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.
The prototypes have been developed for both tests using Applied Biosystems’ RT-PCR TaqMan platform as well as custom CodeLink microarrays from GE Healthcare.
If DiaGenic chooses GE’s platform for the breast cancer test, it would signal a vote of confidence for microarrays in general, and CodeLink in particular, when used in molecular diagnostic testing. GE, however, has remained fairly quiet on its own plans for the burgeoning market.
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.
Håkon Sæterøy, DiaGenic’s head of investor relations, told BioCommerce Week sister publication BioArray News this week 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 at DiaGenic’s lab in Oslo with equipment from ABI.
Will GE Focus on Microarrays for Dx?
While DiaGenic may opt to run its tests on GE’s microarray platform, neither GE nor ABI have said that microarrays will be the technology of choice when they enter the molecular diagnostics market with their own products.
In fact, many industry experts have questioned whether microarrays are the best technology for conducting molecular diagnostics and have said that RT-PCR-based tests are likely better suited for that application.
Nonetheless, microarray market leader Affymetrix, along with partner Roche Molecular Diagnostics, won US and European approval last year to sell the CYP450 AmpliChip as an in vitro diagnostic. That product is based on Affymetrix’s GeneChip platform.
Nearly a year ago, ABI signaled its intention to push its research tools into the fast-growing molecular diagnostics field (see BioCommerce Week 1/11/2006). But it has yet to say which of its instruments will form the basis of that strategy. The firm has many to choose from, with an arsenal of thermal cyclers, microarrays, mass spectrometers, and DNA sequencers already placed in research customers’ labs.
Meanwhile, GE Healthcare has been much quieter about its plans for the market. Since naming Gene Cartwright as its president of molecular diagnostics last December, the firm has yet to say which technologies it will employ in the field. It also has been comparatively timid on the alliance and acquisition front in expanding its options for the market.
DiaGenic’s belief that GE could eventually become a major player in the clinical and molecular diagnostics market could help it decide which platform to use, though DiaGenic spokesperson Richard Hayhurst said the company has not made a final decision on what platform it will choose.
“When it comes to the future platform, the company wants to keep all options open,” Hayhurst said this week. “We did the original work for the breast cancer test on the Agilent [microarray] platform. But GE, of course, has the potential to become a big player in diagnostics,” he said.
Hayhurst cited recent moves in the diagnostics space taken by GE rival Siemens in developing its diagnostics capabilities, and suggested 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, and followed that move with the roughly $2-billion acquisition of Diagnostic Products Corp. this past April.
But Siemens’ biggest splash came this summer when it agreed to acquire Bayer Diagnostics for $5.26 billion — a purchase that catapults the firm into a top-three molecular diagnostic player (see BioCommerce Week 7/5/2006).
GE has thus far resisted such dramatic efforts to become more involved in the clinical and molecular diagnostics fields.
“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.”
The firm could not be reached for comment by press time, but last month a company official hinted that GE 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 use, specifically for metabolism and women’s health studies. While the company has not publicly expressed an interest to collaborate with external diagnostic companies in an Affymetrix/Roche-style partnership, 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.
GE also began collaborating earlier this year with the Translational Genomics Research Institute to identify and characterize cancer-associated genes that could be used to target drugs (see BioCommerce Week 7/12/2006). The partners are using GE’s IN CELL 1000 and 3000 cell analyzers in the project, the results of which they hope will be applied to personalized medicine.
The TGen collaboration "really dovetails into our key initiatives in working in this space," Mike Honeysett, manager of strategic alliances for GE Healthcare Life Sciences, told BioCommerce Week at the time. "GE Healthcare has decided that translational medicine, or personalized medicine, is really a key focus for the entire product line going from clinical diagnostics all the way upstream to proteomics and genomics.”
When GE Healthcare does become more involved in the molecular diagnostics space, it will see some pretty familiar competitors. The firm’s rivals in the microarray and sequencing spaces, such as ABI, Agilent, Affymetrix, and Beckman Coulter, all have plans to enter the molecular diagnostics market. In addition, GE’s chief competitors in the medical imaging field, including Siemens, Philips, and Hitachi, have either already entered or signaled their intentions to enter the market.
— Justin Petrone contributed to this article.