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Quest Diagnostics, Epigenomics, Siemens Healthcare, FDA, Perlegen Sciences, SC Liver Research Consortium, Roche, Ventana, Celera, Geisinger Health System, AstraZeneca, GVK Biosciences, Siemens, National Jewish Medical and Research Center

Quest Licenses Epigenomics’ Methylation Marker to Develop Blood-Based CRC Test
Quest Diagnostics has signed a non-exclusive licensing agreement for Epigenomics’ Septin 9 DNA methylation biomarker with the goal of commercializing a laboratory-developed blood test for colorectal cancer, Epigenomics said this week.
Epigenomics said that it has demonstrated in “multiple clinical case control studies” with about 3,000 blood samples that methylated DNA of the Septin 9 gene in blood plasma indicates the presence of early-stage colorectal cancer.
Quest plans to develop a Septin 9-based test as a supplement to conventional methods of colorectal cancer screening, including colonoscopy and fecal occult blood tests.
Joyce Schwartz, vice president and chief laboratory officer at Quest, said in a statement that patient compliance with colorectal cancer screening guidelines in the US is currently “dismal.” Often, she said, “patients fail to undergo a colonoscopy or conduct other types of colorectal cancer screenings because they find these methods invasive, unpleasant, or costly.”
She added that a blood test for detecting colorectal cancer would be “a convenient option that complements other screening methods."
Epigenomics said that because Quest is the first US commercial lab to license the Septin 9 marker, the company has granted it exclusivity in the US market for an undisclosed period. In return, Epigenomics will receive upfront and milestone payments as well as royalties on sales of the Septin 9-based tests.
Additional terms of the agreement were not disclosed.
Quest already offers DNA methylation diagnostics for Prader-Willi syndrome and Angelman syndrome.
Epigenomics signed a licensing agreement for the Septin 9 marker with Abbott Molecular in September 2007 covering the development of an in vitro diagnostic blood test for early detection of colorectal cancer.
Abbott and Epigenomics plan to launch a CE-marked Septin 9 IVD in Europe in 2009, and plan to file for approval with the US Food and Drug Administration in 2010.

FDA Gives Nod for Siemens HCV Monitoring Test
The US Food and Drug Administration has approved a hepatitis C viral load assay made by Siemens Healthcare that can help physicians to monitor the disease, the company said this week.
Siemens said its Versant 440 Molecular System was approved for marketing and for use with the company’s Versant HCV RNA 3.0 assay for management of HCV-infected patients.
The Versant 440 viral load measurement system integrates bar code data entry, automated reagent processing, signal amplification detection, and a lab information system interface.
The system received its CE Mark in September 2006, and has been launched in Europe, Africa and in parts of Asia and in the Americas, the company said.

Perlegen, SC Liver Research Consortium to Study Genetics Behind HCV Treatment Response
Perlegen Sciences said this week that it has begun a research collaboration with the SC Liver Research Consortium, a group of physicians and researchers from 50 research sites, with the goal of determining the genetic variations predicting response to hepatitis C treatment.
At the moment, the standard of care for hepatitis C involves treatment with interferon alpha and ribavirin, which cures about half of HCV patients. Nevertheless, these treatments are linked to serious side effects such as fatigue, depression, fever, and anemia, which dissuades many HCV patients from undergoing therapy.
On the other hand, hepatitis C itself can lead to other serious complications such as liver cirrhosis or scarring and hepatocellular carcinoma, a type of liver cancer accounting for 80 percent to 90 percent of all liver cancer cases.
Perlegen and the SCLC researchers hope that by being able to more accurately identify patients who will respond well to interferon alpha and ribavirin treatment, they will also persuade these individuals to undergo the treatment, improving their outcomes.
“This is an exciting opportunity to combine the expertise of our consortium’s fifty research sites with Perlegen’s skills in genetic analysis,” SCLRC President Paul Pockros said in a statement. “The ability to help predict response to therapy could be a vital tool in our effort to cure hepatitis C in millions of patients infected with this virus.”

