Cellestis gets FDA approval, raises $11m

Australian immunodiagnostics company Cellestis (ASX:CST) has received approval from the FDA for its second generation QuantiFERON-TB Gold tuberculosis diagnostic test.

QuantiFERON-TB Gold is a blood-based test that replaces the traditional Mantoux or tuberculin skin test (TST) offering greater accuracy and reduced incidence of false positives -- in a Japanese study last year the test picked up 82 per cent of TB infections compared to 66 per cent picked up by the TST. The test is also said to be simpler to perform than the original QuantiFERON-TB test, with the entire test essentially performed in the blood collection tube, allowing for it to be used in the field.

The FDA approval clears the way for the company to market and sell the test in the US.

To assist with the costs of marketing the test in the US, Cellestis has also completed a placement to sophisticated and institutional investors at a price of AUD$2.40 per share, raising $11 million. Existing institutional shareholders and 17 new institutional investors took part in the placement, which was managed by Lodge Partners.

Up to $4 million further will be raised through a share purchase plan, due to open on December 14 and close on December 29, allowing shareholders to purchase between $1000 and $5000 at the institutional purchase price of $2.40.

"With FDA approval of QuantiFERON-TB Gold the company will be scaling up marketing internationally to meet the market opportunity," said managing director Dr Tony Radford in a statement. "We have developed a product that can change the medical standard of treating this disease. The placement and share plan provide the necessary working capital for the marketing to match the quality of the product."

At the time of writing, shares in Cellestis were trading strongly at $3.55, up more than 11 per cent on last week's price.