US guidelines boost Cellestis' credibility, marketing push

By Melissa Trudinger
Tuesday, 11 February, 2003

Melbourne diagnostics company Cellestis has received a major boost with the release of the US Centre for Disease Control and Prevention (CDC) guidelines for its Quantiferon-TB diagnostic test for tuberculosis (TB).

The guidelines provide information about the populations that should be tested with the new diagnostic test and strategies for follow-up testing and treatment.

According to Cellestis CEO Tony Radford, the guidelines have helped the company's ongoing efforts to market the test to US laboratories.

"What it's done for us effectively is give us tremendous exposure," he said. "We now have a lot more currency. Our levels of enquiries have gone up a thousand per cent."

Cellestis is aiming to market the diagnostic test, which is cheaper, faster, more sensitive and less prone to false positives than the prevailing Tuberculin Skin Test (TST), to public health laboratories, prison facilities and other laboratories with high-risk populations, as well as to the military.

Radford explained that the company's sales strategy was to go after the public health laboratories first, as they tended to have the most knowledge about the disease and were a source of information to other laboratories, which would follow their lead. But most public health companies were waiting for the guidelines to be published before considering the new test.

"It has given us credibility and made it easier to deal with the major reference laboratories," he said.

In the guidelines, the CDC recommended that QuantiFERON be used in high-risk populations without the need to follow up with a skin test to confirm before treatment. In low-risk groups Cellestis' test was recommended as an initial screen, with a follow-up skin test to confirm actual cases of TB.

This would provide huge savings in the costs of testing, said Radford, and would make it very attractive to groups like the military, which has large TB screening programs for new recruits.

The CDC recommendations also covered all of the markets for the test targeted by Cellestis, Radford said.

"The CDC guidelines specifically say it can be used in prisons and the military," he said. "These groups wouldn't buy it if it wasn't for that."

One disappointment, Radford said, was the CDC's reluctance to recommend the test as a method of finding recent contacts of individuals with active TB infections, or contact tracing. He said that the CDC was waiting for more data to come in from studies being performed by the CDC and by Cellestis.

Cellestis recently completed a Japanese study demonstrating that its second generation test was able to pick up 82 per cent of active untreated TB infections, compared to the TST, which only picked up 66 per cent.

"The CDC is justifiably a moderately conservative group, and there is a lot at stake for them if things go wrong," he said.

Cellestis is also moving forward with its second generation TB test, which will test for immune responses against specific TB proteins, making the test more suitable for testing individuals immunised with the BCG vaccine. Studies have been completed in Japan and are underway in Denmark and a number of other countries, said Radford.

The company plans to file for regulatory approval in Japan by the end of the year, and aims to be marketing the product in some countries by the end of the year. "We have a lot of momentum right now," Radford said.

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