Molbio Diagnostics

Molbio Diagnostics Limited is an Indian medical diagnostics company headquartered in Verna, Goa, that develops molecular diagnostic technologies.[1] Founded in 2000, the company developed the Truenat platform, a portable real-time PCR system used to diagnose infectious diseases including tuberculosis, HIV, and hepatitis.[2]

The Truenat platform is recognized by the World Health Organization (WHO) for the initial detection of tuberculosis and rifampicin resistance.[3] Following clinical studies,[4] including research published in The Lancet,[5] the technology has been adopted by national health programs in over 85 countries.[6][7]

In 2025, Molbio was awarded the Kochon Prize by the Stop TB Partnership, the world's largest award for tuberculosis.[8][9]

History and operations

Incorporated in October 2000 in Goa, India, Molbio Diagnostics initially developed reagents for in vitro diagnostics.[10] Its work in molecular diagnostics began through a collaboration with Bigtec Labs, a Bengaluru-based research firm specializing in lab-on-a-chip technologies. In 2011, the two entities formed a joint venture to commercialize the Truenat platform,[11][12] and in 2015, Bigtec Labs merged into Molbio, functioning as its research and development unit.[13]

In 2017, following the acquisition of Tulip Diagnostics by PerkinElmer, Natarajan exited that firm and focused on Molbio's operations. In the same year, Truenat was validated for use under India's National TB Elimination Programme. A fully automated version of the platform was released in 2018 and was deployed by the Indian Council of Medical Research during the 2018 Nipah virus outbreak in Kerala.[14]

Between 2019 and 2020, Molbio received regulatory licenses from the Central Drugs Standard Control Organisation for multiple PCR-based diagnostic assays, including tests for tuberculosis, HIV, hepatitis, and COVID-19.[15] During the COVID-19 pandemic, its COVID-19 diagnostic tests were used for decentralized testing at transit hubs and rural healthcare centers.[16][17] In 2022, Molbio reached a valuation exceeding $1 billion following an $85 million investment from Temasek Holdings.[18]

In March 2023, the company partnered with Global Fund and USAID to expand global access to its portable molecular TB tests.[19] In 2025, Molbio was awarded the Kochon Prize by the Stop TB Partnership, becoming the first private sector recipient of the award. The recognition was granted for the company's role in decentralizing TB diagnostics in low-resource settings.[20] As of 2025, the company reported exporting its diagnostic products to over 85 countries and formally converted into a public limited company.[21]

Technology and products

The Truenat platform is a battery-operated, real-time PCR system designed for point-of-care testing.[22] It uses automated nucleic acid extraction and is capable of operating without a stable power supply.[23][24][25] As of 2025, the platform supports over 40 assays for diseases including malaria, HIV, and human papillomavirus (HPV).[26][27][28] In April 2025, Molbio launched India's first indigenously developed HPV test kits for cervical cancer screening, validated by AIIMS and the WHO's International Agency for Research on Cancer.[29]

Radiology and digital pathology

Following its acquisition of Prognosys Medical Systems in 2022, Molbio entered the portable radiology segment with the ProRad Atlas Ultra X-ray system.[30] In 2024–2025, the company invested in the San Jose-based digital pathology firm OptraScan, expanding its portfolio into whole-slide imaging technologies. Through a partnership with UE LifeSciences, Molbio also distributes the iBreastExam handheld device for breast cancer screening.[31]

