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Illumina Sues Premaitha Health Over NIPT IP; Swiss Firm Adopts Premaitha's Iona CE-IVD Test

NEW YORK (GenomeWeb) – Illumina and its wholly-owned subsidiary Verinata Health have filed a patent infringement suit against Premaitha Health over IP relating to non-invasive prenatal testing, the companies said today.

The suit, filed in the High Court of Justice, Chancery Division, Patents Court in the UK, asserts European Patent (UK) 0 994 963 B2 and European Patent (UK) 1 981 995 B1, both relating to the use of cell-free fetal DNA for NIPT.

Illumina licenses the patents exclusively from Sequenom and Stanford University. Stanford joined the suit because it is the registered owner of the '995 B1 patent.

In the suit, the plaintiffs claim that Premaitha's Iona test infringes the patents, including its use of next-generation sequencing to analyze cell-free fetal DNA from maternal blood. They seek "all available remedies," including damages and injunctive relief.

UK-based Premaitha launched the Iona test, which assesses the risk of carrying a fetus with trisomy 21, 18, or 13 early in pregnancy, as a CE-marked in vitro diagnostic product in Europe last month.

Illumina Senior Vice President and General Counsel Charles Dadswell said in a statement that Illumina filed the suit to "actively defend" its IP rights. "We will also continue to monitor the NIPT field and file patent suits where appropriate when our patents are infringed," he added.

Premaitha said in a statement that its directors believe the Iona test does not infringe the patents as claimed by Illumina.

In a separate announcement, Premaitha said today that it has signed an agreement with Esperite of the Netherlands under which Esperite's Swiss subsidiary Genoma will have the right to use the Iona test and apply the CE-IVD marking to perform its own NIPT service, called Tranquility.

Genoma plans to run the Tranquility test in its Geneva laboratories, using Premaitha's technology.

Premaitha CEO Stephen Little said in a statement that the agreement is "a major milestone" for the company, marking its first sale in Europe. "Genoma has the strength of infrastructure and the high technical expertise to be able to accelerate the broad dissemination of NIPT in Europe," he said.