Biotech firm’s prenatal test breakthrough in Russia

PIONEERING Manchester medical diagnostics company Premaitha Health has signed an exclusive Russia distribution agreement for its flagship IONA test – the CE marked non-invasive prenatal screening test.

The deal has been struck with GeNext LLC, a company dedicated to providing high quality molecular diagnostic products and will open up a key new market for Premaitha.

Due to its highly accurate detection, the IONA test significantly reduces the number of women who are unnecessarily subjected to risky, invasive follow-up procedures to diagnose Down’s Syndrome and other genetic conditions.

There are approximately two million pregnancies per annum in Russia, and the agreement with GeNext will enable the women to access non-invasive prenatal testing (‘NIPT’) through the test.

As part of the agreement, GeNext will establish a central laboratory to act as a regional hub to process samples. In the interim period, GeNext will send samples to Premaitha’s Manchester laboratory to be processed.

“We are delighted to have signed this agreement with GeNext to provide the IONA test in Russia,” said Premaitha chief executive Dr Stephen Little.

“This is a new territory for Premaitha and it enables us to establish a local laboratory offering routine non-invasive prenatal screening.

“The IONA test is the leading CE marked complete system for NIPT, allowing a decentralised strategy with more labs being able to offer NIPT in-house with a regulated and validated system. 

“With the signing of this latest agreement, Premaitha is demonstrating its ability to develop a network of partners servicing many countries across the globe.

“The Russian market has significant potential for the IONA test and, through GeNext, we are extremely well placed to accelerate market penetration across the country as awareness of the benefits of the test continues to grow.”

GeNext chief executive Vitali Proutski said: “This is an extremely important alliance for GeNext, as there is compelling clinical evidence to support the benefits of NIPT, and we believe Premaitha’s IONA system is the market leading product. We have built up significant expertise in the distribution of molecular diagnostics and the inclusion of the IONA® test within our portfolio will significantly enhance our offering.”

The deal follows other major breakthroughs for the IONA test, including deals to offer the service in Eastern Europe and India and the recommendation by the UK’s National Screening Committee that the test should be routinely offered to the NHS.

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