References

  1. ^ Prasad, R. (2020-01-16). "TB diagnostic test developed in India has high accuracy, says WHO". The Hindu. ISSN 0971-751X. Retrieved 2026-02-07.
  2. ^ Purohit, Manju; Ssengooba, Willy; Cox, Helen; Ugarte-Gil, Cesar; Sserubiri, James; Tootla, Hafsah; Velen, Kavindhran; Székely, Rita; Penn-Nicholson, Adam (2025-06-27). "Performance evaluation of the Molbio diagnostics Truenat MTB Ultima/COVID-19 multiplex assay for TB and COVID-19 case detection among people with symptoms suggestive of tuberculosis—a study protocol for clinical trials". Frontiers in Public Health. 13 1620210. Bibcode:2025FrPH...1320210P. doi:10.3389/fpubh.2025.1620210. ISSN 2296-2565. PMC 12245902. PMID 40655205.
  3. ^ Perappadan, Bindu Shajan (2020-07-03). "WHO nod for Truenat rapid molecular assays for TB". The Hindu. ISSN 0971-751X. Retrieved 2026-02-07.
  4. ^ Bigio, Jacob; van Gemert, Wayne; Kaiser, Brian; Waning, Brenda; Pai, Madhukar (2021-12-01). "Asia emerges as a hotbed of diagnostic innovations for tuberculosis". Journal of Clinical Tuberculosis and Other Mycobacterial Diseases. 25 100267. doi:10.1016/j.jctube.2021.100267. ISSN 2405-5794. PMC 8408512. PMID 34485710.
  5. ^ Khosa, Celso; Cossa, Marta; Leukes, Vinzeigh; Hella, Jerry; Sabi, Issa; Watson, Mikaela; Larsson, Leyla; Garcia-Basteiro, Alberto; Riess, Friedrich; Schumacher, Samuel G; Nguenha, Dinis; Manjate, Patricia; Elisio, Delio; Ntinginya, Nyanda Elias; Mangu, Chacha. "Implementing the Molbio Truenat platform and tuberculosis assays versus standard of care at primary care clinics for the detection and treatment of tuberculosis in Mozambique and Tanzania (TB-CAPT CORE): a cluster-randomised trial". The Lancet Primary Care. 1 (4) 100028. doi:10.1016/j.lanprc.2025.100028.
  6. ^ Krishnan, Janaki (2025-09-15). "Molbio exports Truenat for diagnostic care to over 85 countries". BusinessLine. Retrieved 2026-02-07.
  7. ^ "Test-kit makers rue 'total' export ban". m.economictimes.com. Retrieved 2026-02-12.
  8. ^ Hyun-a, Yeom. "Molbio Diagnostics wins Kochon Prize for advancing TB diagnostics in India and globally". The Chosun Ilbo. Retrieved 2026-02-12.
  9. ^ "World's largest TB prize illuminates Indian Molbio's tech innovation reaching the unreached". ModernGhana. 2025-10-30. Retrieved 2026-02-12.
  10. ^ Panda, Sushmita (21 October 2022). "FE Exclusive | We will continue to add more disease testing varieties to our Truenat technology: Sriram, Director, Molbio Diagnostics". Financial Express. Retrieved 2026-02-04.
  11. ^ Research (India), Council of Scientific & Industrial (2013). Annual Report - Council of Scientific and Industrial Research. Publications & Information Directorate.
  12. ^ Kaur, Navjot; Michael, Joy S.; Toley, Bhushan J. (2019-10-25). "A modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings". Scientific Reports. 9 (1): 15367. Bibcode:2019NatSR...915367K. doi:10.1038/s41598-019-51873-8. ISSN 2045-2322. PMC 6814773. PMID 31653930.
  13. ^ Krishnan, Janaki (2024-09-22). "Diagnostics". BusinessLine. Retrieved 2026-02-07.
  14. ^ Basu, Mohana (8 September 2021). "TrueNat test kit first in India to get 'emergency use' approval for Nipah virus diagnosis". ThePrint.
  15. ^ "Development of 'TrueNat' Innovation System in India for Detection of Tuberculosis and COVID-19: A System Based Perspective" (PDF). Research and Development System for Countries.
