Industry Playbook

OncoCyte, Weill Cornell Aim to Develop More Accurate Lung Cancer Test
The United States Preventative Services Task Force (USPSTF) recently recommended that healthcare providers annually screen patients at high-risk for lung cancer using low-dose computed tomography (CT). However, CT has a false-positive rate of approximately 25% when used to detect lung cancer. OncoCyte Corporation, in collaboration with Weill Cornell Medical College in New York City, hopes to develop a multi-marker test for lung cancer that could serve as a more accurate alternative to CT.

Under the terms of a license agreement between OncoCyte and Cornell University, Weill Cornell Medical College will provide blood samples from healthy individuals and lung cancer patients for comparative analysis using OncoCyte's PanC-Dx diagnostic tests. The PanC-Dx tests are noninvasive cancer diagnostics based on a proprietary set of biomarkers that are characterized, in part, by broad expression patterns in numerous cancer types. OncoCyte scientists plan to determine levels of tumor-associated gene expression—including levels of the PanC-Dx markers—in the samples from Weill Cornell. The results of these analyses, along with the results of a nearly completed clinical study being conducted by OncoCyte's collaborators at The Wistar Institute, will then be combined to produce a data set from more than 700 markers for the development of the multi-marker lung cancer test. OncoCyte believes such a test could help healthcare providers to fulfill USPSTF's screening recommendations.

"Large scale screening of [high-risk patients] could reduce overall lung cancer mortality through earlier detection," said Joseph Wagner, PhD, OncoCyte's CEO. "However, the high number of false-positive tests could lead to over a billion dollars a year in unnecessary costs to the United States healthcare system as a result of associated follow-up testing. Physicians, payers, and patients would therefore welcome a simple to use, low-cost, blood-based test that can help guide patient-management decisions by noninvasively ruling out the presence of cancer."

Roche and Ferring Collaborate on Infertility Co-Diagnostic
Roche and Ferring Pharmaceuticals have entered a partnership to enable healthcare professionals to personalize infertility treatment to a woman's specific needs. Under the terms of this agreement, Roche will work with Ferring to validate and seek regulatory approval for a companion diagnostic test—the Elecsys AMH—to be used in combination with Ferring's human recombinant follicle-stimulating hormone (rFSH), a gonadotropin that is currently in development. The Elecsys AMH is a fully-automated­ assay that aims to assess anti-Mullerian­ hormone (AMH) levels, which are a measure of a woman's ovarian reserve and ovarian response to infertility treatment with gonadotropin. With this information, doctors will be better able to deliver a personalized dose of Ferring's human rFSH based on a woman's AMH level. If successful, this personalized dosing may improve the predictability of infertility treatment, and as a result, lower the potential burden of treatment for women seeking to conceive through assisted reproductive technology.

OMI to Develop Chronic Fatigue Syndrome Biomarkers With Support From Affymetrix

The Open Medicine Institute (OMI), an organization that strives to improve healthcare by harnessing the potential of big data, plans to develop biomarkers for chronic fatigue syndrome (CFS) and other prevalent chronic but difficult-to-diagnose diseases. Initially, the organization intends to use RNA expression data from patients and healthy volunteers to develop a biomarker test for the detection of CFS, as well as a second test to evaluate treatment efficacy. This project will be led by OMI and will also use Affymetrix's microarray technology and platform.

"With applications and expertise support from Affymetrix, we are looking forward to developing biomarkers for this enigmatic disease that affects more than 8 million people globally," said Andreas Kogelnik, MD, PhD, founder of the Open Medicine Institute. "There is so much misinformation about CFS, we need to focus new tools and technologies on this disease to fully understand and treat it."

Currently, there are no proven diagnostics or treatments for CFS, forcing many patients and physicians to rely on anecdotal efficacy claims about multiple therapies as they search for one that works. As a result, fewer than 20% of individuals with CFS are diagnosed and treated correctly.

Abbott, Biocartis Partner on Multiplex Companion Diagnostics

Abbott and Biocartis have teamed up to develop and commercialize companion diagnostic tests. Under the terms of their agreement, the companies will leverage Biocartis' molecular diagnostics system, Idylla, as well as Abbott's regulatory, scientific, and commercialization experience. The partnership plans to collaborate with pharmaceutical companies to create various biomarker panels for use on the Idylla system, where each marker in the panel will have a known clinical significance. Idylla is designed to enable multiplexing, which is important for pharmaceutical companies that need to analyze multiple biomarkers in their clinical trials. Ultimately, this capability will also help physicians to obtain more useful information from limited patient samples.

Bio-Rad to Provide Quality Controls to Members of Premier
Bio-Rad Laboratories has expanded its contract with Premier, one of the largest group purchasing organizations based in the U.S. The agreement extends Bio-Rad's comprehensive quality control and data management contract, along with other immunohematology products, to Premier members, including Premier general level and ASCEND members. Overall, these members consist of 2,900 community hospitals and 100,000 alternate sites across the U.S. Premier and Bio-Rad initially signed this deal in 2002.

Qiagen and Eli Lilly Embark on Fourth Cancer Co-Diagnostic Project

Qiagen and Eli Lilly are collaborating to develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers associated with multiple cellular pathways involved in common cancer types and targeted by cancer therapies under development by Lilly. Their agreement includes the development of tests that will be based on Qiagen's multi-modal, multi-analyte Modaplex analysis platform, which can process multiple sample types and biomarkers in a single test. This is the fourth project that Qiagen and Lilly have undertaken during their long-standing partnership.

Ventana Partners With MedImmune on Co-Diagnostic for Lung Cancer Clinical Trials
Ventana, a member of the Roche Group, and MedImmune, the global biologics research and development arm of AstraZeneca, have joined forces to develop an investigational use only programmed cell death-ligand 1 (PD-L1) immunohistochemistry assay. This test will be used to enroll patients in clinical trials for MedImmune's MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma, including the recently commenced MEDI4736 ATLANTIC trial that will only enroll patients who express PD-L1 as determined by the Ventana assay. MEDI4736 is an engineered human monoclonal antibody directed against PD-L1, a ligand that helps tumors avoid detection by the immune system. Researchers believe that by targeting PD-L1, MEDI4736 may block this ligand from sending out signals to T-cells to ignore tumor cells, countering lung cancer's immune-evading tactics.

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