Biotech firm’s IONA Test ‘could net billions’

BIOTECH firm Premaitha Health is on the verge of tapping into a multi-billion pound market with its ground breaking non-invasive prenatal screening test for pregnant women.

Chief executive of the Manchester-based company, Dr Stephen Little, told there was already strong demand for the newly-developed IONA test, which detects the risk of Downes Syndrome and other serious genetic diseases in unborn babies.

Little launched the company in 2013, after his previous company DxS was sold to QIAGEN BV in 2009 for £85m. He was free to invested in the development of the IONA test.

“We weren’t making money, but we were developing a product,” he said. “Now it’s there and available. We’re using it. Tests are getting done.
This is only in the last couple of months, but it’s all happening now.

“Up until the back end of last year, we were effectively a development company. Now we are a sales and marketing company.”

Meanwhile, Little’s company based at Manchester Science Park, is having to fight a legal defence and lodge a counter claim in the High Court for alleged infringement of patents from US company Illumina and its subsidiary Verinata Health over the IONA.

But Little, who employs 40 people at Premaitha, is unfazed by impending legal battle.

“They’re doing the same sort of thing as us,” he said. “These methods have been around for quite a long time and I’m sure they would like to own them.

“We’re ahead of them – we’ve got a product to market and they haven’t. We’ve got a lot of traction. They’ve got a test in America, but in terms of Europe, we’re leading the charge.

“So if you were a great big American corporation and there was a small British company that was beating you in the market and you had some IP (intellectual property) that you could maybe use, that’s what you would do. It was no surprise because they are an aggressive company.”

No surprise either, because the new test promises 99.9% accuracy, unlike the existing test currently available to all pregnant women, as Little explained.

“It’s performance figures are about 90% detection and about 5% false positive,” he said. “90% detection means that for every 10 Downes babies you’ll miss one.

“The 5% false positive rate means that for every 25 women who the test says are at risk, one of them is really at risk and 24 of them have been falsely identified by the test.

“All 25 of those women are told you’re at high risk. So we say you’d better go off for amniocentesis. The mothers and the fathers don’t like it. It’s a needle in the stomach there’s a risk to the fetus. I don’t want to scare people, but it’s not nothing – about 1%. And there is a risk of spontaneous termination after procedure.

“There is a big demand for the IONA screening test because the accuracy of the current screening test isn’t good enough.

“The benefit IONA test is that its detection rate is about 99.9% and its false positive rate is less than 0.1%. To be honest, we’ve had not false positives and no false negatives so far, but there will be some in there.

“It means that when we tell woman she’s at high risk, she really is at high risk.

“It’s not a perfect screening test, but it’s so much better than what’s gone on before.

“Not surprisingly, there is a huge demand for the test. It’s reckoned the market will be somewhere between $4 and $8bn in a few years’ time.”