(Sharecast News) - Molecular diagnostics company Yourgene Health has submitted its CE-marking technical file for the Illumina-based 'IONA' test to its EU notified body, BSI Netherlands, it announced on Monday.
The AIM-traded firm said BSI Netherlands would now audit the technical file, and if accepted, would issue a European CE-marking certificate.
As soon as regulatory approvals were received, the company said it would launch the product across Europe, and pursue further regulatory registrations in newly-addressable markets throughout 2020 and beyond.
It described the IONA test as a non-invasive prenatal test for pregnant women, which estimated the risk of a fetus having Down's syndrome, Edward's syndrome and Patau's Syndrome.
The test, which the company claimed was a "market leader" in terms of accuracy, was carried out on a small blood sample taken from the mother's arm, with no risk of miscarriage.
It was developed as a format compatible with Illumina's "next-generation" sequencing technology.
"We are very excited to bring our IONA test to market on the Illumina platform," said chief executive officer Lyn Rees.
"The launch of the test has been greatly anticipated by our laboratory customers and will be a strong driver of our future growth.
"We look forward to announcing the receipt of our CE-marking certificate and updating shareholders on the plans for commercial launch."
At 1547 GMT, shares in Yourgene Health were up 3% at 15.45p.
10 Mar 2020 15:31
Yourgene Health acquires its French distribution partner
(Sharecast News) - Molecular diagnostics company Yourgene Health announced the acquisition of AGX-DPNI on Tuesday, which it described as a newly-formed entity comprising the NIPT distribution business of AdGeniX - its current French distribution partner for the 'IONA' test.
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