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Doubting Microarrays’ Future in Molecular Dx, GE Plans to Drop CodeLink Arrays Next Year

GE Healthcare, abandoning hope of a profitable future for the product line, will stop making its CodeLink printed bioarrays by April 2007 and will stop accepting requests from existing customers in February, the company told BioCommerce Week sister publication BioArray News this week.
 
The company’s doubts about using microarray technology for molecular diagnostic applications was a key reason for its decision and adds further weight to those who believe RT-PCR will be the technology of choice in the molecular diagnostics field.
 
GE has not indicated that it will sell its assets related to the CodeLink business, but said it will help clients switch to rival platforms as CodeLink is phased out, leaving the future of the 7-year-old microarray technology in doubt.
 
A GE spokesperson said there are several reasons GE decided to stop producing the printed array slides, “one of which is that the majority of future molecular diagnostics products will use technologies other than microarrays primarily due to the small number of genes that will need to be measured for most clinical molecular diagnostics applications." 
 
CodeLink is “designed to measure thousands of genes, and thus cannot compete with the cost and ease-of-use attributes required to succeed in future clinical molecular diagnostics,” she said.
 
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.
 
Affy also recently filed applications with the state of California and the US Food and Drug Administration to enable patient testing in its newly developed clinical laboratories, which uses the firm’s microarray technology (see BioCommerce Week 11/8/2006).
 
Nearly a year ago, Applied Biosystems 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.
 
GE Healthcare has been much quieter about its plans for the molecular diagnostics market. Since naming Gene Cartwright as its president of molecular diagnostics a year ago, 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.
 
Meanwhile, other microarray firms including CombiMatrix, Osmetech, and Nanogen have begun array-based efforts in the molecular diagnostics market. And several molecular biology tool providers, including Qiagen, PerkinElmer, Invitrogen, and Luminex, have decided that bead-based multiplexing is a viable option for molecular diagnostics (see related article).
 
But among the dozens of firms hoping to jump into the molecular diagnostics field, the primary choice of platform still appears to be RT-PCR. One such company is Beckman Coulter, which recently said that it plans to launch a next-generation, RT-PCR-based molecular diagnostics platform around 2010 (see BioCommerce Week 12/6/2006).
 
Short of Expectations
 
The decision to scuttle CodeLink comes at a time when GE’s array unit was branching out into content-specific and customizable arrays and building its service infrastructure. Now many of GE Healthcare’s existing customers believe they will be forced to adopt rival platforms, such as those made by Agilent, ABI, Illumina, and market leader Affy.
 
According to a GE spokesperson, in the nearly three years since GE Healthcare obtained CodeLink through its acquisition of Amersham BioSciences, “GE has invested in the CodeLink business with the goal to bring a differentiated product to the research segment and establish a significant position in the microarray research market.”  However, the company said it was not confident in the future viability of the product line.
 
“Unfortunately, while we believe we have delivered a high-quality product, our prospects to profitably grow this product long-term have fallen short of expectations, and as a result GE has decided to discontinue the CodeLink printed microarray product line during early 2007,” the spokesperson said.
 

CodeLink is “designed to measure thousands of genes, and thus cannot compete with the cost and ease-of-use attributes required to succeed in future clinical molecular diagnostics.”

She added that GE will continue to manufacture and sell CodeLink activated blank slides for homebrew microarrays indefinitely.
 
The company will support all of its current customers and will serve researchers who are using CodeLink until they finish their projects, the spokesperson said. At that point CodeLink sales representatives will contact customers to help them transition to alternative platforms from competitors. 
 
GE Healthcare has not announced its intentions for CodeLink once it is wound down. The spokesperson said that it is possible that GE could put the CodeLink portfolio on the block, but so far the company has only decided to discontinue making and selling pre-printed arrays.
 
Scott Magnuson, a former developer of the CodeLink technology at Motorola Life Sciences and currently CEO of microarray services provider GenUs Biosystems, said that GE perhaps did not do enough to sell the technology after it acquired it with Amersham.
 
“I am not confident that GE did a great job marketing it and selling it,” said Magnuson. “From what I understand CodeLink was really turning the corner with regards to cost and data.”
 
Magnuson suggested it was not too late for another company to step in and save the technology, offering Invitrogen, Qiagen, and Eppendorf as companies that could show interest.
 
Earlier this year, Invitrogen, which sells oliogonucleotides and protein arrays, licensed non-exclusive, worldwide license to a number of Affymetrix's microarray patents (see BioCommerce Week 6/21/2006). The firm has been tight-lipped about which patents it licensed and whether it intends to expand into the field of DNA microarrays, but it is clear the firm intends to expand its franchise in the non-coding RNA tools market.
 
However, Qiagen officials previously told BioCommerce Week that becoming a microarray manufacturer and seller is not part of the firm’s plans. Instead, it has focused on providing complementary technologies and sample preparation tools to microarray partners.
 
Edward Winnick contributed to this article.

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