OREANDA-NEWS. Premaitha Health plc (AIM: NIPT, "Premaitha" or "the Company"), developer of the IONA® test, the first CE-marked non-invasive prenatal screening test (NIPT) has expanded its in-house NIPT screening service by opening a dedicated laboratory which triples clinical capacity in response to demand for the IONA® test from clinicians.

The new Care Quality Commission (CQC)-accredited, clinical laboratory which is based at Premaitha's headquarters on Manchester Science Park, will enable Premaitha to dramatically increase throughput, of the maternal blood samples analysed each month using the IONA® test.

The IONA® test estimates the risk of a fetus being affected by Down's syndrome and other serious genetic conditions such as Patau's syndrome and Edwards' syndrome by analysing cell-free DNA from a sample of maternal blood. The test is more sensitive and specific than the current combined test available and provides a more accurate and reliable screening result within three to five days, compared to the lead time of up to 14 days offered by US and China-based NIPT service laboratories.

Premaitha began offering an NIPT clinical laboratory service on a smaller scale in July 2015 to allow new customers to provide pregnant women with access to the IONA® test as soon as possible, during the set-up of their own lab or while they grow their NIPT volumes. The service also provides an important back-up option during busy periods, ensuring results are delivered to healthcare professionals on-time and from a regulated and trusted clinical laboratory.

Since initiating the in-house service, the Company has seen demand for the IONA® test increase significantly with service laboratory customers from across the UK and internationally. Premaitha also provides its customers with advice and support in the logistics of shipping blood samples in a cost-effective, safe, compliant and rapid manner.

Barry Hextall, CFO of Premaitha said: "The decision to expand our NIPT in-house service has been driven by demand from clinicians for the fast, accurate and accredited results provided by the IONA® test. These additional laboratory facilities and our extended team of specialists who run the IONA® test service means we can offer the benefits of the first and only CE-marked in-vitro diagnostic product for NIPT to more pregnant women, sooner.  This also fulfils one of the commercialisation objectives stated at the time of the recent fundraising."