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Following CLIA Lab Buy, Life Tech Jumps into MDx Space with Purchase of Pinpoint, Lung Cancer Dx

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After garnering a CLIA-certified clinical laboratory through its purchase of Navigenics last week, Life Technologies wasted no time jumping into the molecular diagnostics space.

This week, the life sciences tools vendor announced it would acquire Pinpoint Genomics in order to get its hands on a prognostic test that can identify which early-stage non-small cell lung cancer patients are at high risk for experiencing disease progression during the five-year window after surgical resection of their tumors.

Pinpoint's 14-gene expression panel, called the Pinpoint Dx Lung Assay, was developed to run on Life's qPCR technology. The assay works with formalin-fixed, paraffin-embedded tumor samples and analyzes the expression of 11 cancer-related target genes – BAG1, BRCA1, CDC6, CDK2API, ERBB3, FUT3, IL11, LCK, RND3, SH3BGR, WNT3A – and three reference genes – ESD, TBP, YAP1.

The company will launch the panel as a laboratory-developed test in the US through Pinpoint's CLIA-certified lab in Mountain View, Calif., and plans to pursue in vitro diagnostic certification for it outside the US so that it can be run on its regulated platforms, such as its 7500 Fast Dx qPCR system.

Earlier this year, Pinpoint Genomics was getting ready to start reimbursement discussion with payors regarding the multi-gene expression test after two retrospective investigations published in The Lancet showed it "reliably identified" early-stage, non-squamous, non-small cell lung cancer patients at heightened risk of succumbing to their disease after surgery (PGx Reporter 2/15/2012). In the two studies, Pinpoint's test assessed patients' likelihood of disease progression in more than 1,500 patients.

In purchasing Pinpoint, Life Tech gets access to a late-stage molecular diagnostic that it can start selling right away — a strategy that is in line with a broad molecular diagnostic strategy that kicked off with last week's Navigenics acquisition. Ronnie Andrews, president of medical sciences at Life Tech, said last week that the Navigenics transaction gave it "the immediate ability to be in a CLIA lab in 50 states" and that it planned to use the lab to "drop in proprietary LDTs that we know today can have an impact" on cancer diagnostics and therapy selection (PGx Reporter 7/18/2012).

Pinpoint specifically gives Life Tech a foothold in the lung cancer prognosis space, which poses a significant opportunity for the company's nascent molecular diagnostic effort. Given that there are 1.5 million deaths worldwide due to lung cancer, and drug and diagnostics developers are investing in molecularly characterizing the disease in an effort to personalize treatments and improve outcomes, a prognostic test that can assess disease progression in lung cancer patients could be a top seller in Life Tech's molecular diagnostics pipeline.

"Although we've realized impressive gains against many forms of cancer, the survival rate for lung cancer hasn't changed in 30 years," said Andrews in a statement announcing the Pinpoint acquisition. "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."

Oncologists currently use patients' clinical factors, such as tumor size, location, and whether the tumor has spread to the lymph nodes, in order to diagnose lung cancer. After patients' tumors are removed with surgery, doctors monitor patients to try to gauge whether their disease is worsening and if they need to be treated with 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, 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."

Although the National Comprehensive Cancer Network recommends Stage IB and Stage II patients be treated with adjuvant chemotherapy, the use of clinical factors alone makes it difficult for doctors to discern which patients are at low risk of disease progression after surgery and which are at high risk of recurrence and need chemotherapy.

"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," David Jablons, chief of general thoracic surgery at UCSF and a co-founder of Pinpoint, said in a statement.

Pinpoint's lung cancer prognostic test was developed based on technology licensed from UCSF. Life Tech suggested that a molecular diagnostic that can provide more reliable guidance as to which patients can avoid chemotherapy could potentially save healthcare dollars.

After publishing the retrospective studies in The Lancet, the developers of the test are planning a prospective study in which patients with stage I non-squamous NSCLC will be tested with the Pinpoint's assay. Those patients identified at high risk of death will be randomized to either an observation arm or receive adjuvant chemotherapy.

In The Lancet paper, a team led by UCSF researchers reported that the molecular risk categories from the Pinpoint assay outperformed standard clinical risk factors in assessing mortality in lung cancer patients after surgery. "The assay improved prognostic accuracy beyond NCCN criteria for stage I high-risk tumors, and differentiated low-risk, intermediate-risk, and high-risk patients within all disease stages," the study authors wrote. A prospective study will provide more robust evidence of whether adjuvant chemotherapy improves survival in high-risk Stage I patients.

"We see an opportunity in lung cancer to change the treatment paradigm with more effective diagnostics," Life Tech CEO Gregory Lucier said in a statement. As the company "moves further into the diagnostics space, we will focus on tests that have strong clinical utility where there is a large unmet need."

Life Tech has not disclosed the financial details of the Pinpoint or Navigenics acquisitions, but said it expects them to be dilutive to its earnings for the next two years and then accretive in subsequent years. These acquisitions follow a number of diagnostic collaborations that Life Tech has recently inked with pharma and hospitals.

In October last year, Life Tech partnered with GlaxoSmithKline to develop a companion test for the drug developer's MAGE-A3 cancer immunotherapy. As reported by PGx Reporter sister publication Clinical Sequencing News, Life Tech is also helping Gen-Probe garner regulatory clearance for a transplant diagnostic and other assays operating on its 3500 Dx Genetic Analyzer capillary electrophoresis sequencer.

Separately, Life Tech is collaborating with Boston Children's Hospital and the Hospital for Sick Children in Toronto to develop next-generation sequencing-based workflows for pediatric disease research.

Life Tech did not respond to questions for this article ahead of press time.

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