Cellestis teams up to test TB

Diagnostics developer Cellestis (ASX: CST) has entered a collaboration to test and distribute a tuberculosis diagnostic designed specifically for the Japanese market.

The Melbourne company announced the agreement with Nichirei Corporation of Tokyo for the clinical testing, registration, marketing and distribution of its second generation QuantiFeron - TB test.

The first generation of this diagnostic, which was recently approved by the US Food and Drug Administration, is an immune system test that picks up the presence of tuberculosis.

But in Japan, unlike most other parts of the developed world, universal tuberculosis vaccinations have rendered current diagnostic tests relatively unreliable.

For this reason, Cellestis and Nichirei have entered a collaboration to develop a tool that would be more effective in diagnosing tuberculosis in a population where vaccination is frequent.

Managing director Dr Tony Radford said that while Japan was the primary focus in the product's development, it would also have applications in other countries with a similar problem to Japan.

Radford said about 25 million tests for tuberculosis were conducted annually in Japan and, with the nation's health ministry declaring a state of emergency over the disease, said the situation represented a major opportunity for Cellestis.

"We are extremely pleased to have a company of Nichirei's size and expertise as our Japanese partner," he said.

"Nichirei has excellent infrastructure and distribution networks in Japan, and the Nichirei Biosciences Division has proven expertise in both gaining regulatory approval and marketing of medical diagnostics in Japan."

Radford said the product was currently in clinical trials in Japan and was about three years away from market.

Tuberculosis, or BCG, vaccinations, although widely used in developing nations, do not prevent tuberculosis infection in adults but is known to prevent infant deaths from the disease.

Repeated use of the vaccinations, however, corrupts skin testing for the infection and can lead to false-positive reactions.

Because of this situation, Japan relies mostly on chest X-rays but does not have a reliable early detection test for tuberculosis infection.

Cellestis says its second-generation test would be completely unaffected by the BCG vaccination status of the individual being tested.

Nichirei Biosciences Division executive officer general manager Takeshi Ara said his company was excited by the prospect of a highly specific tuberculosis test in Japan.

"Cellestis and Nichirei will be working together to gain registration of the second-generation QuantiFeron-TB product," he said.

"We believe there is a large medical need for such a product in Japan."

Nichirei Corporation, which had sales topping $8 billion last financial year, has diverse business interests spanning temperature controlled logistics, foodstuffs, processed foods, biosciences and real estate.