Fluidigm Corporation today announced that it has secured co-exclusive licenses to Stanford University inventions that detect fetal genetic characteristics in maternal plasma, including the use of a combination of digital PCR* and high-throughput sequencing.

These licenses specifically cover a technique announced by a group of Stanford researchers several months ago that counted chromosomes by finding trace amounts of fetal DNA in a pregnant woman’s blood. The paper — Noninvasive Diagnosis of Fetal Aneuploidy by Shotgun Sequencing DNA from Maternal Blood — was published in the October 6, 2008 issue of the Proceedings of the National Academy of Sciences. Because small amounts of fetal DNA are present in maternal blood quite early in pregnancy, researchers believe this technique can provide a much earlier and safer diagnosis for fetal aneuploidy than is now available.

“The research that combines Fluidigm’s digital PCR technology and high-throughput sequencing is a breakthrough in the quest for a non-invasive means of diagnosing fetal aneuploidy,” said Gajus Worthington, Fluidigm President and CEO. “By combining these technologies, the researchers were able to detect over-representation of chromosomes from the fetus.”

The licenses specifically cover Stanford University inventions relating to:

Non-invasive Fetal Genetic Screening by Digital Analysis; Noninvasive Diagnosis of Fetal Aneuploidy by Sequencing; and Digital PCR Enables Rapid Prenatal Diagnosis of Fetal Aneuploidy.

In an earlier Stanford University press release, Stephen Quake**, PhD, professor of bioengineering and the study’s senior author said, “This technique is on the leading edge of a flood of different ways that rapid DNA sequencing will be used in medicine. Non-invasive testing will be much safer than current approaches.”

Researchers used Fluidigm’s integrated fluidic circuits (IFCs) to count individual molecules — using the company’s digital PCR technology — to set the exact parameters for sequencing steps that helped determine the amounts of critical fetal DNA.

Fluidigm is the only company today offering a commercially proven digital PCR system. The company’s BioMark™ Digital Array is an IFC designed specifically for digital PCR. This chip partitions a sample premixed with PCR reagents into 765 replicate reactions, thus allowing the absolute quantification of target sequences. Digital arrays transform digital PCR into a straightforward approach for PCR applications demanding extreme accuracy of copy number. In contrast, when performed on traditional technologies such as microwell plates or assays, digital PCR has proven to be an impractical technique.