August 2010 Clinical Laboratory News: Industry Profiles

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August 2010: Volume 36, Number 8 

Roche, IBM to Develop Nanopore-based DNA Sequencing Technology

Roche Holding and IBM will team to develop a nanopore-based technology that will directly read and sequence human DNA. Developed by IBM, DNA Transistor technology provides true single molecule sequencing by decoding molecules of DNA while they are threaded through nanometer-sized pores in a silicon clip. Under the agreement, Roche will finance continued development of the technology at IBM. According to both companies, the technology could enhance throughput and cut costs to the point that the whole human genome could be sequenced at a price between $100–1,000.


Critical Path’s Drug Toxicity Tests Accepted by Japanese Agency

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has accepted new biomarker tests to detect drug-induced kidney injury. PMDA's announcement marks the first-ever regulatory biomarker qualification decision for Critical Path Institute (C-Path), under its new special consultation process on pharmacogenomics/biomarkers. C-Path’s Predictive Safety Testing Consortium (PSTC) submitted the data for seven urinary protein biomarkers—KIM-1, albumin, total protein, β-2 microglobulin, cystatin C, clusterin, and trefoil factor-3—and indicated that the first six perform better than the current standard biomarkers, serum creatinine and blood urea-nitrogen. The Japanese agency will now consider data on a case-by-case basis for these markers from clinical trials to further qualify their usefulness in monitoring drug-induced renal toxicity.

Patent for Alzheimer’s Disease Biomarker Granted to Vermillion

Vermillion, a molecular diagnostics company, announced that the Patent and Trademark Office granted a patent for the company’s “Biomarkers for Alzheimer’s Disease.” “The granting of our Alzheimer’s disease biomarker patent is additional validation of our approach to intellectual property protection. We view the increasing breadth of our patent portfolio as a significant corporate asset,” said Gail S. Page, chief executive officer and chairperson of Vermillion. The patent claims are aimed at biomarker combinations for the diagnosis and management of Alzheimer’s disease.

Mayo Clinic, University of Illinois Join Forces on Healthcare Technology

Mayo Clinic and the University of Illinois have announced a new partnership for research into technology-based healthcare aimed at point-of-care diagnostics, individualized medicine, and telemedicine. The partnership will combine current technologies at both institutions, specifically Mayo’s extensive clinical expertise and biomedical research and the University of Illinois’ knowledge in computational science, imaging, data security, and bioengineering.

“The alliance is very synergistic,” said Jennifer Eardley, associate vice chancellor for research at the University of Illinois. "There's not a lot of overlap, each of us brings our own capabilities to the partnership.” This research alliance is expected to benefit clinicians in diagnosis and care of patients, especially as more physicians in the U.S. adopt health IT such as electronic health records.

Affymetrix and Signature Dx Collaborate on Cancer Test

Affymetrix and Signature Diagnostics have signed an agreement giving Signature a worldwide license to use Affymetrix’s microarray technology to develop and commercialize diagnostic and prognostic colorectal cancer (CRC) tests. According to Signature, their plan is to introduce two microarray-based IVD tests for colorectal cancer in late 2010. “Our novel Detector C blood screening product together with Affymetrix’s gene expression array technology bring CRC screening to a new level of accuracy and sensitivity,” said Andre Rosenthal, Signature Diagnostics’ chief executive officer. Signature first will launch the test in Europe and then plans to seek U.S. regulatory approval in the future.

Claros Diagnostics’ POC PSA Immunoassay System Cleared by EU

European regulators have granted Claros Diagnostics clearance for its quantitative, point-of-care prostate specific antigen immunoassay to be sold throughout the European Union. According to the company, this move will facilitate the commercial rollout of the system in all major world markets. The lab-on-a-chip-based test, which takes around 15 minutes to run, includes a transportable analyzer and credit card-sized disposable cartridge. This clearance also marks the first step in Claros’ plan to produce an array of products for the point-of-care market.

Gen-Probe Invests in PacBio to Fund Sequencing-based Diagnostics

Pacific Biosciences has received a $50 million investment from Gen-Probe, a molecular diagnostics firm, to co-develop sequencing-based diagnostics. The test will be based on PacBio’s “version 2” technology, which is slated to start in 2014, and could be applicable for point-of-care diagnostics and clinical laboratories. The two companies plan to develop the new system using PacBio’s Single Molecule Real Time (SMRT) platform and Gen-Probe's knowledge in diagnostics. “We see a significant opportunity for our SMRT platform in the molecular diagnostics market and are taking a proactive and strategic approach by collaborating with Gen-Probe, a proven leader in developing fully automated instrument systems for nucleic acid testing,” said PacBio chief executive officer Hugh Martin.

Companies Collaborate on Companion Diagnostics

Aeterna Zentaris Inc. a late-stage drug development company specializing in oncology and endocrine therapy, will launch a collaborative study with Almac’s Diagnostics division for the company's doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108, aimed at determining LHRH receptor expression through the development of a companion diagnostic tool.

“This state of the art companion diagnostic tool will allow us to develop improved methods of selecting the most appropriate patients to be treated with AEZE-108 in order to enhance the efficiency of four clinical trials and help us with the future successful developments of AEZE-108 in a number of different LHRH-expressing cancers,” said Juergen Engel, Aeterna Zentaris president and chief executive officer. The companies’ strategy is to use results of the test to help guide treatment with AEZE-108 according to a personalized medicine model.

Generation Health, PGXL to Provide Pharmacogenetic Testing

Generation Health has teamed with PGXL Laboratories in an effort to be the top genetic testing lab offering molecular diagnostic test services for Generation Health. The pilot program kicks off in August, and the partners will offer pharmacogenetic testing and diagnostic services to a limited number of patients through healthcare providers. The services will be open to all Generation Health patients in January 2011.

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