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Technology Development & Commercialisation Office

Technology Portfolio - Diagnostics



Biomarkers
In the diagnosis of many ophthalmic conditions, current methods rely on subjective clinical evaluation, rather than objective endpoints. Tear protein-based analysis has shown promise as an objective diagnostic medium, and can additionally serve to aid in drug development and patient stratification. The presence of certain proteins in tears could also serve as warning signs of impending flares of other related non-ophthalmic diseases. Commercially available kits that detect tear proteins only indicate whether the result is above or below a certain threshold, are not useful for monitoring changes in protein levels, and are not multiplexed. Thus, it would be beneficial to have a point of care diagnostic device that would fulfil this function in assessing varying levels of a number of tear-based biomarkers.


The Technology
We have identified quantitative biomarkers derived from the tears of patients that have a significant association with dry eye disease (DED), Meibomian gland dysfunction, glaucoma, age-related macular degeneration (AMD), as well as flares in systemic lupus erythematosus (SLE). Pairing these with a point-of-care device will not only aid in the diagnosis of the target diseases, but also, via specific biomarkers, give possible indications of the underlying problem as well as enable the monitoring of treatment efficacy.


Target Market
The number of people with dry eye disease is expected to reach 250 million by 2022, up from 195 million in 2012. The incidence of dry eye is greater in Asia, driven in part by an ageing population and changing lifestyles such as the increased use of contact lenses and computers. The total potential market for diagnosis and treatment monitoring for DED and SLE is expected to exceed 1.5 billion patients from year 2014 onwards, while the number of patients with AMD is expected to reach 288 million by 2040.


Current Stage of Development
A total of four patents covering the use of ocular fluids biomarkers for diseases diagnosis have been filed, covering DED, AMD, SLE and keratoconus. We are seeking commercial or academic partners to work with us on marrying these to a POC device for research and clinical use.


Categories: Diagnostics Biomarkers


Intellectual Property:

  1. Method of diagnosing thyroid disease (WO2014189467A1)
  2. A process for identification of biomarkers for keratoconus progression (WO2014106833A1)
  3. Investigation of mucosa dryness conditions (US grant US8080428B2)
  4. Identification of novel biomarkers of flares of systemic lupus erythematosus (EP Grant EP3044594B1)


Pupillometer
Some ophthalmic conditions, such as primary  open-angle glaucoma (POAG) and diabetic retinopathy (DR), are subclinical at the early stages, and patients typically do not report their symptoms until the disease has progressed and the effects have become more severe. Currently, screening for glaucoma and DR is based on a number of examinations which are costly and difficult to implement on a community level. Thus, there is a need for a simple and cost-efficient method to detect and screen for these conditions reliably and on a large scale.


The Technology
Our pupilometer-based device can be used to evaluate visual function by measuring the pupillary light reflex, and so can objectively detect and monitor conditions affecting the retina and optic nerve, including POAG and DR.


Target Market
The current market size for retina dysfunction screening, inclusive of glaucoma and DR-related diagnostic equipment inclusive of ophthalmoscopes, perimeters, tonometers and fundus cameras is approximately US$430 million. We foresee that the addressable market size for retinal dysfunction screening is at least as large as the market size of similar diagnostic equipment, and possibly larger, if the technology is employed beyond the hospital and clinic settings.


Current Stage of Development
We have carried out clinical validation based on a lab prototype and shown the close correlation between pupillary light reflex and different stage of glaucoma and DR. A handheld pupilometer (beta protototype) has been designed and developed to cater for the needs, including low cost eye screening in the community centre or in remote areas, as well as for comprehensive eye examinations in eye hospital or clinics.


Categories: Devices, Diabetic Retinopathy, Glaucoma


Intellectual Property:

  1. A method and system for monitoring and/or assessing pupillary responses, (PCT/SG2017/050305) National phase application filing in US (US15536199, Pending); EU (EP20150870472, Pending); China (CN 201580069231, Pending)
  2. Hand held ophthalmic and neurological screening device, PCT/SG2018/050204.


GonioPEN
Gonioscopy, which is the imaging of the iridocorneal angle, is used in the diagnosis of both closed- and open-angle glaucoma, as well as during glaucoma surgery. However, current gonioscopes come with several drawbacks: using such devices causes patient discomfort and must be carried out by an eye specialist, so only 50% of patients undergo the examination. When used to assist surgery, the large contact base increases the chances of infection and can impede the surgeon.


The Technology
The GonioPEN is a small, handheld probe that provides greater convenience and efficiency in angle imaging. It requires less expertise to operate than a conventional gonioscope, and the inclusion of a recording function allows later evaluation by an eye specialist or an automated diagnostic software. A smaller area of contact with the eye results in reduced patient discomfort and presents a smaller obstruction during surgery.


Target Market
With the ageing global population and rising prevalence of ophthalmic conditions, glaucoma is expected to affect 80 million people by 2020. With several advantages over conventional gonioscopes, the GonioPEN is a superior alternative for use in both diagnosis and treatment.


Current Stage of Development
We have developed a pen-sized probe (called GonioPEN, in alpha prototype stage) which causes no discomfort. The team has just completed a pilot study on GonioPEN with 20 patients at SNEC and the results showed high correlation with the gold standard, i.e. examination by glaucoma specialist with gonioscopy. Prototype refinement including wireless connectivity and a plug-and-play interface are underway.


Categories: Devices, Glaucoma, Diagnostics


Intellectual Property: 

  1. Probe for iridocorneal angle imaging, PCT/SG2015/050341; National phase application filing in US (US15514422, Pending); EU (EP20150843466, Pending); Japan (JP2017516287A, Pending)