In This Issue...

Siemens, Pfizer Collaborate on Companion Diagnostics
Siemens Healthcare Diagnostics and Pfizer have entered a partnership, under the terms of which the Siemens Clinical Laboratory—a high-complexity testing laboratory focused on advancing personalized medicine—will develop companion diagnostic tests for therapeutics across Pfizer's drug development pipeline. This collaboration will leverage Siemens' expertise in providing clinical diagnostic solutions for hospital and reference laboratories, specialty laboratories, and point-of-care settings. Pfizer will initially use Siemens' tests in clinical studies with the aim of eventually commercializing them on a global scale along with Pfizer's products.

Qiagen and Eli Lilly Continue Developing Cancer Co-Diagnostics
Qiagen has inked a third deal with Eli Lilly to develop and commercialize a molecular companion diagnostic for use with a novel Lilly oncology compound. The oncology compound and molecular diagnostic target involved in this project remain undisclosed, though Qiagen has announced that the resulting test will run on the company's Rotor-Gene Q MDx instrument using real-time PCR technology. Qiagen and Lilly are long-standing partners in personalized healthcare, and previously developed the therascreen KRAS RGQ PCR kit for metastatic colorectal cancer, as well as a co-diagnostic that evaluates the Janus kinase 2 gene that plays a role in some blood cancers.

"Qiagen is a preferred partner for leading pharmaceutical companies like Lilly because our validated development processes and regulatory track record provide an accelerated path to commercialization," said Peer Schatz, Qiagen's CEO. "Using standardized, well-validated processes to develop and commercialize companion diagnostics reduces the risks in drug development for pharma companies."

This latest collaboration between the two companies builds on a master agreement for the development of tailored therapies in cancer and other therapeutic areas signed earlier this year.

Metabolon Partners With G3 in Heart Disease Study
Global Genomics Group (G3) and Metabolon have joined forces to discover novel biomarkers and pharmaceutical targets for cardiovascular disease (CVD). As part of this collaboration, Metabolon will use its TrueVision metabolomics offering to measure and interpret the concentrations of relevant biochemicals and metabolites for the Genetic Loci and Burden of Atherosclerotic Lesions (GLOBAL) study. GLOBAL is the largest pan-omic study to characterize novel disease networks and biomarkers for coronary artery disease. The study uses the advanced imaging technology coronary computed tomographic (CT) angiography to examine and classify disease in eligible patients. This precision phenotyping is then combined with pan-omic analysis involving genomics, epigenomics, transcriptomics, proteomics, metabolomics, lipidomics, and lipoprotein proteomics. Metabolomics contributes to this analysis by providing a complete picture of metabolism, including complex lipid metabolism, which is thought to play an important role in the development of CVD.

In total, the study is projected to "analyze 22 trillion data points from the CT phenotyping and the complete pan-omic analysis to decode the complex biology underlying atherosclerotic disease to identify new drug targets and biomarkers," said Szilard Voros, MD, chief executive officer and co-founder of G3. 

In the fall of 2013, G3 also enlisted Illumina's help for this study. The two companies signed an agreement stipulating that Illumina will conduct whole genome sequencing for GLOBAL.

Claritas, Cincinnati Children's Medical Center to Form Pediatric Genomics Network
Cincinnati Children's Medical Center and Claritas Genomics have teamed up to provide genomics-based diagnostics for pediatric patients. Established by Boston Children's Hospital and Life Technologies Corporation, Claritas is a diagnostics laboratory that currently offers more than 100 genetic specialty tests for clinical providers and researchers with a focus on pediatric medicine. Cincinnati Children's will work with Claritas and Boston Children's to build a collaborative network that will allow pediatric hospitals to share data, expertise, best practices, and infrastructure in medical genetics and genomics for the benefit of patients.

"Boston Children's created Claritas to allow large scale access of the expertise in medical genomics, unique in the pediatric community, to reach larger numbers of patients than would be possible at any single institution. We are pleased that our colleagues at Cincinnati Children's are joining us in this venture," said Sandra Fenwick, president and CEO of Boston Children's Hospital. "Given current financial pressures in healthcare, stand-alone pediatric hospitals will need to collaborate to better leverage resources to accelerate innovations to improve patient care."

