Biocurious: Behind Optiscan’s quest to ditch biopsies and bring pathology into the modern era

• Optiscan’s confocal laser endomicroscopy promises to revolutionise cancer surgery so that it’s done right first time, every time
• The company has turned to upending outdated pathology practices with real-time and remote analysis
• The company also seeks to facilitate robotic surgery and telehealth consultations between surgeon and pathologist

With the rise of robotic and minimally invasive surgery and other innovations, medicine has moved into the 21st century.

But one important discipline remains stuck in the 19th century: the pathology sector, where glass slides and paperwork still prevail.

In the case of cancer surgery, the practice of sending a frozen tissue sample to the lab remains the same since Dr William Mayo – founder of Minnesota’s esteemed Mayo Clinic – requested one from pathologist Dr Louis B Wilson in 1905.

Optiscan (ASX:OIL) CEO Dr Camile Farah notes doctors and surgeons have to wait for the results of a biopsy to be returned from the lab – and that can take days, or even weeks.

“Every field of medicine relies on pathology, one way or the other,” he says.

“Surgeons operate partly blind and critical decisions cannot be made on the spot.”

Notoriously painful procedures, biopsies are the “weakest link in clinical medicine today”.

Meanwhile, outdated pathology practices impose a heavy burden on the healthcare system, “given the amount of wastage, consumables, equipment and the skills required to interpret images”.

‘Into every nook and cranny’

Optiscan is a leader in a non-invasive imaging method called confocal laser endomicroscopy, or CLE.

CLE eliminates the age-old and unreliable method of analysing tissue samples under a traditional microscope.

“We have spent nearly 20 years validating and miniaturing the tech, to the degree the surgeon has a microscope in the palm of their hands,” Farah says.

CLE involves a single optical fibre in a probe projecting laser light on to live tissue, treated with fluorescent dye.

This creates real-time digital microscopic images at a magnification 1000 times that of computed tomography (CT), or magnetic resonance imaging (MRI) scanning.

The device itself is four centimetres long and only 2.5 millimetres wide.

“We can get into any nook and cranny in your body and we can do it live and in real time,” Farah says. “The images are equivalent in quality to today’s images.”

Optiscan’s key clinical focus currently is on breast cancer. This seems apt, given today marks the start of Breast Cancer Awareness Month.

The aim is simple: to treat cancers properly the first time – and every time.

Sci-fi becomes reality

Optiscan in February unveiled its pathology tool, Inform – one of three devices the company has released over the past 18 months.

The company’s flagship device, Invue, is for precision-guided surgery.

The company also has revealed a variant, Inspecta, for veterinary surgery.

After all, the need for real-time diagnosis is just as relevant for operating on dogs and cats as it is for humans.

Inspecta is moving to validation studies with the Minnesota College of Veterinary Medicine. The work will also focus on breast and mouth cancers, which are common in dogs and cats respectively.

The company’s earliest device, Invivage is for oral cancer imaging.

“We are device agnostic, our tech fits into any endoscope,” Farah says.

“This broadens our market appeal, because it allows doctors using a particular system to stay with that and incorporate our solution.”

Optiscan’s story is not just about the device, but integrating the hardware with software to enable analytics and decision support.

“To make surgeons and pathologists lives easier, we are building our own artificial intelligence-based decision support software solutions,” Farah says.

“This is not science fiction any more, this is reality.”

‘Netflix’ for pathologists

In league with Canada’s Prolucid Technologies, Optiscan has developed a telepathology tool to ‘minimum viable product’ stage.

“It’s what we call Netflix for pathologists,” Farah says.

“In the same way as you stream movies, we can stream pathology images anywhere in the world, with no delay to the observable eye.

“You can have a surgeon on Sydney and a pathologist in Florida and they could be working on the same case at the same time.”

Optiscan also has a collaboration with the famed Mayo Clinic to integrate robotics with Optiscan’s platform.

Especially in the US, robotics is taking over from traditional and laparoscopic surgery.

The idea is to compensate surgeons for the lack of tactile contact when operating remotely and robotically.

Gathering evidence

None of Optiscan’s devices is yet to win regulatory approval, with Invue and Inform in “clinical evidence gathering stage”.

Both tools are being tested in a 50-patient breast cancer trial at the Royal Melbourne Hospital and Frances Perry House.

The trial was launched in June, with a readout expected in the next 12 months.

Invue will provide real time (in vivo) assessment of breast cancer margins,  following lumpectomy  procedures.

The idea is that the surgeons remove all the cancer and don’t leave any at the edges.

In the case of breast cancer, Farah says, an astonishing 25% to 30% of cases require second surgery because the clinician has missed excising part of the tumour.

Optiscan expects the study data to support a marketing submission to the US Food & Drug Administration (FDA), with a view to lodging the paperwork in calendar 2026.

Invivage, meanwhile remains a slow burn.

The company sought FDA approval in 2022.

The agency advised that as Optiscan’s proposed approach of delivering the contrast agents orally was ‘novel’ – they’re usually delivered intravenously – the approval process would be elongated.

The company agreed to use the intravenous method. But this makes the product applicable to a smaller market of oral surgeons rather than dentists.

Optiscan continues to discuss a “suitable regulatory pathway” with the FDA.

Licking the copycats

Armed with $17.75 million from a recent rights issue, Optiscan has the armoury to fund its transition from a medical device maker to a broader digital healthcare provider.

Ultimately, Optiscan seeks to do for pathology what CT and MRI did for radiology.

“We believe Optiscan is the next great leap in medicine,’ Farah says. “No one in the world has this tech for these applications.”

Others have tried, with Farah pointing to multiple ‘copycat’ devices.

“But the image resolution is poor and adoption has been very low,” he says.

“That’s why we have had the take-up by Mayo, with other [partners] to come.”

Ultimately, Optiscan stands to benefit from high barriers to entry, attractive hardware margins and significant recurring software-as-a-service revenue.

Development has been a two decades-long trudge, but the company looks to be getting to the pointy end of things.