• Optiscan’s platform could help with shortage of pathologists in Australia and globally
  • Platform particularly useful in diagnosing malignant tumours and pre-cancerous lesions in surgery
  • Optiscan seeking US FDA De Novo clearance for its InVivage product intended for oral cancer imaging


Special Report:  An ASX biotech company could help alleviate concerns about a growing shortage of pathologists in Australia and internationally delaying medical test results, including for serious diseases such as cancer.

Concerns about a shortage of pathologists has hit the headlines in Australia with Royal College of Pathologists of Australasia CEO Dr Debra Graves saying there are “too few pathologists to do the work that needs to be done”.

Optiscan (ASX:OIL) is pioneering new standards of care in digital pathology and precision surgery, developing, field testing and perfecting its single fibre-optic miniaturised confocal endomicroscope for the past two decades.

CEO and managing director Dr Camile Farah, a trained clinician and pathologist who has been leading the company for the last two years, says the OIL platform could help reduce the bottleneck in pathology testing.

“Our real-time digital pathology platform has been developed to work in a dynamic fashion, similar to what radiologists have been using in teleradiology for the last couple of decades,” Farah says.

“Our hardware and software solutions will allow pathologists to receive digital images from clinicians and surgeons in real-time, streamlining their workflow and allowing them to get through their caseload in a much faster manner.”

“Our digital solutions, including our telepathology portal and AI algorithms, will allow clinicians and pathologists to triage lesions and surgical resections, and free up pathologists to concentrate on difficult cases.”


Benefits in intraoperative pathology

Farah says to address shortfalls in pathologists and improve workflows, the sector will need to embrace clinically validated digital technology such as that developed by OIL.

He says the OIL platform proves especially beneficial for intraoperative pathology, aiding in the diagnosis and removal of malignant tumours and pre-cancerous lesions during surgeries.

He says the technology empowers surgeons and pathologists to collaborate instantly, ensuring precise tumour removal without waiting for lab results or complicated procedures like frozen sections.

“Consequently, this minimises the need for additional surgeries and testing, and also frees up more of the pathologists’ time,” Farah says.

“Using real-time scanning, our probe captures detailed 3D imaging at the microscopic level, providing immediate information for on-the-spot diagnosis and enabling informed decisions during surgery.”

“A pathologist can turn to a surgeon and say ‘I have examined the whole tumour for you on-the-spot’.”


Improving diagnosis of oral cancer

Meanwhile, in the UK there are concerns that challenges in obtaining appointments with NHS dentists might have contributed to a rise in deaths related to mouth cancer.

The Oral Health Foundation says mouth cancers led to the death of more than 3,000 individuals in the UK in 2021 – a 46% increase from 2,075 deaths reported a decade earlier.

OIL is currently seeking US Food and Drug Administration (FDA) De Novo clearance for its first-in-class InVivage product which is an intra-oral digital microscope intended for oral cancer imaging, after earlier this year getting feedback from the FDA.

The FDA told OIL that due to the first-in-class nature of InVivage and novelty of its intended use, it could not evaluate substantial equivalence of its device/drug combination product due to the absence of a predicate.

Farah and his colleagues recently published a paper showing OIL technology can be used for on-the-fly diagnosis of oral cancer and precancer.

The work was published in the prestigious Journal of Oral Pathology and Medicine.

Equally, researchers at the University of Melbourne have shown that the InVivage can be used to detect a whole myriad of mouth lesions including cancer and precancer, work they have published in Frontiers in Oncology.

“The Optiscan platform is a slide-free optical biopsy system that allows clinicians and pathologists to diagnose cancer and precancerous pathology in real-time,” Farah says.

“It saves the patient time and anxiety in getting a diagnosis from the clinician on the spot and streamlines the pathology workflow.”

Farah says once FDA clearance for the device is granted, Optiscan will roll out the technology in the US.

“We have received significant interest for our oral imaging device because of its ability to generate microscopic images of oral tissues in real-time, and the potential for it to be used as non-invasive oral cancer screening platform,” he says.

OIL is also working towards other FDA De Novo applications for use of its technology in other clinical procedures including breast surgery and colorectal imaging.


‘Digital pathology will replace the glass slide’

Farah says OIL is accelerating the path to market, developing multiple hardware and software combinations and running parallel studies for new FDA submissions.

Farah says there is broad appeal for their technology from:

  • Doctors and dental clinics for oral cancer diagnosis
  • Operating theatres for intraoperative surgical assessment
  • Endoscopy suites for monitoring chronic conditions such as Crohn’s disease
  • Pathology lab looking to modernise current analogue procedures

“The global pathology laboratories market size accounted for $325 billion in 2022 and is estimated to hit around $715 billion in 2032,” Farah says.

“The majority of this relies on traditional glass-based analogue and labour-intensive procedures.”

Farah says OIL’s digital solution removes the need for tissue biopsy, sample collection, specimen processing, and delays in getting glass slides to pathologists.

“Our digital platforms re-imagine the pathology workflow, spreading that between clinician and pathologist, and saving pathology laboratories billions of dollars in consumable and labour costs,” he says.

“It’s only a matter of time before digital pathology will replace the glass slide.”


This article was developed in collaboration with Optiscan, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.