Lord’s Mark Industries Limited, in partnership with the Centre for Materials for Electronic Technology (C‑MET), announced that its AI‑powered, radiation‑free wearable breast cancer screening technology has progressed to the final clinical‑trial stage. The device combines high‑precision thermal sensors with AI‑driven temperature mapping to identify abnormal temperature patterns that correspond to cellular‑level breast cancer abnormalities, offering a painless, portable, battery‑operated alternative to conventional radiation‑based imaging.
Phase 2 trials, aimed at achieving 98% detection accuracy, are scheduled to commence in January 2027 across India, the United States, Great Britain and Europe. The trials will evaluate the technology’s ability to detect cancer at the cell level in a non‑invasive manner. Earlier clinical trials completed in India demonstrated accurate identification of cases evaluated during those studies, and the data generated will feed into ongoing clinical and regulatory assessments.
The Technical Committee has approved the conduct of the final clinical trials in the United States, Great Britain and Europe, subject to each jurisdiction’s regulatory requirements. Lord’s Mark is simultaneously pursuing regulatory clearances: CDSCO approval is in process in India, while the company is aligning with European conformity requirements, UK regulatory pathways, and the US FDA framework. The firm targets completion of the final trials and key regulatory milestones before March 2027, with commercial placement of the product planned for April 2027, contingent on successful validation and approvals.
Market context underscores the relevance of the technology. In 2024, 2.4 million women were diagnosed with breast cancer worldwide and approximately 694,000 deaths were recorded. The global breast cancer diagnostics market was valued at USD 5.9 billion in 2025 and is projected to reach USD 11.4 billion by 2033, expanding at a compound annual growth rate of 8.8%. Imaging currently accounts for 51.6% of the market, while advances in mammography, 3D tomosynthesis, MRI, ultrasound, AI‑assisted imaging, liquid biopsy and biomarker‑based diagnostics are creating new opportunities for earlier and more accurate detection. The International Agency for Research on Cancer (IARC) projects more than 3 million new cases annually by 2040, emphasizing the need for accessible and timely screening.
Lord’s Mark has also made formal representations to relevant authorities seeking inclusion of the technology in national breast cancer screening programmes and to the Insurance Regulatory and Development Authority of India (IRDAI) for potential insurance coverage. These efforts aim to improve affordability and broaden access, especially in remote villages and underserved regions where electricity supply may be limited.
Sachidanand Upadhyay, Managing Director of Lord’s Mark Industries Limited, stated that the approval of the final clinical‑trial stage marks a pivotal milestone, moving the innovation toward broader clinical validation and global commercialization. He emphasized the company’s focus on establishing a robust clinical and regulatory pathway for an accessible, radiation‑free, and affordable breast cancer screening solution.
The collaboration with C‑MET leverages C‑MET’s research and development expertise alongside Lord’s Mark’s manufacturing and distribution capabilities, with the broader objective of developing and commercialising indigenous healthcare technology at scale.
For further information, visit https://lordsmark.com/. (Disclaimer: This press release is provided under an arrangement with NRDPL; PTI takes no editorial responsibility.)