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NGS Will Play Minor Role Initially in Tests Offered Through Life Tech's New Navigenics CLIA Lab

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Not next-generation sequencing but qPCR will be used initially in tests Life Technologies plans to develop in the CLIA lab it obtained through its acquisition of Navigenics.

As part of its strategy to build out its molecular diagnostics business, Life Technologies acquired the company this week for an undisclosed amount.

Through its Health Compass genetic analysis services, Navigenics, which was founded in 2006 as a direct-to-consumer genomic testing company, has been providing "clinically actionable, personalized genetic insights about disease risk and medication response to catalyze behavior change and inform clinical decision-making," according to the firm.

Life Tech purchased the company in order to obtain a CLIA laboratory and to gain access to a physician portal to interpret the results of genomic tests.

Navigenics' CLIA laboratory is licensed in all 50 US states. Life Tech plans to use the lab to design and validate new diagnostic assays, for example lab-developed cancer tests "that we know today can have an impact" on diagnostics and therapy selection, said Ronnie Andrews, Life Tech's president of medical sciences. In addition, the lab will offers services to pharmaceutical partners.

The first tests will focus on molecular subclasses of lung, ovarian, and prostate cancer and will provide information on treatment options or help to monitor drug efficacy, Andrews said during a press conference at the American Association for Clinical Chemistry Annual Meeting in Los Angeles this week.

The tests will run on a qPCR platform in the US, but the plan is to move them to the Ion Torrent PGM outside the United States.

Andrews was cautious, though, about the use of next-gen sequencing in the near future. "Next-gen sequencing is not yet ready for the clinic," he said. "It won't be ready for the standard of care for three to five years."

While Ion Torrent's technology "will be disruptive," it is "ahead of our ability to take sequences and pressure-test them against well-curated data sets" in order to interpret the results, he said.

A number of academic centers are already applying next-gen sequencing in cancer diagnostics, but Andrews said that "no 300-bed hospital is going to do that" because it does not know what to do with the data. For most cancer patients with first or second stage disease, "you don't need the full sequence," he said.

Navigenics is the first in a series of "small, tuck-in acquisitions" Life Tech is planning over the next two to three months, he said, that will "allow us to immediately address unmet medical needs," for example in oncology, inherited disease, infectious disease, transplant medicine, and neurology.

Bernadette Toner reported for this article from the AACC Annual Meeting in Los Angeles.

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