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GATC Subsidiary LifeCodexx to Develop Prenatal Dx Based on Next-Gen Sequencing

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By Julia Karow

This article, originally published April 28, has been updated to include comments from LifeCodexx CEO Michael Lutz.

LifeCodexx, a new player in the sequencing diagnostics market, is developing clinically validated diagnostic tests that use next-generation sequencing, the company said last week.

With a handful of employees, the firm, a subsidiary of German genomic service provider GATC Biotech, is initially focusing on prenatal diagnostics for the European market.

LifeCodexx, which recently hired former Cogenics global general manager and Epidauros CEO Michael Lutz as its chief executive, is using GATC's sequencing laboratory and expertise. GATC holds a majority stake in the firm, which also has individual private investors and has been awarded up to €300,000 ($400,000) in funding from two German government programs.

According to Lutz, the company is currently working on an undisclosed non-invasive prenatal diagnostic test, using the "suite of instruments" available at GATC, which has next-gen sequencers from 454 and Illumina.

He said LifeCodexx has developed a method that allows researchers to distinguish between parental and fetal DNA, which it is currently validating for its lead test using clinical samples. In the second half of the year, the company plans to start a broader clinical validation, involving a couple of hundred samples.

Lutz said there are no competing tests on the market right now, but several are in development by others. "There are significant unmet needs to develop non-invasive methods," he said. "We have started working on other tests, using the same methodology, but for now, we have one test that we are really focusing on in order to get the clinical trial under way." A test for Down syndrome, he said, "is certainly an obvious one."

Indeed, almost two years ago, a group led by researchers at Sequenom and the Chinese University of Hong Kong published a paper describing the use of next-gen sequencing to analyze maternal and fetal DNA in blood as a test for Down syndrome.

Another group, led by Stanford University researcher Stephen Quake, published a paper in 2008 describing a similar approach to detect Down syndrome and other trisomies. Both Sequenom and the Stanford team have filed for intellectual property protection for their methods, and Stanford has licensed its IP co-exclusively to Fluidigm and Artemis Health (GWDN 2/12/2008 and IS 1/27/2009).

Lutz said LifeCodexx has applied for IP protection surrounding its method, which it has not yet published. He said the company will initially focus on the European market and is working toward a CE-certified test kit. Marketing the test will require a "stage-wise approach" that will involve getting "key opinion leaders on board."

The time is right for launching a next-gen sequencing diagnostic firm, he said, because as the cost of sequencing drops, it is becoming competitive with other genotyping methods, such as PCR. Unlike those exiting tests, he said, the next-gen sequencing approach can deliver several results "in one shot." Another reason to enter the market now, he said, is to be able to start discussions with potential payors early.

For GATC Biotech, a diagnostics spin-off was a "logical step," according to a company spokeswoman, given the firm's considerable experience with next-generation sequencing from research projects for customers.

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