NIPT Landscape Shifts in 2014 as Providers Transfer Technology, Plan IVDs

NEW YORK (GenomeWeb) – Noninvasive prenatal testing continued to expand in 2014 and is poised to move from high-risk to average-risk pregnancies in 2015. Last year, a global diagnostic player entered the field, new laboratories in the US and abroad launched NIPT services and several providers announced their plans to develop in vitro diagnostic NIPT kits.

Entering 2015, the landscape of NIPT providers and their alliances has shifted from a year ago. Overall, the global market continues to be dominated by four US-based companies – Sequenom; Illumina; Ariosa Diagnostics, which is in the process of being acquired by Roche; and Natera – as well as two players based in China, BGI and Berry Genomics. Almost all of these currently offer NIPT as laboratory-developed assays, though some have started to transfer their testing technology to other labs and some are working on IVD kits. BGI is the only provider so far to have obtained regulatory approval for its test, from China’s Food and Drug Administration.

New to the scene are LabCorp in the US, which last year launched a NIPT based on Illumina technology, and Premaitha Health, a UK-based firm developing an IVD test. Local diagnostic laboratories in several European countries have started to launch their own tests, in some cases transferring technology from Illumina or BGI. They are joining LifeCodexx, an early NIPT adopter based in Germany.

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