French diagnostics firm ExonHit Therapeutics said last week that it has developed a prototype based on the Affymetrix GeneChip Platform for a blood-based test to identify patients suffering from Alzheimer’s disease.
ExonHit said it expects it to have the test certified and ready to market as early as 2009, placing it on a similar timeline as several firms that have committed to developing diagnostics on the Affy platform, including BioMérieux, Roche Diagnostics, Epigenomics, Almac Diagnostics, and others.
ExonHit, which manufactures its line of splice variant research arrays on both the Affymetrix and Agilent platforms, has recently discussed its intention to move ahead with plans to seek a CE Marking and US Food and Drug Administration clearance for the test, which it claims can distinguish patients suffering from Alzheimer’s disease from those suffering from schizophrenia, bipolar disorder, and depression.
Laurent Bracco, the firm’s vice president of research, said in a statement that the company is also assessing the feasibility of using the test to identify patients suffering from mild cognitive impairment who are at risk to develop Alzheimer-type dementia.
Until now, ExonHit has shied from discussing which platform it deems the most suitable for commercializing the multiplex test. According to John Jaskowiak, the company’s vice president of business and marketing, it is still evaluating options for the Alzheimer’s test, though it has a positive view of the Affy platform.
“We just completed the prototype of this blood-based Alzheimer's disease test. Our development team continues to evaluate platforms of choice for this diagnostic test,” Jaskowiak wrote in an e-mail to BioArray News this week.
“We are experienced at using a number of array platforms in house. We designed and launched [our] Human Genome-Wide SpliceArray earlier in 2007 and felt that it was ideally suited to identify biomarkers for disease as it provides the most comprehensive analysis of the human genome,” wrote Jaskowiak. ExonHit only offers its Human Genome-Wide Splice Array on the Affy platform due to the firm’s high-density capabilities.
Jaskowiak did not provide a timeline for when the company could file a submission with the US Food and Drug Administration for 510 (k) clearance, but wrote that ExonHit is now engaged in “expanding the clinical trials to validate the test's ability to screen out patients from other forms of dementia such as frontal lobe dementias, Lewy body dementias, or vascular dementias.”
According to Jaskowiak, the clinical work is underway and will continue through the middle of next year while the company outfits its labs in Gaithersburg, Md., to operate in a Good Laboratory Practices-compliant environment to serve its pharmaceutical customers.
“Today, we have the laboratory operations infrastructure to support them and are working actively on setting up our labs to operate in a GLP-compliant environment to meet the pharmaceutical companies’ regulatory requirements,” he wrote. “Longer term, we will explore what partnerships may be required to expand the business further.”
The BioMérieux Connection
ExonHit’s Alzheimer’s test is a 60-gene expression assay that uses an algorithm to produce a score that determines whether the patient has Alzheimer's disease. While the company has partnered with Affy to produce splice arrays, it has not officially concluded an agreement with Affymetrix to develop and sell a diagnostic test on the GeneChip platform.
Jaskowiak said that while ExonHit is not currently participating in the “Powered by Affymetrix” program, “we continue to explore what business agreements make sense for the molecular diagnostics business.”
To date Affy has signed PBA partnership agreements with 11 companies in North America, Europe, and Asia. While ExonHit and Affy are not directly linked by such an agreement, ExonHit has played a role in the development of tests that are being developed for use on the Affy platform by French diagnostics firm BioMérieux.
In January, ExonHit and BioMérieux announced plans to develop a blood-based prostate-cancer screening test aimed at helping doctors weigh the risks of performing surgery to remove tumors (see BAN 1/16/2007
The two companies signed a six-year research and development agreement in 2005 and also are involved in a study for a blood-based breast cancer diagnostic and a similar program to develop a test to detect colorectal cancer.
Last January, BioMérieux spokesperson Christelle Chabert-Toujas declined to estimate when any of the tests could be available. “Our common research programs are still underway,” she wrote in an e-mail to BioArray News at the time. Chabert-Toujas did not respond to an e-mail this week seeking an update on the progress of the company’s tests.
