CLN Article

Industry Profiles

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Genisphere Licenses Signal Amplification Technology to Chembio

Chembio Diagnostics, Inc. has signed an agreement for Genisphere's 3DNA Signal Amplification technology that could help the company broaden the potential applications of its Dual Path Platform (DPP) rapid diagnostic pipeline tests by improving their detection limits. According to the company, the 3DNA Dendrimer technology increases an assay's sensitivity 100-fold without making the assay more complex. To date, this technology has been used to enhance the performance of many test platforms for protein and nucleic acid detection, including microarrays, ELISAs, bead-based flow cytometry, and lateral flow assays.

Prior to this agreement, the two companies conducted a feasibility study together to show that 3DNA Dendrimer technology can be adapted to Chembio's DPP. "Sensitivity, specificity, and reproducibility are important features for all diagnostic tests," said Lawrence Siebert, Chembio's chief executive officer.

Life Technologies, Merck Serono Form Co-Diagnostics Partnership

Life Technologies and Merck Serono have inked a non-exclusive agreement to collaborate on current and future companion diagnostics projects. This marks the first time the two companies have worked together. Initially, they will focus on an oncology project, then will branch out across a potentially wide range of therapeutic areas and Life instrument systems. Among the targets are co-diagnostics for Merck drugs.

"The Life Technologies combination of platforms and capabilities are unique in the companion diagnostics space, particularly in oncology," said Ronnie Andrews, president of Genetic and Medical Sciences at Life. "With our recent acquisition of Compendia Bioscience, we possess bio-informatics solutions and cancer biomarker expertise to collaborate with pharma on each phase of the drug development process, from biomarker hypothesis to assay development concurrently with drugs to approved diagnostic tests."

If this collaboration between Life and Merck succeeds, the two companies will follow it with an additional agreement that allows Life to commercialize the co-diagnostics.

Cell Signaling Technology, Cepheid Collaborate on Lung Cancer Test

Cell Signaling Technology, Inc. (CST) has licensed patent rights to Cepheid, Inc. that will allow Cepheid to develop a PCR-based diagnostic test to identify non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) gene rearrangements. CST and one of its partners own dominant intellectual property rights for EML4-ALK translocations in NSCLC that cover research through diagnosis and therapy. These patent rights include method claims for the detection of EML4-ALK through immunohistochemistry, PCR, gene sequencing platforms, and molecular-based methods, as well as inhibiting the progression of lung cancers that express the EML4-ALK fusion gene.

PAML Forms Collaboration With Cleveland Clinic Laboratories

PAML signed a letter of intent with Cleveland Clinic Laboratories to explore ways to collaborate in the areas of test development, value-based care, analytical tools, and companion diagnostics for better therapeutic decision making. "In the age of healthcare reform, we have a responsibility to improve the delivery of laboratory diagnostic services and increase clinical efficiency and outcomes," said Francisco Velazquez, MD, president and chief executive officer of PAML. Based in Spokane, Wash., PAML specializes in reference lab testing and information technology, while Cleveland Clinic Laboratories offers state-of-the-art testing to clients nationwide.

Bio-Reference to Maintain Free Genetic Laboratory Service

Bio-Reference Laboratories, Inc. and the University of Washington, Seattle, forged a deal to make,, and all related properties a business unit of Bio-Reference. Founded in 1992, provides physicians, geneticists, and genetic counselors with comprehensive information about testing for inherited disorders and genetic counseling services. The public, as well as participating labs and clinics, can access the site's directories of international labs and clinics offering genetic testing and counseling free of charge.

Under the new licensing agreement, has improved its search function and plans to enhance data-entry capabilities, as well as add new services and information, particularly on multi-gene panels. The website will continue to link to GeneReviews, a collection of peer-reviewed chapters written by experts describing inherited diseases and the use of genetic testing in diagnosis, management, and genetic counseling.

"As the field of genetics has grown more complex and specialized, has become one of the most indispensable tools of the trade as a single source of information on genetic test availability," said founder Roberta Pagon, MD. "Initially, the lab directory was used primarily by geneticists, but today clinicians in all specialties, such as cardiology, endocrinology, and neurology, rely on