Commercial partnership for laboratory-developed diagnostic is Sequenom’s first for non-U.S. markets.

Sequenom and the GATC subsidiary LifeCodexx inked a licensing agreement to develop and commercialize prenatal laboratory testing services in Europe. The partnership will initially focus on a trisomy 21 test, and other aneupoloidy tests for German-speaking European regions including Germany, Austria, Switzerland, and Liechtenstein. Launch of the tests in other countries may also be considered.

The assay is based on the the sequencing of circulating cell-free fetal DNA in maternal plasma. Under terms of the deal LifeCodexx has been granted licenses to key patents and IP and will pay Sequenom an up front fee, along with minimum annual royalty payments, and royalties based on sales of testing services.

The deal represents Sequenom’s first European commercial partnership in noninvasive prenatal diagnostics. “This agreement enables us to extend the licensing rights to our proprietary testing modality internationally,” comments Harry F. Hixson, chairman and CEO at Sequenom. “This is the first of our ex-U.S. licensing agreements that enables a partner to commercialize a trisomy 21 laboratory developed test, another step in bringing this test to market and in achieving our corporate goals.”  

Sequenom’s SEQureDxTM technology is based on the isolation and analysis of circulating cell-free fetal nucleic acid from a maternal blood sample and is ideally suited to the development of noninvasive tests for fetal gene and chromosome abnormalities such as aneuploidies, Sequenom claims. The technology was originally developed by Professor Dennis Lo at The Chinese University of Hong Kong.

Last month Sequenom announced a deal to purchase Illumina’s sequencing equipment and consumables for use in development of the trisomy 21 test. On announcing this deal Sequenom said the firms will work together toward the submission for regulatory approval of an in vitro diagnostic product for the detection of fetal chromosomal abnormalities.

Established in 2010 by GATC, LifeCodexx is exploiting its next-generation sequencing expertise to develop clinically validated molecular assays in the field of prenatal diagnostics. In June the firm announced the start of clinical validation studies with the maternal blood-based trisomy 21 test carried out on the Illumina HiSeq 2000 system.

The method had previously been validated on the Illumina platform, and about 500 maternal samples will be included in the clinical validation study. LifeCodexx says it expects the test will be ready for launch by the end of 2011.

Commenting on the Sequenom licensing deal, LifeCodexx CEO Michael Lutz, Ph.D., remarks, “building upon our recently initiated clinical validation study for our trisomy 21 test, this agreement is another key milestone with respect to our goal of launching our first test by late 2011.

“We are now in a strong position to exploit the clinical utility and proprietary science behind the noninvasive detection of trisomy 21 and eventually other aneuploidies using shotgun sequencing as initially developed by Dr. Dennis Lo and his team.”

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