Change of Life

Life Technologies acquires Pinpoint Genomics and CLIA-approved lung cancer test

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CARLSBAD, Calif.—Life Technologies Corp. has acquiredPinpoint Genomics Inc. and its early-stage non-small cell lung cancer test thatcan help doctors identify early-stage patients at high risk for progression tolate-stage disease.
"Life Technologies is uniquely positioned to enter thediagnostics space because of our breadth of platforms that can be leveraged inthe development of new diagnostics," says Ronnie Andrews, president of medicalsciences at Life Technologies. "These platforms span both genetic and proteomicanalysis, including next-generation sequencing, Sanger sequencing, qPCR, flowcytometry and immunohistochemistry. In addition, we recently announced that theIon Torrent Personal Genome Machine (PGM) will be developed for proteomicscapabilities. We don't believe another company can offer this breadth ofanalytic ability across genome, transcriptome and proteome."

Although we've realized impressive gains against many formsof cancer, the survival rate for lung cancer hasn't changed in 30 years, notesAndrews.
"Half of the early-stage patients don't survive beyond fiveyears, a situation that could benefit from more accurate prognosis and moreefficient treatment protocols," he says.
Lung cancer is currently diagnosed and staged by acombination 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 bymonitoring, otherwise known as "watchful waiting." The National ComprehensiveCancer Network recommends that both stage 2 and the highest risk stage 1Bpatients be treated with adjuvant chemotherapy.
"Data from the Pinpoint assay will fill a gap ofinsufficient prognostic information, and help physicians and their early-stagepatients who face very difficult decisions regarding post-operative therapy tomake better, individualized plans," says Dr. Michael Mann, an associateprofessor of cardiothoracic surgery at the University of California, SanFrancisco and a co-founder of Pinpoint Genomics. "It should thereforefacilitate more effective implementation of current guidelines."
The problem, he explains, is that conventional stagingcontinues to group together in both stages 1 and 2 many patients who have beencured by surgery with patients who will recur and die. As a result, many stage2 patients forgo chemotherapy in the hope that they are in the former group; todate, there has been no validated method of identifying the highest-risk stage1 patients for whom chemotherapy is recommended.

"Some patients who don't need them receive highly toxicchemotherapeutic drugs, while others die without receiving potentiallylife-saving intervention simply because their risk of progression couldn't bepredicted," says Dr. David Jablons, chief of general thoracic surgery at theUniversity of California, San Francisco, who helped co-found Pinpoint Genomicswith Mann. "Physicians need molecular tools that accurately identify truehigh-risk patients."
The Pinpoint Genomics' laboratory acquired by LifeTechnologies is the first to market an application that has been validated inlarge-scale, independent studies to reliably predict the risk of death forearly-stage lung cancer patients. The test was developed in Pinpoint'sCLIA-certified environment and validated through two independent, blindedretrospective 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 theblinded studies demonstrated the test's clinical validity and utility and werepublished in The Lancet. In the twocohorts studied, five-year overall survival rates were 71 to 74 percent in thelow-risk group, 57 to 58 percent in the intermediate-risk group and 44 to 49percent in the high-risk population.
"By ordering the Pinpoint test, doctors will be able toidentify which patients have a high chance of death after surgery, so they canbe aggressive and treat those patients immediately for disease and save lives,"says Jablons.
Treating disease early is also likely to be economical asbetter utilization of chemotherapy can eliminate the need for late-stage,extended therapies.
"Our primary objective for entering the clinical space is tohelp transform cancer from a deadly disease to a chronic disorder," saysAndrews. "As genome sequencing and other molecular technologies mature, we willsee a payoff from our societal investment in biological research—namely, theability to accurately diagnose tumors on a genetic basis and utilize thatinformation in combination with bioinformatics to support clinicians designoptimum treatment protocols, and monitor disease recurrence. Life Technologies'strategy will be to seek unmet clinical needs in diagnostics for which webelieve our technologies and platforms offer unique benefit. Since the test wasdeveloped 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 toleverage our existing global installed qPCR platforms, which are currentlybeing utilized in a significant number of clinical labs outside of thiscountry."

Life Technologiescollaborates 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 newsequencing technologies and foster collaboration among NYGC's InstitutionalFounding Members (IFMs) and technology collaborators. Under an agreement withLife Technologies, the first technology the Innovation Center is adopting isthe Ion Proton Sequencer, which is designed to sequence an entire human genomein just a few hours for under $1,000. Four Ion Protons will be housed at IFMMemorial Sloan-Kettering Cancer Center.
The NYGC has allocated capital and operational budgets toits Innovation Center to fund purchases of "next-next generation" sequencingtechnology, which will allow NYGC and IFM scientists to test and publish onthese technologies. This "lab-within-a-lab" will provide the latesttechnologies to IFMs while minimizing cost and risk, create a vibrant communityof users that will help shape future sequencing technologies and applications,and establish thought leadership through early publications, according to theNYGC.
NYGC and IFM scientists will be among the first laboratoriesto receive and validate the Ion Proton, a new prior to its expected commercialrelease. Although four Ion Protons are scheduled to be delivered to MemorialSloan-Kettering Cancer Center, all data from the results of the technologyvalidation will be shared among the IFMs. 
"We are pleased that the New York Genome Center has joined agrowing list of prestigious, research-focused hospitals, and institutionsaround the world that are rapidly adopting our Ion semiconductor sequencingtechnology," said Mark Stevenson, president and chief operating officer of LifeTechnologies, in a statement. "Like our other customers, we believe NYGC willbenefit from this disruptive technology by being able to rapidly generateaccurate genomic data quickly and apply it to human disease research."

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