Molbio eyes overseas growth after OptraScan secures USFDA clearance

Molbio Diagnostics plans to expand its overseas business through subsidiary OptraScan after the latter secured USFDA clearance, while diversifying beyond tuberculosis-focused public-health revenues.

Molbio Diagnostics is looking to expand its overseas business through its US-based digital pathology subsidiary OptraScan, which secured US Food and Drug Administration (USFDA) clearance in July for a system used to assess HER2 status in breast cancer biopsy samples, as the molecular diagnostics company seeks to diversify its predominantly tuberculosis- and government-led revenue base.

 

OptraScan received USFDA 510(k) clearance for its OptraSCAN System for HER2 scoring, which is used to analyse digitised pathology slides from breast cancer tissue biopsies.

 

OptraScan is in discussions with large laboratory networks to deploy its digital pathology products across the US, said Indraneil Borkakoty, president – corporate strategy, investor relations and mergers and acquisitions, Molbio Diagnostics. He did not indicate how the expansion could change Molbio's domestic-overseas revenue mix, citing initial public offering (IPO)-related restrictions on forward-looking statements.

 

 

Molbio's overseas revenue declined 29.5 per cent to Rs 139.04 crore in FY26, while domestic revenue increased 58.7 per cent to Rs 1,306.64 crore. The overseas share of revenue consequently fell to 9.6 per cent from 19.3 per cent a year earlier.

 

Borkakoty attributed the decline to logistical disruptions rather than a structural weakening of export demand.

 

"The export decline mentioned in the RHP is essentially what we view as a one-off event," he said. "Because of the Gulf situation, there was a problem with logistics. Most of the shipments go to Africa and, with the Gulf routes being disrupted, there was a delay in those shipments."

 

Molbio acquired nearly 20 per cent of OptraScan in October 2024 and raised its holding to 60 per cent in October 2025. It invested $30 million, partly through debt raised for the second tranche.

 

"The entire acquisition of OptraScan was by way of a fresh infusion of equity. We did not buy a single share from any of the existing shareholders, so the entire money is with OptraScan," Borkakoty said. "Only a small component has been used. They received USFDA approval in July, and this money will now be deployed to grow that business."

 

OptraScan reported a loss of Rs 11.14 crore for the five months during which it was consolidated in FY26. Borkakoty described it as a start-up whose principal focus over the past year was securing regulatory approval for its digital pathology technology.

 

Its machines scan pathology slides and convert them into digital images. An artificial intelligence (AI) layer can help pathologists interpret and prioritise slides requiring closer examination.

 

"Pathologists in laboratories are heavily loaded with work, and biopsies are still largely examined using microscopes," Borkakoty said. "OptraScan converts the slides into digital images, while an AI layer can help the pathologist identify which slides need to be examined more closely."

 

The US expansion could provide Molbio with another growth avenue as it seeks to broaden a business dominated by TB testing and public health procurement.

 

TB accounted for 96.02 per cent of the 17.56 million Truenat kits sold in FY26 and generated Rs 982.01 crore, or 70.20 per cent of finished-goods revenue. Truenat kits are single-use molecular diagnostic tests that run exclusively on Molbio's portable, real-time polymerase chain reaction (PCR)-based platform to detect TB and other infectious diseases near the point of care.

 

Molbio's largest customer contributed 56.52 per cent of finished-goods revenue, while governments and international aid agencies together accounted for 84.56 per cent.

 

Shiva Sriram, president, Molbio Diagnostics, said the concentration reflected the public health priorities for which Truenat was deployed.

 

"The question is not about dependence on any one product or one government. It is about the impact we are creating through the platform and what the global priorities are," Sriram said.

 

"When Covid came, the priority changed and machines deployed under the TB programme were repurposed for Covid testing. The priority has now come back to TB, which is why there has been a significant uptake of TB tests," he added.

 

Molbio plans to extend the multi-disease platform to programmes including hepatitis testing and human papillomavirus (HPV) screening for cervical cancer. It has a pipeline of 34 assays covering 22 additional infectious and non-communicable diseases.

 

"Our goal is to populate primary care centres globally with as many devices as possible, create a multi-disease opportunity and integrate with multiple disease programmes," Sriram said. "This is already happening with diseases such as hepatitis and with HPV for cervical cancer screening. These programmes are not yet as advanced as the TB programme, but they are getting there."

 

Molbio's IPO consists of a fresh issue of up to Rs 200 crore and an offer for sale of up to 9.166 million shares. The price band has been set at Rs 768-807 per share.

 

Around Rs 105 crore of the fresh proceeds will fund an integrated research and development (R&D) centre in Bengaluru, while about Rs 72.5 crore will be used largely for automation at its test-kit facilities in Goa and device manufacturing facility in Visakhapatnam.

 

Molbio's R&D workforce increased from 69 employees in FY24 to 153 in FY26, although it commercialised only one assay during FY26.

 

"R&D is about building capability over time until it matures into a platform that can become significantly impactful," said Dr Chandrasekhar Nair, executive director and chief technology officer, Molbio Diagnostics.

 

"We are developing assays for the current platform and taking them into regulated environments, including CE-IVDR and World Health Organization (WHO) prequalification, where the burden of evidence has to be significant," Nair said.

 

"Beyond that, we have created the technological capability to build an entirely new set of platforms that can add to our revenues and open newer avenues for growth," he added.