July 2010 Clinical Laboratory News: Industry Profiles

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July 2010: Volume 36, Number 7



New Captial for Exosome Diagnostics

Exosome Diagnostics announced that NGN Capital and Forbion Capital Partners have invested $20 million to continue developing and commercializing the firm’s exosome-based diagnostics. Founded in 2008, Exosome uses technology licensed from Massachusetts General Hospital to test for cancer-specific genes in blood and urine. Exosomes are lipid-covered microvesicles shed by solid tumors into body fluids, and tumor exosomes contain nucleic acid sequences of a cancer’s genetic make-up.

In announcing the capital infusion, Exosome indicated that it has been able to extract exosomes from blood and urine samples of cancer patients and detect key genes and gene mutations associated with a variety of cancers with high sensitivity and specificity.

Asuragen Licenses BRAF Mutation from Johns Hopkins

Asuragen announced that it has acquired a non-exclusive license from Johns Hopkins University to incorporate the BRAF V600E mutation sequence into its molecular diagnostic products and for use in Asuragen’s CLIA-certified lab for clinical research and patient testing. Financial terms were not disclosed.

The V600E mutation in the BRAF oncogene results in a constitutively active BRAF protein and has been shown to impact prognosis and prediction of therapeutic response in colorectal cancer and thyroid cancer. The mutation can be detected by DNA testing of tumor biopsies and resected tumor tissues. BRAF is a component of the EGFR/MAPK signaling pathway, which is the target of several approved drugs as well as drugs currently in clinical and pre-clinical development.

Asuragen has included the BRAF mutation in its Luminex-based Signature KRAS Mutations assay to expand coverage of the EGFR/MAPK signaling pathway. The company also plans to offer BRAF mutation testing in its services laboratory for clinical trials and companion diagnostics studies.

“This agreement…will enable Asuragen to expand its mutation testing for a range of cancers,” said Asuragen president Rollie Carlson. “The integration of BRAF into our existing multiplex tests on the Luminex platform allows us to provide rapid and streamlined tests for a number of clinical and research applications.”

CVS Caremark, Generation Health Announce PGx Alliance, Covered Drugs

CVS Caremark and Generation Health announced that they will offer an integrated genetic benefit management service, with testing coordinated through the collaborative’s Best Test Genetics Network, a preferred provider organization of diagnostic service providers that offer evidence-based genetic and molecular testing. The companies also identified the first 13 drugs that will be part of the service.

“We developed this program by reviewing the scientific and clinical evidence to determine where we can have the greatest impact to improve pharmacy care for clients by making genetic benefit management an integral part of our pharmacy benefit management offering,” said Troyen Brennan, MD, MPH, executive vice president and chief medical officer of CVS Caremark. “There is a growing desire by clients to tailor pharmaceutical treatment based on genetic inheritance and our new program helps save payers and patients time and money while improving health outcomes.”

Of the drugs involved in the service, six generally are dispensed through pharmacy benefit management, including Imuran, Nolvadex, Plavix, Tabloid, Tegretol and Ziagen, and seven dispensed through CVS Caremark’s specialty pharmacy business, including Pegasys, Copegus, Gleevec, Tasigna, Sprycel, Tarceva, and Tykerb.

“This offering strengthens CVS Caremark’s efforts to provide clients with a sophisticated, evidence-based approach to genomic medicine,” noted Rick Schatzberg, CEO of Generation Health. “The emerging field of genomics is complex and challenging and this offering will allow employers to better manage the process for ensuring that their employees are receiving the most effective genetic testing and access to genetic experts, resulting in prescribing tailored to individuals.”

The integrated genetic benefit management service offering initially is being implemented for a select group of CVS Caremark’s clients but will be available to all customers in January 2011.

GE Healthcare Partners with CardioDx on Molecular Diagnostics

GE Healthcare has taken a $5 million stake in molecular diagnostics firm CardioDx as part of a Series D funding round for the Palo Alto, Calif.-based startup. The investment came from GE’s Healthymagination Fund, a $250 million pool established to invest in companies developing technologies that have the potential to reduce costs, increase access, and improve the quality of healthcare.

The two firms also have formed an alliance to co-develop diagnostic technologies for the care and management of patients with cardiovascular disease. CardioDx is working on a gene expression-based test—Corus CAD—that is expected to indicate the likelihood that a patient has obstructive coronary artery disease. Such a test would enable clinicians to determine a patient’s status non-invasively, rather than through both invasive and non-invasive methods.