Other Affy Tests in the Wings
In addition to BioMérieux, Affy’s PBA partners are Roche Diagnostics, which launched the AmpliChip CYP450 for drug-metabolism screening in 2005, as well as Skyline Diagnostics, Vita Genomics, Medical Prognosis Institute, Veridex, Sysmex, Epigenomics, Almac Diagnostics, and Pathwork Diagnostics (see related story, this issue
“We continue to explore what business agreements make sense for the molecular diagnostics business.”
Roche is moving forward with three more Affy-based tests, according to a company official. Lonnie Shoff, senior vice president of applied science and molecular diagnostics at Roche Diagnostics, told BioArray News in June that the company’s Leukemia AmpliChip and its p53 AmpliChip for assessing response to cancer treatment are “very far along” and could become available for clinical use by 2009.
“I know customers on the diagnostics side that have participated and used the product. So we are in a very late stage there, so that will not change,” Shoff said at the time (see BAN 6/26/2007
Roche also has a Lymphoma AmpliChip in development that will enable physicians to tell which subtype of the disease an individual patient has. Roche did not respond to an e-mail seeking an update on its AmpliChip pipeline by press time.
Other PBA partners are similarly eyeing FDA submissions in the 2008-2009 time period. According to Almac Diagnostics spokesperson Joanne McGowan, the company “is working with a number of collaborators in pharma, biotech, and academia” using the company’s Disease-Specific Arrays for colorectal cancer, breast cancer, and lung cancer as research tools “to develop further in vitro diagnostic products” on the Affy platform.
Almac currently has an ongoing collaboration with Massachusetts General Hospital in Boston and others to develop a diagnostic for colorectal cancer patients, and in August in partnered with Cancer Research UK on breast cancer work (see BAN 8/7/2007
McGowan told BioArray News in an e-mail this week that Craigavon, UK-based Almac plans to “service both European and US markets initially” and is planning both CE Marks and FDA clearance for its diagnostics. “We hope, subject to further FDA discussions, to submit the Colorectal Stage II Test for clearance sometime in 2008,” she wrote.
Affy partner Epigenomics also expects to see a diagnostic assay on the market within the next 12 months. Spokesperson Achim Plum told BioArray News in an e-mail this week that the Berlin-based company is “developing a prognostic test that predicts the likelihood of relapse of prostate cancer after radical prostatectomy.
“The test is performed on fixed and paraffin-embedded tissue samples and uses the methylation of the gene PITX2 as a proprietary biomarker,” Plum wrote. For now, Epigenomics intends to market the test in the US and the EU. In the US, it plans to place the test in a reference lab, while a CE-Marked kit is planned for the EU. Plum wrote that Epigenomics expects to begin placing the assay in US reference labs sometime next year.
Skyline Diagnostics, based in Rotterdam, The Netherlands, also plans to launch a test for Acute Myeloid Leukemia next year. The company did not respond to an e-mail seeking comment by press time.
Two Affy partners with less clear schedules include the Medical Prognosis Institute, an Åarhus, Denmark-based diagnostics shop; and Vita Genomics, headquartered in Taiwan. MPI CEO Jesper Drejet told BioArray News in an e-mail last week that the company has developed tests that predict the “prognosis of cancer patients after surgery and predict which anti-cancer therapy will work best against the individual tumor.”
According to Drejet, the assays are “currently in final clinical testing before market launch in a few years in Europe and the US.”
Vita Genomics CEO Ellson Chen told BioArray News in an e-mail this week that the firm is developing two types of assays with Affy chips. One will test for familial hypercholesterolemia patients, while the other supposedly can predict patient response to hepatitis treatment with interferon-based combination therapy.
“We are offering them to patients in Taiwan and China through major hospitals using home-brew tests from our certified reference lab,” he wrote. “Once the market gets established, we do plan to file for FDA approval. It will most likely go through collaborations with a partner towards next year.”
Affy’s other two partners, Sysmex and Veridex, are developing tests for cancer. Sysmex declined to discuss its research programs this week, while Veridex, a J&J company, did not respond to e-mails and phone calls seeking comment.