Change of Life
September 2012
by Lloyd Dunlap  |  Email the author


CARLSBAD, Calif.—Life Technologies Corp. has acquired Pinpoint Genomics Inc. and its early-stage non-small cell lung cancer test that can help doctors identify early-stage patients at high risk for progression to late-stage disease.
"Life Technologies is uniquely positioned to enter the diagnostics space because of our breadth of platforms that can be leveraged in the development of new diagnostics," says Ronnie Andrews, president of medical sciences at Life Technologies. "These platforms span both genetic and proteomic analysis, including next-generation sequencing, Sanger sequencing, qPCR, flow cytometry and immunohistochemistry. In addition, we recently announced that the Ion Torrent Personal Genome Machine (PGM) will be developed for proteomics capabilities. We don't believe another company can offer this breadth of analytic ability across genome, transcriptome and proteome."   

Although we've realized impressive gains against many forms of cancer, the survival rate for lung cancer hasn't changed in 30 years, notes Andrews.
"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," he says.
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 1 disease is surgery followed by monitoring, otherwise known as "watchful waiting." The National Comprehensive Cancer Network recommends that both stage 2 and the highest risk stage 1B 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," says Dr. Michael Mann, an associate professor of cardiothoracic surgery at the University of California, San Francisco and a co-founder of Pinpoint Genomics. "It should therefore facilitate more effective implementation of current guidelines."
The problem, he explains, is that conventional staging continues to group together in both stages 1 and 2 many patients who have been cured by surgery with patients who will recur and die. As a result, many stage 2 patients forgo chemotherapy in the hope that they are in the former group; to date, there has been no validated method of identifying the highest-risk stage 1 patients for whom chemotherapy is recommended.

"Some patients who don't need them receive highly toxic chemotherapeutic drugs, while others die without receiving potentially life-saving intervention simply because their risk of progression couldn't be predicted," says Dr. David Jablons, chief of general thoracic surgery at the University of California, San Francisco, who helped co-found Pinpoint Genomics with Mann. "Physicians need molecular tools that accurately identify true high-risk patients."  
The Pinpoint Genomics' laboratory acquired by Life Technologies is the first to market an application that has been validated in large-scale, independent studies to reliably predict the risk of death for early-stage lung cancer patients. The test was developed in Pinpoint's CLIA-certified environment and validated through two independent, blinded retrospective studies involving approximately 1,500 patients. Using formalin-fixed, paraffin-embedded tumor specimens, this quantitative PCR lab-developed test (LDT) measures expression of a proprietary 14-gene panel. Results of the blinded studies demonstrated the test's clinical validity and utility and were published in The Lancet. In the two cohorts studied, five-year overall survival rates were 71 to 74 percent in the low-risk group, 57 to 58 percent in the intermediate-risk group and 44 to 49 percent in the high-risk population.  
"By ordering the Pinpoint test, doctors will be able to identify which patients have a high chance of death after surgery, so they can be aggressive and treat those patients immediately for disease and save lives," says Jablons.
Treating disease early is also likely to be economical as better utilization of chemotherapy can eliminate the need for late-stage, extended therapies.  
"Our primary objective for entering the clinical space is to help transform cancer from a deadly disease to a chronic disorder," says Andrews. "As genome sequencing and other molecular technologies mature, we will see a payoff from our societal investment in biological research—namely, the ability to accurately diagnose tumors on a genetic basis and utilize that information in combination with bioinformatics to support clinicians design optimum treatment protocols, and monitor disease recurrence. Life Technologies' strategy will be to seek unmet clinical needs in diagnostics for which we believe our technologies and platforms offer unique benefit. Since the test was developed and will be run in the Pinpoint laboratory on Life's qPCR platform, in addition to offering an LDT in the United States, we will be able to leverage our existing global installed qPCR platforms, which are currently being utilized in a significant number of clinical labs outside of this country."

Life Technologies collaborates with NYGC  
NEW YORK—In early August, the New York Genome Center (NYGC) announced the launch of its Innovation Center, which will provide access to new sequencing technologies and foster collaboration among NYGC's Institutional Founding Members (IFMs) and technology collaborators. Under an agreement with Life Technologies, the first technology the Innovation Center is adopting is the Ion Proton Sequencer, which is designed to sequence an entire human genome in just a few hours for under $1,000. Four Ion Protons will be housed at IFM Memorial Sloan-Kettering Cancer Center.  
The NYGC has allocated capital and operational budgets to its Innovation Center to fund purchases of "next-next generation" sequencing technology, which will allow NYGC and IFM scientists to test and publish on these technologies. This "lab-within-a-lab" will provide the latest technologies to IFMs while minimizing cost and risk, create a vibrant community of users that will help shape future sequencing technologies and applications, and establish thought leadership through early publications, according to the NYGC.
NYGC and IFM scientists will be among the first laboratories to receive and validate the Ion Proton, a new prior to its expected commercial release. Although four Ion Protons are scheduled to be delivered to Memorial Sloan-Kettering Cancer Center, all data from the results of the technology validation will be shared among the IFMs.
"We are pleased that the New York Genome Center has joined a growing list of prestigious, research- focused hospitals, and institutions around the world that are rapidly adopting our Ion semiconductor sequencing technology," said Mark Stevenson, president and chief operating officer of Life Technologies, in a statement. "Like our other customers, we believe NYGC will benefit from this disruptive technology by being able to rapidly generate accurate genomic data quickly and apply it to human disease research."
Code: E091204

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