DiaGenic, a Norwegian molecular diagnostics company, is validating two tests — one for early-stage breast cancer diagnosis, the other for early-stage Alzheimer’s detection — and plans to have prototypes for both ready by the end of this year, according to a company official.
Håkon Sæterøy, the company’s head of investor relations, told BioArray News this week that prototypes have been developed for both tests using Applied Biosystems’ RT-PCR TaqMan platform as well as custom CodeLink bioarrays from GE Healthcare.
The use of the TaqMan platform for the prototypes is to be expected, as DiaGenic and ABI have been partners since mid-2005. But the use of GE Healthcare’s arrays is a new step for DiaGenic, which developed its tests using Agilent chips and validated them using ABI’s Expression Analysis System. Moreover, the company is considering that the CodeLink platform may be the right one for the marketplace when it launches its tests.
To be sure, Sæterøy said DiaGenic “could develop a full product on both platforms.” He said that the decision was made to build the prototypes on the CodeLink platform to demonstrate that the company’s tests are actually platform independent. Most of the R&D work for the tests, which use peripheral blood samples, has been done using ABI’s arrays and TaqMan assays.
“We established the first prototypes to show to potential commercial partners,” he said. “It is important for us to show that it works for platforms from different vendors.”
According to Sæterøy, DiaGenic is currently testing the prototypes in-house and the results should be ready by year-end. In the firm’s third-quarter financial report, released last month, DiaGenic said that it selected Scienion, a Berlin-based array company, to run the studies on the CodeLink platform, while the TaqMan studies are being carried out DiaGenic’s lab in Oslo with equipment from ABI.
Agreements have been signed with several hospitals and clinics in the Nordic countries and in the US to obtain blood samples that will be used to further validate the tests, DiaGenic said in the report, and the company’s goal is to have at least one validated prototype for each of the two product candidates by the end of 2006.
The company has not discussed what route it will take with the tests upon commercialization.
‘All Options Open’
Rather than trying to build its own platform, DiaGenic’s strategy for marketing its genetic signature-based in vitro diagnostics has been to look for commercial partners with platforms to help bring the tests to market. In the case of the company’s breast cancer diagnostic, that partner is Agilent Technologies.
"We indeed are working with DiaGenic in the development of diagnostics for breast cancer. It's still in the research stage, DiaGenic is developing these tests, but, yes, they are using our platform," Stuart Matlow, a spokesperson for Agilent Technologies, told BioArray News in August 2005 (see BAN 8/17/2005).
However, when DiaGenic chose a platform for developing its Alzheimer’s IVD, it opted to work with ABI. Yet of the three platforms in the running, GE’s CodeLink bioarrays could prove to be the actual platform used in the final commercial product. According to DiaGenic spokesperson Richard Hayhurst, the company has not made a final decision on what platform it will choose.
“We did the original work for the breast cancer test on the Agilent platform. But GE, of course, has the potential to become a big player in diagnostics.”
“When it comes to the future platform the company wants to keep all options open,” Hayhurst told BioArray News this week. “We did the original work for the breast cancer test on the Agilent platform. But GE, of course, has the potential to become a big player in diagnostics,” he said.
Hayhurst cited the recent interest Siemens has taken in developing its diagnostics capabilities, and said that it was very possible that GE, too, could become a major player in diagnostics soon.
Last year Siemens bought German array firm Infineon in a bid to develop a line of biochip-based diagnostics (see BAN 6/15/2005). In July, Siemens also announced plans to acquire Bayer Diagnostics for $5.2 billion.
GE could not be reached for comment, but last month a company official hinted that the firm definitely considers the clinic as the next step for its CodeLink arrays.
“Our strategy going forward is essentially to focus on lower- to medium-density custom arrays and theme arrays with predetermined content,” Randall Lockner, GE senior scientist, told BioArray News last month (see BAN 10/10/2006).
According to Lockner, the firm has been developing its own assays for research usage, specifically for metabolism and women’s health studies. While the company has not publicly expressed an interest to associate with external diagnostic companies in an Affymetrix/Roche-style partnership, in which Affy produces tests on its chips for Roche using the Swiss giant’s content, Lockner confirmed an interest beyond research.
“We would imagine this moving into the clinic in the not so distant future, but not necessarily in ’07,” Lockner said at the time.