Bioftalmik patents an innovative non-invasive limbic insufficiency diagnosis system

Bioftalmik, a Basque biotechnology company specialised in the ophthalmology field, has patented an innovative non-invasive diagnosis system to detect limbic insufficiency.

The new diagnosis developed by Bioftalmik is of a molecular nature, and there is no place for human interpretation. It is more sensitive and specific than conventional impression cytology, does not provide false results, which allows for making a reliable diagnosis, and making surgical decisions directed at selecting the right people for receiving cornea and limbo transplants.

Limbic insufficiency (LI) is the partial or total loss of the limbocorneal stem cells, inducing an invasion of cells from the conjunctive onto the cornea. These symptoms lead to a corneal clouding, which if affected in the centre, produces a reduction in visual sharpness or even loss of vision. Limbic insufficiency diagnosis is very important, as it is the deciding factor for the treatment to be followed in each patient.
For the development of non-invasive diagnosis systems, Bioftalmik has specialised in extracting genetic and protein material from Impression Cytology (IC). To obtain the samples, some specific membranes are used that are deposited on the ocular surface, exerting a small amount of pressure. After extracting the genetic material from the cornea cells, the expression of the MUC 5AC gene has been studied, specific to the secretory conjunctival cells called “goblet cells”. The detection of

this gene in the cornea is what will indicate if there is an injury to the limbo or not. The innovation in this diagnosis system lies in the design of specific primers (biotechnological tools) that will allow us to recognise the MUC 5AC gene in the cornea.

This new limbic insufficiency diagnosis system was presented in the 85th Congress of the Spanish Ophthalmology Association, held on 23-26 September in Santander, in the paper presented by Dr. Jaime Etxebarria (Cornea Director in the Ophthalmology Department of the Cruces Hospital), in the research session.

It is forecasted that in four months at the most, this diagnosis system also provide information on the severity of the limbic insufficiency.

Bioftalmik is currently offering this diagnosis service, although it is working on a Diagnosis Kit so that other laboratories can make their own assessments with this new system. The marketing of this Kit is foreseen to be ready for the end of 2010.