Ariosa Matches Sequenom-Illumina with NIPT LDT Licensing Move

Following the agreement between Sequenom and Illumina earlier this year allowing the latter to license pooled non-invasive prenatal testing (NIPT) IP to third-party labs worldwide, Roche Diagnostics’ Ariosa Diagnostics announced this week that it would grant licenses to labs for its own technology relating to NIPT. The three major players in prenatal testing operate their own labs to perform NIPT services on sent-out samples, but have encouraged outside labs to adopt their technologies in order to expand their market reach.  

Ariosa (Roche), Verinata (Illumina) and Sequenom offer maternal blood sample NIPTs as laboratory developed tests (LDTs) that do not require regulatory approval as in vitro diagnostic (IVD) products. While the companies aspire to bring NIPT test kits to the market, they are more immediately pursuing market development through the collection of licensing fees or other payments from client labs. The Sequenom-Illumina agreement and licensing program begun by Ariosa represent one phase of industry strategy; Illumina and Ariosa look to release either FDA-approved or CE-marked NIPT test kits in coming years.

For more information regarding this fast-growing market, please consult Kalorama Information’s 2015 market research report The Market for Prenatal, Newborn and Carrier Genetic Testing.