December 2009 Clinical Laboratory News: Industry Profiles

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December 2009: Volume 35, Number 12

GE Announces $250 Million to Support Health IT, Diagnostics

General Electric (GE) announced the formation of the GE Healthymagination Fund, a new equity fund that will invest in promising healthcare technology companies. The fund will primarily focus on innovative companies pioneering research in diagnostic, IT, and life science technologies, as well as healthcare companies developing unique business models and services. Diagnostic technologies specifically highlighted for investment include home health, patient monitoring, molecular diagnostics, pathology, and novel imaging agents. The fund is part of GE’s $6 billion Healthymagination initiative.

BD Acquires HandyLab

Becton Dickinson (BD) signed a definitive agreement to acquire HandyLab, a manufacturer of diagnostic assays and automation platforms. Building upon a previously announced development and distribution agreement between BD and HandyLab from 2009, the acquisition will support BD’s molecular diagnostics strategy. “HandyLab has developed and commercialized a flexible automated platform for performing molecular diagnostics that is an ideal complement to our molecular diagnostics offerings,” said Vincent A. Forlenza, BD president. BD plans to place its BD GeneOhm molecular assays for Methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, and Vancomycin-resistant Enterococcus (VRE) onto the HandyLab platform and market them as the BD MAX system. The acquisition is expected to close in the first quarter of 2010. Financial terms of the agreement were not disclosed.

Myriad Acquires Rights to Pancreatic Cancer Gene Patents

Myriad Genetics acquired the exclusive license to patents covering mutations in the PALB2 gene from Johns Hopkins University (JHU). The mutations have been linked to increases in an individual’s risk for developing pancreatic cancer. The PALB2 gene is a tumor suppressor gene that serves as a binding partner with BRCA2, allowing both genes to work together to repair DNA damage. Scientists at the Sol Goldman Pancreatic Cancer Research center at JHU identified the traits of the PALB2 gene and published their findings earlier this year. Combined with Myriad’s already extensive catalog of additional genes for pancreatic cancer, Myriad hopes to develop a novel molecular diagnostic test to assess the risk for hereditary pancreatic cancer by 2010. “At the present time, pancreatic cancer is difficult to diagnose early, resulting in few options to help improve patient survival,” said Gregory C. Critchfield, MD, president of Myriad Genetic Laboratories. “Knowing who is at higher risk of pancreatic cancer will allow for the development of strategies for early detection and possible prevention of this deadly disease, giving doctors and patients tools to better address this cancer.

Exact Sciences Licenses Invader Technology from Hologic

Exact Science obtained a worldwide license from Hologic for the company’s Invader, Invader plus, and real-time Invader detection technologies used for colorectal cancer screening. The Invader chemistry series is a molecular detection platform that Exact Science plans to combine with digital PCR technology exclusively licensed from Johns Hopkins University. The license agreement gives Exact Science an edge in the stool-based DNA (sDNA) screening market. The company’s intellectual property portfolio now includes detection technologies, sDNA testing methods, and important biomarkers that can be used to develop colorectal screening tests. Financial terms of the license agreement were not disclosed.

ZyGEM, Phthisis Join to Produce Pathogen Detection Devices

ZyGEM and Phthisis Diagnostics announced that they have entered into an agreement to develop devices for the detection of infectious pathogens in complex samples, such as stool, blood, and water. The collaboration will bring together ZyGEM’s nucleic acid extraction technology and Phthisis Diagnostics’ molecular diagnostic expertise in obtaining DNA samples from infectious pathogens. The companies’ first task will be extracting pathogen DNA from stool. “We are committed to developing innovative technologies that provide researchers and clinicians with products to accurately, simply, and cost-effectively perform molecular detection assays, and we believe that access to ZyGEM’s distinctive temperature-controlled nucleic acid extraction technology will help advance that goal,” said Crystal R. Icenhour, PhD, president and director of research of Phthisis Diagnostics. Additional terms of the agreement were not disclosed.

Qiagen to Purchase SABiosciences for $90 Million

Qiagen announced that it has signed a definitive agreement to acquire SABiosciences, a manufacturer of PCR assay panels. SABiosciences’ product line includes more than 100 real-time PCR assay panels for high performance analysis of DNA, RNA, and microRNA targets associated with cancer, diabetes, and immune and cardiovascular diseases, as well as pathways for apoptosis, signal transduction, and toxicology. “The addition of SABiosciences will boost our biological content engine significantly by adding to our position as a premium partner for the pharmaceutical industry and to the use of this position to yield diagnostic content for prevention, profiling, and, most significantly, personalized healthcare,” said Peter Schatz, CEO of Qiagen. The deal is valued at $90 million and expected to close at the end of December, following approval by SABiosciences’ stockholders.

Satoris Awarded Foundation Grant to Develop Parkinson’s Disease Markers

Satoris announced that it has received a grant from the Michael J. Fox Foundation to study plasma protein panels from patients with Parkinson’s disease. The study, which is being performed in collaboration with Bernard Ravina, MD, associate professor of neurology at the University of Rochester School of Medicine, will compare the relative amounts of 500 plasma proteins from 25 Parkinson’s disease patients with those from 25 healthy individuals. “We will use proprietary antibody arrays to measure over 500 distinct plasma proteins and attempt to identify a cellular signal for the disease,” said Cris McReynolds, president and CEO of Satoris. “If we’re successful, the next step will be further studies using larger number of samples. Ultimately, we hope to develop and commercialize a diagnostic blood test.”

Epigenomics, Quest Complete Development of Colorectal Cancer Test

Epigenomics announced that Quest Diagnostics completed clinical validation of its Septin9 laboratory-developed blood test for the detection of colorectal cancer. “Validation of our Septin9 laboratory-developed test is an important step forward in providing a test that physicians can use to help them identify patients with colorectal cancer,” said Jay G. Wohlgemuth, MD, vice president of Science and Innovation at Quest Diagnostics. “We intend to release the test in the U.S. later this year.” Under terms of the licensing agreement Epigenomics will receive a milestone payment from Quest for the completion of this validation, however the amount of the payment was not disclosed.

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