NEW YORK (GenomeWeb News) – Artemis Health today said that it has licensed co-exclusive worldwide rights from Stanford University to develop cell-free fetal DNA prenatal diagnostic tests based on research carried out in the lab of Stephen Quake.
Menlo Park, Calif.-based Artemis said that the licensing deal will expand its clinical and research program and allow it to develop a non-invasive prenatal blood test that predicts chromosomal and genetic disorders. The privately held firm, which was formed in 2002, has a parallel development program focused on the isolation of intact fetal cells from maternal blood for advanced genetic analysis.
Artemis President and CEO Lissa Goldenstein told GenomeWeb Daily News today that the firm is developing tests based on both methodologies. "We were originally focused on the intact fetal cell, and we continue making progress along that path," she said. "But the Quake opportunity allows us to really broaden our research to include both the intact fetal cell and cell-free fetal DNA."
The license from Stanford covers the use of digital PCR and shotgun sequencing to analyze cell-free fetal DNA from maternal blood, particularly for the diagnosis of fetal genetic disorders, such as Down syndrome, Edwards syndrome, and Patau syndrome. Artemis also noted that it has extended its exclusive consulting relationship with Quake.
Goldenstein said that Artemis plans to initially launch products as laboratory developed tests while in parallel working toward Food and Drug Administration clearance. "We feel very confident that we'll have some study data within the next 12 months" that will prove the test is effective, and a commercial launch will follow, she said.
Quake's approach was detailed in a paper appearing in the Proceedings of the National Academy of Sciences in early October. The researchers used digital PCR and shotgun sequencing to sequence all of the cell-free DNA in the mother's blood plasma.
Though Quake's team used Illumina's Genome Analyzer to sequence a mixture of maternal and fetal DNA fragments, Artemis does not have a preference for which technology is used for the back end of the testing process.
The firm was initially founded based on microfluidics technology that was developed at Massachusetts General Hospital and Harvard University. It uses the technology to separate out the maternal cells without hurting the fetal cells, explained Goldenstein.
"However, other than that, we are technology agnostic," she said. "Our focus is on using the best technology on the market today and in the future to get these tests to women and their physicians. So, we are not locked into any hardware platform."
Quake has applied for a patent on the methodology outlined in the paper and has also licensed the IP to Fluidigm. In addition, he is a co-founder of Fluidigm and the chair of that company's scientific advisory board.
A similar method of prenatal screening has been employed by Sequenom in collaboration with researchers from the Chinese University of Hong Kong, which demonstrated that they could use massively parallel DNA sequencing to detect Down syndrome from cell-free fetal DNA in pregnant women’s blood. Their findings were published in the Proceedings of the National Academy of Sciences in early December.
Sequenom is currently conducting studies on its SEQureDx test, which uses its mass spectrometry platform to diagnose trisomy 21 from fetal RNA in maternal blood. The firm hopes to commercialize that test this year.
Asked whether there are any concerns about a potential intellectual property dispute, Goldenstein said, "We've carefully reviewed the IP around all of our approaches and technology platforms that would be needed to take it to market, and we are confident that have all of the IP protection we would need to be able to take this to market."
Alloy Ventures, Mohr Davidow Ventures, and Sutter Hill Ventures are among Artemis' venture capital backers, and Goldenstein said the firm doesn't see financing as a limitation to getting the tests to market. She also said the firm may partner with some of the larger lab companies, regional labs, and hospital labs to cast a wide distribution net once it receives FDA clearance.