Premaitha: New laboratory to meet demand for IONA test service

Premaitha Health plc, 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, said the company in statement issued on Wednesday.

Premaitha says that 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.

According to the company, since initiating the in-house service, it 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.”