“The alliance with CardioDx gives us access to new and exciting technologies in high-value diagnostics, which will complement and strengthen our existing offerings,” said Pascale Witz, president and CEO of GE Healthcare’s Medical Diagnostics business. “CardioDx is an excellent strategic fit with GE Healthcare, given our common focus on cardiovascular disease.”

InDevR to Develop Influenza Assay with CDC

InDevR announced that it will collaborate with the Centers for Disease Control and Prevention (CDC) to develop a low-density microarray that will be able to screen influenza viruses for genetic reassortment. The array, which will be coupled with InDevR’s ampliPHOX system, will facilitate point-of-service screening to track the emergence of viruses like H1N1 in which genetic mixing occurred between viruses that had adapted to different species. The microarray technology “could greatly enhance global influenza surveillance efforts, which will provide essential time-critical information for vaccine preparation,” according to Kathy Rowlen, InDevR’s co-founder and CEO.

CDC is funding the initiative through a 2-year internal grant; InDevR will function as a subcontractor while working alongside CDC scientists. The joint effort “will leverage our combined experience with low-density microarray development, CDC’s expertise in influenza surveillance, and InDevR’s new ampliPHOX colorimetric detection technology,” explained Rowlen. Financial terms of the contract were not immediately available.

Qiagen, Roche Settle Dispute Over Companion Dx

Qiagen announced that it has signed an agreement with Roche Molecular Systems resolving a dispute over distribution rights for a set of companion diagnostic products developed and manufactured by Qiagen’s subsidiary, DxS. The companies also dropped claims filed against each other that were pending in federal district court in New York.

Roche had filed suit in February against DxS, alleging that it was trying to terminate a distribution deal signed in 2008 for reasons that Roche believed were invalid. This arrangement had covered DxS's Thera-Screen K-RAS Mutation Test and the Thera-Screen EGFR 29 Mutation Test.

Under the terms of the settlement, Roche maintained rights to distribute the two assays under the DxS TheraScreen label, and, under certain conditions, to distribute future versions of the tests. Qiagen obtained rights to distribute these assays under the Qiagen label and also obtained exclusive distribution rights for all other assays, including future assays, developed and manufactured by DxS. The company also granted Roche the option to extend the distribution term of agreement for the TheraScreen EGFR assay beyond 2011, when the current agreement term ends. Qiagen plans to use the Qiagen TheraScreen label for the assays it distributes.

“We are pleased to have reached this agreement with Roche. The agreement provides a clear distribution plan for Qiagen’s pioneering TheraScreen companion diagnostics,” said Qiagen’s CEO, Peer Schatz. “Companion diagnostics help physicians to customize therapies, greatly reduce healthcare costs and prevent harmful treatments for patients suffering from serious diseases.”

Affomix, University of Montreal Sign Agreement

Affomix announced that it has signed a collaboration agreement with the University of Montreal Pharmacogenomics Centre and the Montreal Heart Institute to develop reagents that will enable the quantitative multiplexed profiling of proteins the Centre believes will be useful in predicting and evaluating response to novel anti-atherosclerotic agents in patients with cardiovascular disease. The Centre is particularly interested in using diverse genomic and proteomic platforms to discover novel biomarkers that are predictive of drug efficacy and toxicity.

“Having the ability to consistently measure these cardiovascular proteins represents a key first step in identifying important biomarkers that will help us better understand atherosclerosis and how patients respond to certain medications”, said Jean-Claude Tardif, MD, director of the Montreal Heart Institute. “We are pleased to be working with Affomix because they have the ability to produce a large number of high quality antibodies in a format suitable for quantitative, multiplexed protein analysis. This will allow us to produce superior assays that could identify biomarkers that could further the field of personalized medicine.”

Affomix uses high throughput methodologies to select rapidly against native epitopes and post translationally modified proteins. The company’s ultimate objective is to generate a comprehensive set of antibodies that can be used to detect and quantify all proteins in the human proteome.

“Our commercialization plan at Affomix has been to align the Company’s unique antibody-based capabilities with existing high throughput, multi-analysis platforms, including next generation DNA sequencers, thus providing quantitative proteome data to complement state-of-the-art genomic analyses,” explained John Boyce, head of business development at Affomix. “We believe that the combination of our technological skills with the considerable clinical and informatics expertise of the Montreal Heart Institute could truly unlock the promise of pharmacogenomics.”

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