Norwegian life sciences company DiaGenic announced last week that it has hired British genetic-testing start-up Opaldia to sell its genetic tests in the UK.
The alliance will begin sometime next year with DiaGenic’s RT-PCR-based early-stage breast cancer assay after the product wins CE Marking.
DiaGenic’s breast cancer test, which runs on Applied Biosystems’ TaqMan platform, will complement Agendia’s MammaPrint microarray-based breast cancer-recurrence test, which Opaldia also sells.
DiaGenic has developed a prototype of the breast cancer test that runs on Applied Microarrays’ CodeLink platform, but CEO Erik Christensen told BioArray News in an e-mail this week that the firm is currently “sticking to ABI” for its breast cancer product.
Terms of the deal with DiaGenic enable Opaldia to market a research-use-only version of the test until it receives a CE Mark. The company also has exclusive rights to sell additional tests made by DiaGenic as they become available, including an assay for early-stage Alzheimer’s disease, which the company expects to be approved in the EU during the second half of 2008.
According to Christensen, the assay, which looks for biomarkers in peripheral blood samples, could help oncologists confirm the presence of the disease before it shows up on a mammogram.
“This is particularly important in younger women with dense breasts where mammography has low accuracy,” Christensen said.
Though its breast cancer assay runs exclusively on ABI’s platform, DiaGenic’s prototype Alzheimer’s assay has been developed to work on both the TaqMan platform and the CodeLink platform (see BAN 6/12/2007).
Christensen added that DiaGenic, eager to reach additional European markets, plans to pen more marketing and distribution deals similar to the one with Opaldia. He said the firm has contacted “several potential partners that have shown interest in our technology and assays but no agreements have been signed. This work will be intensified next year.”
The UK Market
Working with DiaGenic will also boost Opaldia’s menu. Founded in 2006, the London-based firm seeks to offer innovative tests to private clinics in order to build up the evidence necessary to have the assays widely adopted by the UK’s National Health Service.
According to James Mackay, the firm’s medical director, it made sense to adopt DiaGenic’s test because it strengthens its breastcare program, which offers risk assessment, screening, and support. ”This blood test will help women with difficult mammograms,” he told BioArray News this week. ”I have been looking for 10 years for a decent blood-based test for breast cancer and we haven’t found it until we met up with DiaGenic.”
Mackay, a former NHS oncologist, added that Opaldia’s clinical specialty is breast cancer but that the company is open to selling genetic tests for other disease states, including Alzheimer’s, to other private clinics.
“The main difficulty with the NHS is that in adopting technology, they are very slow for both good and bad reasons.”
“My view is that we are a clinical company; we have established credentials via our breast program,” he said. ”We will sell [other] tests to working doctors.”
According to Mackay, the initial market for DiaGenic’s test in the UK will be women in their early 40s who are interested in a mammography but who have dense breasts that make it difficult to detect early-stage cancer. He estimated that about 50 percent of women in that age group fit this description.
Opaldia will initially offer the test together with mammography. “It would be a question of having a mammography, and if it’s dense we would have the blood test,” he said.
Aiding in the adoption of the test is the fact that DiaGenic’s test will cost roughly as much as a mammography in the UK, Mackay said. The test is expected to sell for between £200 ($404) and £500 whereas a mammography typically costs around £250.
By comparison, Opaldia charges £1,650 for Agendia’s array-based MammaPrint test, which uses a 70-marker gene signature to assess the risk for breast cancer recurrence (see related story, this issue).
Mackay said that the goal is to build enough credibility for both the array-based and RT-PCR-based tests that it will be easier for the NHS to adopt the technology. “The main difficulty with the NHS is that in adopting technology, they are very slow for both good and bad reasons,” he said.
“We would offer these tests in [the] private sector and help in building the evidence base required to persuade the NHS to adopt them,” he said.
Next Stop, India
Another country that is likely to launch DiaGenic’s breast cancer assay is India. According to Christensen, the company has been working with a confidential independent lab in India that works with its Oslo R&D team on validating signatures.
Christensen said that a study in India validating the breast cancer test will wrap up in January. Data from the study will be presented in India in February, and DiaGenic expects to launch the assay in India in mid-2008. Christensen said his company is currently in discussions with potential local distributors.
In its third-quarter financial report published in October, DiaGenic noted that “meetings have been held with several major Indian laboratory chains, independent laboratories, and pharmaceutical companies to prepare for the commercial launch of the test for breast cancer in India” next year.
The company said the talks have “clearly confirmed the need for improved diagnostics in India and have resulted in several negotiations.”