Life Technologies Corporation, a global biotechnology company, has acquired Pinpoint Genomics, Inc., and its early-stage non-small cell lung cancer test that can help doctors identify those early-stage patients at high risk for progression to late-stage disease. Lung cancer is currently the leading cause of cancer deaths worldwide, claiming close to 1.5 million lives every year.
"Although we've realized impressive gains against many forms of cancer, the survival rate for lung cancer hasn't changed in 30 years," said Ronnie Andrews, president of medical sciences at Life Technologies. "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 tumour 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," said Michael Mann, MD, 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 I and II many patients who have been cured by surgery with patients who will recur and die. As a result, many stage II 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 I 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," said David Jablons, MD, chief of general thoracic surgery at the University of California, San Francisco, who helped co-found Pinpoint Genomics with Dr 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 rigorously 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 tumour specimens, this quantitative PCR lab-developed test (LDT) measures expression of a proprietary 14-gene panel. Results of the blinded studies, which demonstrated the test's clinical validity and utility, were published in the highly-regarded medical journal, The Lancet.
"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," said Dr Jablons.
"We see an opportunity in lung cancer to change the treatment paradigm with more effective diagnostics," said Gregory T Lucier, chairman and chief executive officer of Life Technologies. "As Life Technologies moves further into the diagnostics space, we will focus on tests that have strong clinical utility where there is a large unmet need."
Life Technologies possesses a breadth of platforms that can be leveraged in the development of new diagnostics, including next-generation sequencing, Sanger sequencing, qPCR and proteomics. The company is actively working to drive the development of diagnostic content across multiple platforms, as evidenced by a companion diagnostic agreement with GlaxoSmithKline, a test development partnership with Gen-Probe, and recently announced collaborations with Boston Children's Hospital and the Hospital for Sick Children in Toronto, to develop the company's next-generation sequencers for clinical research in pediatric diseases.
"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," said Andrews. "Life Technologies intends to pursue In Vitro Diagnostic certification outside of the United States, so the test can be broadly deployed on the company's regulated platforms including the 7500 Fast Dx for qPCR."
"With the physician and patient portal acquired from Navigenics, Life Technologies is positioned to create a new standard of excellence in the communication of complex diagnostic results," said Andrews. "In addition, with the emergence of the Ion Personal Genome Machine (PGM) Dx for next-generation sequencing as a technology ready for clinical development, Life stands alone in our industry as a company that can empower labs with content and platforms across the genome, transcriptome and proteome."
This acquisition represents another step in the company's strategy to develop its diagnostic business through internal development, partnerships and select acquisitions. The company expects the combination of the Pinpoint transaction, and acquisition of Navigenics, to be $0.02 dilutive to Life Technologies earnings in 2012, $0.05 dilutive in 2013 and accretive thereafter. The company also expects the combination to meet its stated criteria for evaluating smaller acquisitions and therefore to be accretive to the company's overall ROIC within three years following the close of the transactions.
Life Technologies Corporation is a global biotechnology company with customers in more than 160 countries using its innovative solutions to solve some of today's most difficult scientific challenges.