India's Health Fight: How New Tech Aims to Beat TB and HPV

PUNE, India – December 08, 2025

At the VIROCON 2025 conference this week, a presentation by CoSara Diagnostics is drawing attention not just for its scientific data, but for what it represents: a critical step forward in India's long-standing battle against two of its most formidable public health challenges. Behind the clinical terminology and preclinical study results for new tuberculosis (TB) and human papillomavirus (HPV) tests lies a story of innovation aimed directly at the front lines of community healthcare. CoSara, a joint venture between Utah-based Co-Diagnostics and India's Ambalal Sarabhai Enterprises, is showcasing a point-of-care platform that could fundamentally change how these diseases are detected, managed, and ultimately, contained.

The Pressing Need: Confronting India's Silent Epidemics

To understand the significance of this development, one must first grasp the scale of the crises India faces. The nation carries the heaviest burden of tuberculosis in the world, accounting for an estimated 2.8 million cases and a staggering 27% of the global total in 2022. The government's ambitious goal to eliminate TB by 2025 hinges on its ability to rapidly identify and treat new cases to break the chain of transmission.

Traditional diagnostic methods, while foundational, have limitations that hinder this effort. Sputum smear microscopy, common in rural areas, can miss cases, while the gold-standard culture method can take weeks to yield a result—a dangerous delay during which an infected individual can unknowingly spread the disease.

Simultaneously, India is grappling with the devastating impact of HPV, the primary cause of cervical cancer. The country accounts for nearly a quarter of the world's cervical cancer deaths. While effective screening can prevent most of these deaths, access remains a major barrier. Centralized laboratory testing and Pap smears require infrastructure, trained personnel, and multiple patient visits, logistical hurdles that are often insurmountable for women in remote or underserved communities. This gap in diagnostic access leaves millions vulnerable to a preventable cancer.

"The challenge has always been getting the right test to the right person at the right time," explains a public health researcher specializing in infectious diseases in South Asia. "For both TB and HPV, delays in diagnosis lead to worse outcomes for the patient and continued spread in the community. We need tools that can deliver lab-quality results without requiring a lab."

A New Frontier: The Promise of Point-of-Care PCR

This is precisely the gap that Co-Diagnostics and CoSara aim to fill with their Co-Dx PCR platform. The technology brings the power of Polymerase Chain Reaction (PCR)—a highly accurate molecular method for detecting DNA or RNA—out of the centralized lab and into clinics, mobile health units, and primary care centers. The platform is designed to be a rapid, easy-to-use system that can deliver results in under an hour.

The tests currently advancing through preclinical studies in India are specifically tailored to these challenges. The MTB test is designed for rapid detection of Mycobacterium tuberculosis, while the multiplex HPV test can simultaneously identify eight different genotypes of the virus, including three high-risk types strongly linked to cancer.

This "point-of-care" approach represents a paradigm shift. For a patient with a persistent cough in a rural village, it could mean a definitive TB diagnosis and the start of treatment in a single visit, rather than a multi-day journey to a district hospital. For a woman attending a local health camp, it could mean an immediate HPV screening result, allowing for on-the-spot counseling and linkage to follow-up care, dramatically reducing the number of patients lost in the system.

Experts believe this decentralization is a game-changer. "PoC PCR has the potential to democratize diagnostics," notes a diagnostic industry analyst. "By removing the need for complex infrastructure and extensive training, you empower frontline health workers to make faster, more informed decisions. This is crucial for strengthening health systems and achieving equity in healthcare access."

The CoSara Strategy: A Blueprint for Local Impact

Bringing transformative technology to a market as vast and complex as India requires more than just a good product; it requires a deep understanding of the local landscape. Co-Diagnostics' strategy hinges on its joint venture, CoSara Diagnostics. This partnership with the established Indian conglomerate Ambalal Sarabhai Enterprises is a masterclass in strategic collaboration.

Instead of simply importing and selling its technology, the company is embedding it within the Indian ecosystem. CoSara operates a manufacturing facility in Ranoli, Gujarat, which is critical for several reasons. Local production aligns with the Indian government's "Make in India" initiative, potentially providing regulatory and commercial advantages. More importantly, it helps control costs, manage the supply chain, and tailor products to the specific needs of the Indian market.

Furthermore, the ASE Group provides invaluable local expertise and an existing distribution network. Navigating India's rigorous regulatory body, the Central Drugs Standard Control Organisation (CDSCO), is a complex process. The research shows that IVD devices like these are considered high-risk (Class C or D) and require extensive clinical performance evaluations at designated Indian labs before market approval can be sought. Having a local partner with experience in this domain is a significant asset.

This joint venture model demonstrates a commitment to building sustainable capacity within India, rather than simply extracting value. It's a strategy that prioritizes impact and integration, recognizing that the most successful innovations are those that are developed and delivered in partnership with the communities they aim to serve.

The Path Forward: Navigating Science and Regulation

The announcement at VIROCON 2025 that preclinical data supports advancement to full clinical performance testing is a major milestone. This isn't just a corporate update; it's the gateway to the final, most crucial phase before the technology can reach patients.

Phase I and II preclinical studies for the TB test involved over 550 specimens to establish early sensitivity, specificity, and concordance with existing tests. Similarly, the HPV test has been optimized and refined using hundreds of clinical specimens to ensure it can accurately differentiate between high- and low-risk genotypes.

Now, the technology will enter formal Clinical Performance Evaluation (CPE), a mandatory step under CDSCO rules. This process involves rigorous testing in real-world clinical settings, with performance verified by national reference laboratories. It is a meticulous, evidence-based process designed to ensure that any new diagnostic tool is safe, effective, and reliable for the Indian population.

While Co-Diagnostics' financial reports indicate a post-pandemic revenue dip, the company maintains a substantial cash reserve of over $60 million, providing the necessary runway to fund these extensive and costly trials. The journey from the lab bench to the patient's side is long and fraught with scientific and regulatory hurdles. The progress of CoSara's MTB and HPV tests illustrates the dedication required to move beyond a promising idea to a validated, impactful service. This careful, step-by-step approach, combining global innovation with local execution, offers a powerful model for how to build resilient health systems capable of meeting the needs of all citizens.