testing option for fluoroquinolone resistance only.

The modular design allows laboratories to select the resistance panel that matches their patient population and budget and to expand coverage as needs evolve.

Manufacturing and localisation

All CircuLOK tests are manufactured at EMPE’s ISO 13485‑certified facility in Hyderabad, India, aligning with the Government of India’s “Make in India” initiative. The Hyderabad site also hosts expanded research, development and clinical validation activities.

Regulatory status

At NATCON the products will be introduced as Research Use Only (RUO). EMPE is concurrently pursuing approval from the Central Drugs Standard Control Organisation (CDSCO) and performance evaluation by the Indian Council of Medical Research (ICMR), following the same regulatory pathway used for its previously approved TB diagnostics in India.

Executive comment

Jan Buch Andersen, Chief Executive Officer of EMPE Diagnostics, stated: “Drug resistance in tuberculosis doesn’t stand still, and neither can diagnostics. CircuLOK gives laboratories the flexibility to adapt their resistance‑testing coverage as needs evolve, without being locked into a single closed platform. Our goal is to make clinically actionable resistance information available wherever TB is diagnosed.”

Future development

EMPE indicated that it is developing molecular solutions to extend resistance coverage across the full WHO‑recommended BPaLM regimen from a single, accessible testing platform.

Company background

EMPE Diagnostics was founded in Stockholm, Sweden, in 2015. The company builds on research originating at the Karolinska Institutet and uses its proprietary Pli‑RCA (Padlock probe‑linked Rolling Circle Amplification) platform to combine TB identification with antibiotic‑resistance profiling at the point of first diagnosis. More information is available at https://empediagnostics.com.

Contact

Media contact: Jan Buch Andersen, CEO, sales@sales.empediagnostics.com, +46 70 919 9249 (Stockholm, Sweden).