  16. ^ "Covid 19 testing specialist Molbio Diagnostics eyes $1 billion revenue in 3 5 years - BusinessToday". Business Today. 2021-08-03. Retrieved 2026-02-07.
  17. ^ "Goa diagnostic company's tuberculosis device could help scale up Covid-19 testing - The Economic Times". m.economictimes.com. Retrieved 2026-02-12.
  18. ^ Jayakumar, P B (27 September 2022). "Temasek invests in Covid-19 testing specialist Molbio Diagnostics". Fortune India.
  19. ^ Mathew, Joe (2023-04-05). "Pharma's R&D Ambitions Go Global". Fortune India. Retrieved 2026-02-07.
  20. ^ Shukla, Shobha; Ramakant, Bobby (2025-11-10). "World's largest TB prize illuminates Indian Molbio's tech innovation reaching the unreached | Highland Post". Retrieved 2026-02-07.
  21. ^ Podishetti, Akash (2025-08-24). "Diagnostics company Molbio files DRHP with Sebi for an IPO". The Economic Times. ISSN 0013-0389. Retrieved 2026-02-07.
  22. ^ Das, Sohini (2021-08-25). "Molbio Diagnostics developing more tests for Truenat platform". www.business-standard.com. Retrieved 2026-02-12.
  23. ^ Khosa, Celso; Cossa, Marta; Leukes, Vinzeigh; Hella, Jerry; Sabi, Issa; Watson, Mikaela; Larsson, Leyla; Garcia-Basteiro, Alberto; Riess, Friedrich; Schumacher, Samuel G; Nguenha, Dinis; Manjate, Patricia; Elisio, Delio; Ntinginya, Nyanda Elias; Mangu, Chacha (2025). "Implementing the Molbio Truenat platform and tuberculosis assays versus standard of care at primary care clinics for the detection and treatment of tuberculosis in Mozambique and Tanzania (TB-CAPT CORE): a cluster-randomised trial". The Lancet Primary Care. 1 (4) 100028. doi:10.1016/j.lanprc.2025.100028.
  24. ^ Ahmed, Issam (2026-02-12). "Trump to Revoke Key Climate Science Ruling, Putting US Emissions Limits at Risk". TheQuint. Retrieved 2026-02-12.
  25. ^ Ouma, Samwel Doe (2023-07-26). "MolBio's new technology 'Truenat Machine' to expand rapid TB diagnosis and rifampicin resistance". Health Business. Retrieved 2026-02-12.
  26. ^ "Odisha Bigyan Academy" (PDF). Odisha Bigyan Academy.
  27. ^ Bigio, Jacob; van Gemert, Wayne; Kaiser, Brian; Waning, Brenda; Pai, Madhukar (2021-12-01). "Asia emerges as a hotbed of diagnostic innovations for tuberculosis". Journal of Clinical Tuberculosis and Other Mycobacterial Diseases. 25 100267. doi:10.1016/j.jctube.2021.100267. ISSN 2405-5794. PMC 8408512. PMID 34485710.
  28. ^ Khosa, Celso; Cossa, Marta; Leukes, Vinzeigh; Hella, Jerry; Sabi, Issa; Watson, Mikaela; Larsson, Leyla; Garcia-Basteiro, Alberto; Riess, Friedrich; Schumacher, Samuel G; Nguenha, Dinis; Manjate, Patricia; Elisio, Delio; Ntinginya, Nyanda Elias; Mangu, Chacha (2025-10-01). "Implementing the Molbio Truenat platform and tuberculosis assays versus standard of care at primary care clinics for the detection and treatment of tuberculosis in Mozambique and Tanzania (TB-CAPT CORE): a cluster-randomised trial". The Lancet Primary Care. 1 (4) 100028. doi:10.1016/j.lanprc.2025.100028. ISSN 3050-5143.
  29. ^ Perappadan, Bindu Shajan (2025-04-25). "TH25 Bindu India's first indigenously developed HPV test kits for cervical cancer screening validated". The Hindu. ISSN 0971-751X. Retrieved 2026-02-12.
  30. ^ Datta, PT Jyothi (2023-02-21). "Molbio Diagnostics inches closer to e-clinic roll-out with foray into imaging". BusinessLine. Retrieved 2026-02-07.
  31. ^ www.ETHealthworld.com. "Molbio Diagnostics, UE LifeSciences Partner to Expand Access to Early Breast Cancer Detection". ETHealthworld.com. Retrieved 2026-02-07.
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