Genomic Health, Almac Team Up on Test to Predict Chemotherapy Response
Almac Group has exclusively licensed its technology and intellectual property to Genomic Health for the development of a multi-gene test to identify breast cancer patients who will benefit from DNA damage-based chemotherapy drugs. Such a test would help guide treatment of high-risk—and possibly triple negative—breast cancer patients who are eligible for anthracycline-based chemotherapy regimens. Currently, there is no accurate way to determine who will respond best to these drugs, which are commonly used but have harmful side effects that can debilitate patients and reduce long-term quality of life.

Genomic Health believes its work with Almac will provide further insight into the role of DNA repair in the efficacy of these drugs. Under the terms of the agreement, the company will identify a study cohort for validation of Almac's previously identified and published genes. Genomic Health made an up-front payment of $9 million to Almac, and will pay additional milestones and royalties in the future as clinical and commercial endpoints are reached.

MetaStat Licenses Biomarkers for Metastasis in Epithelial Cancers
MetaStat has signed two separate exclusive worldwide patent and technology license agreements with The Massachusetts Institute of Technology (MIT), its David H. Koch Institute for Integrative Cancer Research at MIT, and its Department of Biology, Albert Einstein College of Medicine of Yeshiva University; and Montefiore Medical Center. These deals allow MetaStat to design tests for the diagnosis and prognosis of metastasis in epithelial solid tumor cancers using alternatively spliced mRNA and protein isoform markers.

"MetaStat has licensed a collection of targets which are alternatively spliced when tumor cells undergo epithelial to mesenchymal transition, or EMT, a process contributing to tumor metastasis and therapeutic resistance for breast and other cancers," said Elizabeth Buck, PhD, MetaStat's chief scientific officer of therapeutics. "Alternatively spliced genes that drive tumor progression and resistance offer a unique opportunity for precision medicine in oncology as MetaStat builds the first platform that directly links a targeted therapeutic to its companion diagnostic based on the detection and targeting of alternatively spliced oncogenes."

In addition to helping MetaStat develop an early and reliable predictor of systemic metastasis, the company also believes this technology improves its intellectual property position surrounding the use of the Mena protein isoforms to differentiate between patients at low or high risk of metastasis.

bioMérieux to Incorporate Life Technologies Instruments Into New Automation Solution
BioMérieux plans to use Life Technologies' Applied Biosystems 7500 real-time PCR instruments as a key component of the comprehensive automation solution it is developing for reference or centralized molecular biology laboratories. This selection will ensure compatibility with bioMérieux's existing PCR assays, most of which are validated on Life's 7500 instruments and aid in the diagnosis of infectious diseases. In addition to Life's instruments, bioMérieux's planned automation solution will include the following modules: NucliSens EasyMag, bioMérieux's sample purification platform, EasyStream, a liquid handling system for the assay PCR set-up, and NucliSentral, a middleware to connect all the platforms.

Cerner, Claritas Partner on Personalized Medicine Initiative
Cerner and Claritas Genomics have entered a collaboration to build tools and connectivity aimed at integrating next-generation sequencing (NGS)-based diagnostic testing into healthcare practice. The two companies plan to develop a rapid, scalable laboratory solution for molecular diagnostics that is adapted to the complexity of NGS workflows and the massive amount of data they generate. As part of this project's initial phase, Claritas will implement Cerner's Millennium Helix solution, which incorporates molecular diagnostic data into patients' electronic medical records (EMRs), and will join Cerner's Reference Lab Network. This will enable seamless ordering and results return for other Reference Lab Network partners, while also giving Claritas access to an existing scalable computing infrastructure that integrates ordering of genomic sequencing tests, laboratory processing, results interpretation, return of results to the clinician, and incorporation of results into EMRs.

"One of Claritas's goals is to enable providers at any pediatric center or practice to use genomics in routine medical care. Effective use of genomics in medicine requires integrating genetic information into the context of the patient's unique clinical presentation," said Patrice Milos, PhD, CEO of Claritas. "As a leading provider of both laboratory management systems and EMR systems in the world, Cerner has decades of experience synthesizing complex medical information across organizations to inform patient care and we are extremely pleased to have them as a strategic partner."