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Premaitha NIPT Test Receives ISO Certification

NEW YORK (GenomeWeb) – Premaitha Health today announced it has received ISO 13485:2003 certification for its Iona non-invasive prenatal in vitro diagnostic test from the International Organization for Standardization.

Certification provides a framework for the firm's Iona test to receive the CE mark, which Premaitha expects to happen in February.

"We are making clear progress in achieving the CE mark for the Iona test and its commercial launch," Premaitha CEO Stephen Little said in a statement. "The ISO certification and Annex IV approval provide evidence of the quality of our world-class operational and commercial functions, and we anticipate receipt of the CE-mark very shortly."

The certification recognizes the firm's quality management system as applicable to the design, development, and manufacture of in vitro diagnostic reagents and the associated software for the non-invasive assessment of genetic abnormalities.

The firm has also been audited against the requirements of Annex IV of the In Vitro Diagnostic Medical Device Directive for approval of its quality assurance system.

Premaitha opened a demonstration and training facility at the end of 2014. The firm said in a statement that it has begun commercial manufacturing of the Iona test, and it recently built a new warehouse facility. Both the training center and the warehouse are located at the firm's headquarters in Manchester, UK.

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