Digitising diagnostic services

SigTuple is automating pathology labs to detect and analyse diseases

SigTuple Technologies, which raised $5.8 million this month from several investors, is developing solutions to digitise pathology labs using artificial intelligence (AI) and machine learning.

The Bengaluru-based start-up has a hub-and-spoke model of medical experts and telepathology labs and hospitals. AI and machine learning techniques are used to increase the efficiency of these specialists in digital diagnosis and analysis.

SigTuple works with 18 medical institutions, including labs and hospitals, to digitise disease screening and diagnostic services. It is trying to replace age-old pathology lab equipment with digital scanners and has created a platform-centric approach to provide solutions for automated analysis of blood, urine and semen.

“Though we are witnessing rapid digitisation, no one has applied AI to interpret medical images and videos. SigTuple’s founders have added a smartphone to the standard microscope for visual evidence,” said Endiya Partners Managing Director Ramesh B Byrapaneni, one of investors in the latest round of funding.

“Their cloud-based AI platform Manthana generates a report within 20 minutes of the screening, and the metrics can be reviewed by pathologists across the globe through the Internet. This is very useful for the people living in small towns and villages that face a shortage of specialists,” he added.

Opportunity

AI and deep learning can play a key role in automating diagnostic services. The Indian diagnostic services market was worth $5.4 billion in 2015 and was growing at 15-17 per cent a year, said Rohit Kumar Pandey, co-founder and chief executive officer of SigTuple.

“The primary use of funds in the latest round is to scale up commercial operations. Shonit, a blood smear analyser solution, is under clinical validation. We are planning its commercialisation very soon in India. Other solutions, Shrava for urine test and Aadi for semen test, are in advanced stages of development,” he added.

SigTuple is also developing solutions for chest x-rays and retinal scans. The company has filed five patent applications in India and two in the US. 

Chandigarh-based Advenio is another start-up using AI to detect retinal abnormalities and tuberculosis. Swedish firm Cellavision is working on a similar platform.

Business model

Diagnostic centres and pathology labs are possible customers for SigTuple because its solutions eliminate the need for pathologists to review samples. Its cloud-based platform Manthana uses a pay-per-use model, which charges labs for every report generated.

Telepathology labs serve more patients a day with consistent reports. SigTuple’s revenues depend on how fast this technology is adopted by doctors in the country.

“We offer the hardware to the telepathology lab at one-tenth the cost of regular equipment. This will save a lot in capital expenditure and the benefit can be passed on to patients,” Pandey said.    

 

Road ahead

SigTuple is focused on building the technology platform and getting it ready for commercial adoption. It is focusing on clinical trials of its solutions under the supervision of a principal investigator. 

SigTuple is also preparing for approval by the US Food and Drug Administration (FDA). It has started an internal analysis and is comparing its solutions with a predicate device. The FDA allows innovators to identify more than one predicate device to demonstrate substantial equivalence in certain circumstances.

US-based medical imaging analytics platform Arterys recently received the FDA’s nod for commercialisation of its cloud computing and deep learning application in the US and Europe. SigTuple plans to commercialise its solutions in the US by the first quarter of 2018 after regulatory approvals. It plans to enter not only regulated markets but also emerging markets like Southeast Asia and the Middle East.

According to the investors, SigTuple can change the diagnostic services market  the way WhatsApp has done in social media.  

Challenges

Coming from a technology background, SigTuple’s founders faced initial challenges in gaining the medical knowledge to set up an AI-assisted platform. They have tied up with a prominent laboratory in Bengaluru for medical data. With the help of doctors, the start-up had created a platform to predict annotations on medical data.

Now technology adoption and regulatory validation are the major hurdles. By building enough clinical evidence SigTuple could overcome this, Accel Partners principal Barath Shankar Subramanian said.

Accel invested in SigTuple in the seed round over a year ago. It recently led the Series A round.

The start-up will use the latest round of funding for regulatory clearances. As its solutions are classified  under in vitro diagnostic (IVD) medical devices, SigTuple requires self-certification. The Drugs Controller General of India (DCGI) has said that IVD devices do not come under its purview, according to Pandey.

Expert Take

SigTuple’s cloud-based Artificial intelligence (AI) platform is a very powerful disruptive innovation, which can be of immense benefit to health-care providers, especially those in the diagnostic space. It has tremendous scope to scale up at a rapid pace, and potential to replace the current practices with ease, and well adaptable in both the existing and new market space.

The technology can address many challenges of health-care providers, in terms of quality, trained manpower, timely delivery of reports, infrastructure, cost and accuracy. It has a multimillion dollar potential, with global utility.

The platform is sturdy and fairly validated. The need is to roll it out commercially in clinical settings. This will help gain acceptability from health care providers. Once done, the sky is the limit. The new funds will definitely help them achieve perfection and enter the commercial space.

All innovations, to some extent, represent uncertainty. Established players and traditional practices adopted by providers will definitely create some resistance. It can overcome this conflict by listing validated and verified data, associating with established service providers, strategic positioning and committed marketing, with technical reinforcement.

As the base platform is very scientific, it should be used for introducing diverse offerings, with a focus on regional need. Probably, a diverse portfolio will gain acceptability very fast. Once that happens, it will become an opportunity over a billion dollars.

Dr Ravi Gaur,  chief operating officer and lab director of Oncquest Laboratories