The Evolution of In-Vitro Diagnostics: Trends and Future Prospects

S. MohanKumar, CEO & Director, Peerless Biotech Pvt. Ltd

 The Evolution of In-Vitro Diagnostics

S. Mohan Kumar, CEO & Director of Peerless Biotech Pvt. Ltd., in conversation with India Pharma Outlook, shares insights on how diagnostic innovation, particularly point-of-care and molecular diagnostics, is transforming healthcare delivery in India. He emphasizes how companies are enhancing accuracy, affordability, and accessibility through technology, AI integration, and public-private collaborations. He also highlights the growing importance of personalized medicine and effective infectious disease management in decentralized and underserved regions. A seasoned biopharma leader with over 22 years of experience, Mohan Kumar brings expertise in strategic management, operational excellence, and biotechnology innovation.

According to him, diagnostic companies are scaling rapid in-vitro solutions across decentralized settings by:

  • Simplifying test procedures and optimizing supply chain management for greater accessibility and affordability.
  • Miniaturizing diagnostic devices and leveraging lab-on-a-chip technologies to enhance portability.
  • Utilizing mobile platforms and AI-powered diagnostics to ensure rapid, accurate results even in remote areas.
  • Integrating data analytics to streamline deployment and monitoring across point-of-care (PoC) networks.

With rising demand for point-of-care testing, how are diagnostic companies scaling rapid in-vitro solutions while ensuring accuracy, affordability, and ease of deployment across decentralized settings?

The concept of POCT has been established for more than 30 years. One of the first POCT tests is the ‘Glucose test’ with glucometer. A very large number of companies started manufacturing POCT tests over the last 10 years and the menu increased rapidly covering a very broad range of parameters.

Diagnostic companies are addressing the rising demand for point-of-care (POC) testing by leveraging technology, streamlining processes (Made test procedure simple, better supply chain management and data analytics), and focusing on accessibility with cost effective solutions.

The diagnostic companies are scaling rapid in-vitro solutions by miniaturizing devices, lab on a chip, utilizing mobile platforms, and implementing AI-powered diagnostics to ensure accuracy, affordability, and ease of deployment across decentralized settings.

What role is molecular diagnostics playing in shifting the clinical diagnostic landscape, especially for infectious diseases and personalized treatment decisions?

Molecular diagnostics is playing a transformative role in reshaping the clinical diagnostic landscape globally, and its impact in India is particularly significant given the country’s vast and diverse population, high burden of infectious diseases, and growing emphasis on personalized medicine. Here’s a detailed look at how molecular diagnostics is shifting the diagnostic paradigm, with special reference to India:

Early and Accurate Diagnosis of Infectious Diseases

Rapid Detection: Molecular diagnostic tools such as PCR (Polymerase Chain Reaction), RT-PCR, and next-generation sequencing (NGS) allow for the rapid and highly specific detection of pathogens. This is crucial in a country like India, where diseases such as tuberculosis (TB), HIV, dengue, malaria, and COVID-19 remain prevalent.

Drug Resistance Detection: In India, molecular tests like CBNAAT (Cartridge-Based Nucleic Acid Amplification Test) have revolutionized TB diagnostics by detecting both the presence of Mycobacterium tuberculosis and resistance to rifampicin — a major advance in tackling drug-resistant TB, which is a major public health concern.

Role in Personalized and Precision Medicine

Oncology: Molecular diagnostics helps identify genetic mutations and biomarkers in cancers (e.g., BRCA in breast cancer, EGFR mutations in lung cancer). This enables tailored therapies that are more effective and less toxic, a shift from one-size-fits-all approaches to personalized oncology care.

Pharmacogenomics: India is beginning to integrate pharmacogenomic testing to understand how individuals respond to drugs based on their genetic makeup. This is essential for avoiding adverse drug reactions and optimizing drug efficacy in chronic conditions like diabetes, cardiovascular diseases, and cancer.

Point-of-Care and Decentralized Testing: The advent of portable molecular platforms is enabling point-of-care (PoC) diagnostics in rural and remote parts of India, where access to centralized labs is limited. Technologies like isothermal amplification (e.g., LAMP) and microfluidics-based devices are being developed and deployed for field diagnostics, especially during outbreaks (e.g., COVID-19, Nipah virus).

COVID-19: A Catalyst for Molecular Diagnostics in India

The pandemic accelerated the adoption of molecular diagnostics:

  • India rapidly scaled up RT-PCR testing infrastructure.
  • Private and public labs increased their molecular testing capacities.
  • Companies like Molbio Diagnostics (TrueNat) and Mylab emerged as key players, promoting indigenous development and Make-in-India solutions.

