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Fluidigm, Novartis Amend MDx Alliance

By a GenomeWeb Staff Reporter

NEW YORK (GenomeWeb News) – Fluidigm disclosed in a document filed with the US Securities and Exchange Commission on Monday that it and Novartis Vaccines and Diagnostics have amended an agreement for the development of molecular diagnostics based on Fluidigm's digital PCR system.

Under the amended deal, the two firms modified certain development milestones established by an original agreement forged in May 2010. Novartis would pay Fluidigm milestone payments of $3.3 million, up from $3 million. The period of time that Novartis may exercise rights to license technology under the deal have also been modified, though Fluidigm did not elaborate.

The alliance between Fluidigm and Novartis is focused on the development of a microfluidic system with an initial effort on developing a non-invasive prenatal diagnostics test for fetal aneuploidies. In Fluidigm's annual report filed last week, the South San Francisco, Calif.-based firm, which went public in February, said that the platform is in the early stages of development and it has not filed any regulatory submissions with the US Food and Drug Administration and has not determined whether such approval will be required.

In addition to the milestone payments, the May agreement called for a payment of $3 million to Fluidigm upon Novartis exercising its option to license Fluidigm's technology and upon Fluidigm satisfying a specified but undisclosed product development milestone.

Novartis has the option to exclusively license the technology in the primary field of non-invasive testing for fetal aneuploidies, and the "secondary field of non-invasive testing of genetic abnormality, disease, or condition in a fetus, or in a pregnant woman for [Rhesus D] genotyping or carrier status in a pregnant woman, and the genetic carrier status of a prospective mother and her male partner," Fluidigm said in its annual report.

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