Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Study Examines Relationship Between Cellular Metabolism, DNA Damage Repair

A new study in Molecular Systems Biology finds that an antioxidant enzyme shifts from mitochondria to the nucleus as part of the DNA damage response.

Stem Cell Systems Targets Metastatic Melanoma in Mouse Model

Researchers in Science Translational Medicine describe a pair of stem cell systems aimed at boosting immune responses against metastatic melanoma in the brain.

Open Pediatric Brain Tumor Atlas Team Introduces Genomic Data Collection, Analytical Tools

A study in Cell Genomics outlines open-source methods being used to analyze and translate whole-genome, exome, and RNA sequence data from the Pediatric Brain Tumor Atlas.

Neurological Outcomes Linked to Innate Immune Features After Cardiac Arrest

Researchers reporting in Med dig into immune features found a few hours after cardiac arrest that correspond with neurological outcomes.