Roche to Complete Purchase of Ventana
Roche said this week that it has completed the tender offer for Ventana’s outstanding shares and that it expected to wrap up the acquisition of the firm on Feb. 19, “without a vote or meeting of Ventana’s shareholders.”
Roche said that its wholly owned subsidiary Rocket Acquisition Corporation has purchased 34,545,323 shares of Ventana common stock, representing approximately 93.7 percent of the company’s outstanding shares. The total value of the purchase is around $3.4 billion.
Following the merger, all Ventana shares not owned by Roche and its subsidiaries will be converted into the right to receive the same cash consideration that was paid in the tender offer.
"Ventana broadens Roche's diagnostic offerings and complements Roche's strong existing position in in vitro diagnostic systems,” said Franz Humer, chairman and CEO of Roche, in a statement. “Incorporating Ventana will enhance our position as the world's leading, personalized healthcare company."

Celera and Geisinger Collaborate on Liver Diagnostic Test
Celera said this week that it has begun a multi-year research collaboration with the Pennsylvania-based health services company Geisinger Health System to develop an assay for diagnosing a liver condition called non-alcoholic steatohepatitis or NASH.
Around two to five percent of Americans have non-alcoholic fatty liver disease — excess fat accumulation in the liver linked to conditions such as diabetes, obesity, and cardiovascular disease — and about a quarter of these patients eventually develop NASH, serious liver inflammation and scarring that can lead to cirrhosis, Celera said.
Because there are no obvious symptoms for fat accumulation in the liver, most people do not know they have NAFLD until liver damage occurs. NASH, the advanced stage of the condition, is currently diagnosed using ultrasound and needle liver biopsies.
Through their collaboration, Geisinger and Celera plan to develop a diagnostic test for NASH by combining their work on liver genetics, such as Celera’s Cirrhosis Risk Score data, and their available samples, including Geisinger’s bank of more than 600 liver tissue and blood samples.
Financial terms of the collaboration were not disclosed.
“Understanding the natural history of NAFLD and NASH, especially identification of those patients with or at risk for NASH, represents a critical unmet diagnostic need in liver disease,” Mount Sinai’s chief of liver diseases Scott Friedman, said in a statement. “Associations of disease with various gene variants are beginning to provide keen insight into disease mechanisms that may be shared by multiple diseases.”

AstraZeneca Licenses GVK Toxicity Database
Drug giant AstraZeneca has licensed GVK Biosciences’ Mechanism Based Toxicity Database, the Hyderabad, India-based firm announced this week.

The database contains more than 13,000 drug and drug-like compounds, their routes of metabolism, toxic indications, and the numerical values of the measures of toxicity, according to GVK.

The license extends AstraZeneca’s existing license for all of GVK’s target and drug databases. Financial terms of the agreement were not disclosed.


Siemens, National Jewish to Collaborate on Personalized Medicine Research
Siemens and National Jewish Medical and Research Center in Denver will collaborate on developing medical imaging and diagnostic technologies that use genomics, proteomics, and integrated research and clinical care, the partners announced last week.
Although the firms did not disclose what kinds of genomics and proteomics technologies they would employ, National Jewish intends to integrate Siemens’ technologies throughout its institution to help diagnose respiratory, cardiac, and rheumatologic diseases. The center’s Institute for Advanced Biomedical Imaging, which is scheduled to open this spring, will house computer tomography and positron emission tomography-CT systems, as well as other imaging systems, made by Siemens.
The Institute will carry out the collaborative research between the partners, they said.
“Integrating new concepts for early detection, including state-of-the-art imaging and information technologies, as well as molecular methods, will help support our shared vision of personalized healthcare,” Heinrich Kolem, CEO of Siemens Medical Solutions USA, said in a statement.
In 2005, Siemens acquired Bayer Diagnostics for approximately $5.25 billion and Diagnostic Products for nearly $2 billion in a bid to dramatically expand its in vitro diagnostics offerings and provide a complementary portfolio of technologies for its in vivo imaging systems. The firm has said that the combination of Bayer’s molecular diagnostics products with its own molecular imaging technologies is part of its broad “patient-centric” product development strategy.
Siemens’ rivals in the medical imaging field, including GE Healthcare and Philips, have also become more involved in molecular medicine research through a variety of collaborations.

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