This pandemic-driven expansion laid the foundation for molecular testing across multiple diseases beyond COVID-19.

Public Health Surveillance and Epidemiology

Molecular tools are being used for genomic surveillance of pathogens (e.g., SARS-CoV-2 variants) and are beginning to be applied in tracking antimicrobial resistance (AMR) patterns, essential for national programs such as the National Centre for Disease Control (NCDC) and ICMR initiatives.

Challenges in India’s Molecular Diagnostics Landscape

Cost and Accessibility: Despite falling prices, advanced molecular tests remain costly for many patients in rural or low-income settings.

Skilled Manpower: There is a shortage of trained personnel in molecular diagnostics outside urban centers.

Regulatory and Quality Standards: Ensuring quality and accuracy across diverse labs remains a challenge.

Awareness and Integration: Many clinicians still rely on traditional diagnostics due to lack of familiarity or trust in newer molecular techniques.

Future Outlook and Opportunities

Government initiatives like Ayushman Bharat and increased investment in healthcare are improving access to advanced diagnostics. Public-private partnerships and collaborations with international organizations (e.g., FIND, WHO) are facilitating the rollout of molecular testing tools. Integration of AI and big data with molecular diagnostics will further drive predictive and preventive healthcare models in India.

How do public-private collaborations help in addressing affordability gaps and accessibility challenges in diagnostic testing across tier-2 and tier-3 healthcare markets?

Public-private collaborations (PPCs) play a vital role in improving the affordability and accessibility of diagnostic testing in tier-2 and tier-3 healthcare markets, which often suffer from limited infrastructure, shortage of skilled professionals, and financial constraints.

Here’s how these collaborations help,

Cost Reduction through Shared Investment

Public sector: Offers infrastructure, subsidies, or land for diagnostic centers. Private sector: Provides advanced technology, equipment, and operational efficiency.

Impact: Shared risk and investment reduce costs, making diagnostics more affordable for patients in underserved areas.

Infrastructure Development

PPCs help establish diagnostic labs or mobile units in semi-urban and rural areas, where public health infrastructure is often lacking. Private partners bring modular, scalable lab setups, while the government supports them through policy, logistics, or workforce.

Technology Transfer and Innovation

Private companies introduce automation, AI-driven diagnostics, and point-of-care testing, which improve turnaround times and reduce operational costs. These innovations are critical in low-resource settings where skilled manpower and large-scale labs are scarce.

Supply Chain Efficiency

Public systems often struggle with fragmented supply chains. Private partners contribute robust procurement and distribution systems for diagnostic reagents, kits, and consumables. This improves test availability and minimizes stockouts in remote areas.

Capacity Building and Training

Private players train healthcare staff and lab technicians under government programs or CSR initiatives. Continuous skill development ensures consistent quality of diagnostic services and addresses the skilled workforce gap.

Data Integration and Disease Surveillance

Digital health records and integrated diagnostic systems from private partners enhance disease tracking and public health decision-making. Early detection of outbreaks or trends becomes possible even in remote regions.

Improved Access through Mobile and Tele-diagnostics

Mobile diagnostic vans and telemedicine platforms supported by PPPs bring services directly to underserved populations. This is particularly useful in tier-2/3 cities where travel to urban centers for diagnostics is a barrier.

Sustainable Business Models

PPPs often adopt hybrid pricing models, cross-subsidizing low-income patients with higher-paying customers or institutional tie-ups (like insurance or employer-sponsored care). This ensures affordability without compromising sustainability.

Real-World Examples

India’s Ayushman Bharat Health and Wellness Centres (HWCs) partner up with private labs for diagnostics under government reimbursement schemes. Rashtriya Swasthya Bima Yojana (RSBY) empaneled private diagnostic centers to offer free/low-cost services to low-income families. PATH & private diagnostic firms collaborated in Africa and Asia to bring GeneXpert machines and other rapid diagnostic tests to remote settings.

How are AI and data analytics transforming result interpretation, and what safeguards are in place to ensure diagnostic consistency and clinical reliability?

AI and data analytics are revolutionizing diagnostics and laboratory medicine in India by improving accuracy, speed, and accessibility. However, a strong regulatory framework, clinical oversight, and ethical considerations are essential to ensure diagnostic consistency and reliability. India is making strides with policy-level initiatives (like ICMR guidelines and NDHM), but successful integration requires continuous monitoring, validation, and a commitment to patient safety and equity. AI and data analytics are increasingly transforming diagnostics and laboratory medicine in India, with significant implications for result interpretation, operational efficiency, and clinical decision-making.

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