MUMBAI, INDIA, July 20, 2026: OptraSCAN, Inc., a California-headquartered digital pathology and image analysis company, in which Molbio Diagnostics Limited acquired a majority stake in 2025, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance (K260755) for the OptraSCAN System. The clearance covers the integrated OptraSCAN System comprising the OS-Ultra Whole Slide Scanner, a color display monitor, and a workstation running the company’s ImagePath Image Management Software, including HER2 Image Analysis Software. Together, the system supports pathologists in the review and assessment of HER2 expression in clinical practice.
HER2 assessment plays a critical role in breast cancer characterisation and therapeutic decision-making. As pathology laboratories worldwide continue to transition towards digitised workflows, image analysis technologies are increasingly adopted to support standardisation, reproducibility, and efficiency in pathology
review processes.
The FDA 510(k) clearance represents a significant milestone for OptraSCAN and reflects years of product development, engineering and clinical validation across its global teams. The achievement also highlights the value of Molbio Diagnostics’ strategic investment in OptraSCAN, expanding its portfolio of clinically validated diagnostic technologies. It further demonstrates the group’s commitment to developing diagnostic solutions that meet the rigorous regulatory standards of the U.S. Food and Drug Administration.
“This FDA clearance is an important milestone in our journey to advance digital pathology globally,” said Abhi Gholap, Founder and CEO of OptraSCAN. “As digital pathology adoption continues to accelerate worldwide, the FDA clearance further strengthens OptraSCAN’s position as a trusted technology partner for hospitals, diagnostic laboratories, academic medical centres, and life sciences organisations. It also underscores the company’s continued investment in innovation through its global teams across the United States and India.”
Commenting on the significance of the development for the global pathology community, Dr. Reena Nakra, Chief Scientific Officer, Dr Lal PathLabs, said, “Digital pathology is becoming an increasingly important part of modern pathology. We have had the opportunity to work with OptraSCAN and regulatory milestones such as U.S. FDA clearance provide additional confidence in the quality of its digital pathology platform and the clinical robustness of this technology. This milestone is an encouraging step forward for the continued adoption of digital pathology.”
About OptraSCAN
Headquartered in California, USA, OptraSCAN is engaged in the business of automating scanning device technology with tumor and immune cell intelligent scoring systems, dedicated to transforming the future of pathology services through advanced digital slide scanners & AI-driven solutions. It provides digital pathology solutions, offering a range of digital pathology scanners, AI-powered analysis tools, and telepathology services, enabling remote consultations and collaboration.
About Molbio Diagnostics Limited:
Molbio Diagnostics Limited is an innovative point-of-care diagnostics company. With a commitment to providing rapid, accurate, and cost-effective diagnostic solutions. The company’s flagship Truenat® real-time PCR platform is globally recognised and endorsed by the World Health Organisation (WHO), enhancing infectious disease management worldwide. Molbio is dedicated to improving healthcare accessibility and quality with innovative diagnostics that meet global standards.
Regulatory note: This release describes an FDA 510(k) clearance, not FDA approval. The OptraSCAN System is cleared only for the use described above (HER2 scoring, Dako HercepTest™, FFPE breast tissue). Any statement outside this scope — other biomarkers, other tissue types, autonomous diagnosis, or treatment-outcome claims — should not be included without separate regulatory review.
DISCLAIMER:
Molbio Diagnostics Limited is proposing, subject to receipt of requisite approvals, market conditions and other considerations, to make an initial public offer of its equity shares and has filed a draft red herring prospectus (“DRHP”) with Securities and Exchange Board of India (“SEBI”) with the Registrar of Companies, Goa, Daman and Diu at Panaji. The DRHP is available on the website of the Company at www.molbiodiagnostics.com/investors, the website of the SEBI at www.sebi.gov.in, as well as on the websites of the book running lead managers, Kotak Mahindra Capital Company Limited at www.investmentbank.kotak.com, IIFL Securities Limited at www.iiflcap.com, Jefferies India Private Limited at www.jefferies.com and Motilal Oswal Investment Advisors Limited at www.motilaloswalgroup.com, and the websites of the stock exchange(s) at www.nseindia.com and www.bseindia.com, respectively. Any potential investor should note that investment in equity shares involves a high degree of risk and for details relating to such risk, see “Risk Factors” of the RHP, when available. Potential investors should not rely on the DRHP for any investment decision.
The Equity Shares have not been and will not be registered under the U.S. Securities Act or any state securities laws in the United States, and unless so registered, and may not be offered or sold within the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. Accordingly, the Equity Shares are being offered and sold outside the United States in “offshore transactions” as defined in and in reliance on, Regulation S under the U.S. Securities Act and the applicable laws of the jurisdictions where such offers and sales are made.