Announcement

EMPE Diagnostics AB, a Stockholm‑based molecular diagnostics company founded in 2015, 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 designed for tuberculosis drug‑resistance profiling:

  • CircuLOK MDR‑TB – detects resistance to rifampicin and isoniazid;
  • CircuLOK pre‑XDR‑TB – extends coverage to fluoroquinolone resistance in addition to rifampicin and isoniazid;
  • CircuLOK FLQ‑TB – provides a standalone reflex‑testing option for fluoroquinolone resistance.

These tests allow laboratories to select the resistance panel that matches their patient population and budget, and to expand coverage as needs evolve.

Manufacturing and Regulatory Pathway

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

At NATCON, the products will be introduced as Research Use Only (RUO) while EMPE pursues formal approval from the Central Drugs Standard Control Organisation (CDSCO) and performance evaluation in partnership with the Indian Council of Medical Research (ICMR), following the same regulatory pathway as its existing India‑approved TB diagnostics.

Executive Comment

"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," said Jan Buch Andersen, Chief Executive Officer of EMPE Diagnostics.

Future Development

Looking ahead, EMPE 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 originated from research at the Karolinska Institutet and leverages 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.