NEW YORK (GenomeWeb News) – Life Technologies said today that it has acquired Pinpoint Genomics and its early-stage non-small cell lung cancer test designed to help doctors identify early-stage patients at high risk for progression to late-stage disease.
Financial terms of the acquisition were not disclosed.
Mountain View, Calif.-based Pinpoint developed the NSCLC assay in its CLIA-certified laboratory and validated the test in two independent, blinded retrospective studies of more than 1,500 patients, work that was published earlier this year in The Lancet.
The laboratory-developed test uses quantitative PCR to measure expression of a proprietary 14-gene panel using formalin-fixed, paraffin-embedded tumor specimens.
Life Tech said that Pinpoint's test is the first commercial assay that has been rigorously validated in large-scale, independent studies to reliably predict the risk of death for early stage lung cancer patients.
Ronnie Andrews, president of medical sciences at Life Technologies, noted in a statement that "the survival rate for lung cancer hasn't changed in 30 years," and that "half of the early-stage patients don't survive beyond five years, a situation that could benefit from more accurate prognosis and more efficient treatment protocols."
Lung cancer is currently diagnosed and staged by a combination of tumor size, location, and the extent of spread to lymph nodes. The current standard of care for most stage I disease is surgery followed by monitoring, otherwise known as "watchful waiting." The National Comprehensive Cancer Network recommends that both Stage II and the highest risk Stage IB patients be treated with adjuvant chemotherapy.
"Data from the Pinpoint assay will fill a gap of insufficient prognostic information, and help physicians and their early-stage patients, who face very difficult decisions regarding post-operative therapy, to make better, individualized plans," Michael Mann, an associate professor of cardiothoracic surgery at the University of California, San Francisco, and a co-founder of Pinpoint Genomics, said in a statement. "It should therefore facilitate more effective implementation of current guidelines."
Andrews said that the test was developed and will be run at Pinpoint's laboratory on Life Tech's qPCR platform, the 7500 Fast Dx. As such, in addition, to offering an LDT in the US, Life Tech will pursue in vitro diagnostic certification outside the US in order to offer the test using its global installed base of the 7500 Fast Dx instrument, he noted.
Life Tech said that the acquisition represents another step in its strategy to develop its diagnostic business through internal development, partnerships, and select acquisitions. Last week, Life Tech announced that it had acquired consumer genetic testing firm Navigenics, which provided Life Tech with its first CLIA-certified laboratory.
Life Tech has also established a companion diagnostic agreement with GlaxoSmithKline; a test development partnership with Gen-Probe; and collaborations with Boston Children's Hospital and the Hospital for Sick Children in Toronto to develop its next-generation sequencers for clinical research in pediatric diseases.
Life Tech said that it expects the combination of the Pinpoint and Navigenics transactions to be $0.02 dilutive to earnings in 2012; $0.05 dilutive in 2013; and accretive thereafter.