Skip to main content
Premium Trial:

Request an Annual Quote

MDx/CDx Focus: Another CDx Deal for Dako, Amgen; NYDOH Clears Enzo to Market ColonSentry

Premium

Dako, Amgen Ink CDx Deal for Undisclosed Oncologic

Dako and Amgen announced they will partner to develop a companion diagnostic for an undisclosed oncology drug that Amgen is currently advancing in clinical trials.

This is the second deal between the firms in the last two months.

In January, Dako announced it was working with Amgen to develop a companion test for an investigational treatment for "a rare and deadly cancer." The partners also have not disclosed the drug candidate involved in this earlier deal (PGx Reporter 1/11/2012).

For the latest collaboration, Dako refused to say which cancer the current diagnostic development deal is focused on. However, a company spokesperson said Dako will be responsible for the development and commercialization of a test that will accompany an Amgen drug.

If successful clinical trials lead to a commercialized Rx/Dx personalized medicine product, then "the two parties will also collaborate/align on commercial activities where Amgen will focus on oncologists and Dako will focus on pathologists," the Dako spokesperson told PGx Reporter in an e-mail.

Outside of its collaborations with Amgen, Dako is a leading player in the companion diagnostics market, with deals in place with AstraZeneca, Bristol-Myers Squibb, and Genentech.


Enzo to Begin Offering ColonSentry Dx with NY Health Department Approval

Following approval from the New York State Department of Health for its clinical laboratory, Enzo Biochem said it will begin marketing the ColonSentry test to clients starting in March.

ColonSentry, originally developed by GeneNews, is a blood-based diagnostic that gauges the expression of seven mRNA biomarkers associated with increased risk of colon cancer or disease severity in patients at the time the test is performed.

According to Enzo, physicians can interpret the status of these seven biomarkers to identify patients who have an increased current risk of having colorectal cancer and to decide whether patients need a colonoscopy

In 2010, GeneNews presented data from a 786-patient study in which ColonSentry detected right-sided colorectal cancer across all stages with the same sensitivity with which it detected left-sided lesions. Colnoscopy, the current gold-standard for colorectal cancer detection, has generally been shown to be more effective in detecting tumors on the left side of the colon (PGx Reporter 9/1/2010).

Enzo believes that greater adoption of ColonSentry may motivate more patients to undergo colon cancer screening, which could lead to earlier detection of disease and improve their chances of survival. "The test requires only a small sample of blood and can thus be easily incorporated as a pre-screening measure into routine yearly physical exams," Enzo said.

According to Enzo, it is the only lab that has NYDOH approval to market this test in the state. Under its exclusive licensing deal with GeneNews for ColonSentry, Enzo also plans to market the test in New Jersey. Enzo is already marketing the test in Pennsylvania and GeneNews sells the test in Canada.


Integrated Diagnostics Secures $10M in Funding

Integrated Diagnostics announced this week that it has secured $10 million as part of its third tranche of its Series A financing.

Integrated Diagnostics raised $30 million in September 2009 as part of its Series A funding round. InterWest Partners, Wellcome Trust, and the Grand Duchy of Luxembourg invested in the third tranche, completing the Series A funding round for the company.

The company said in a statement that it will use the funds to complete clinical development of its in vitro proteomic-based diagnostics programs and prepare them for commercialization. Integrated Diagnostics is developing two proteomic tests, one for the early detection of lung cancer and another for early detection of Alzheimer’s disease. Both tests are based on multiple-reaction monitoring mass spec techniques.

The firm will also apply the $10 million in funding toward advancing its protein-catalyzed capture agents, a new class of molecules that it wants to use to develop in vivo molecular imaging and therapeutics. As previously reported by PGx Reporter sister publication ProteoMonitor, researchers from Integrated Diagnostics and the California Institute of Technology won a $500,000 Gates Foundation grant last year to develop a PCC-based point-of-care test for HIV diagnosis (PM 12/23/2011).


Oxford Gene Technology Garners Exclusive License to Colorectal Cancer Biomarkers

Inven2, the technology transfer office at Oslo University Hospital, and the University of Oslo have granted Oxford Gene Technology an exclusive license to develop and commercialize 12 tissue biomarkers associated with colorectal cancer.

"The exclusive license allows OGT to commercialize any resulting test developed using these biomarkers and to sublicense the markers to other parties," OGT said in a statement.

Ragnhild Lothe of the Norwegian Radium Hospital, which is part of the Oslo University Hospital, discovered the colorectal cancer DNA methylation biomarkers. OGT then validated Lothe's findings and found that the markers have 93 percent sensitivity and 90 percent specificity in gauging patients at risk of colorectal cancer.

The researchers are continuing to investigate the efficacy of these markers in blood-based and fecal samples.

"We believe that developing tests that include these genetic markers will permit the earlier identification of patients at risk of this disease and allow for more timely diagnosis and clinical interventions," OGT CEO Mike Evans said in a statement. "The higher specificity of this new panel of markers could provide a more robust screening tool than the tests currently used, while eventually lowering overall costs."

─ TR