INDUSTRY NEWS
Invitrogen (Carlsbad, CA) concluded a busy four-month stretch of business with its first molecular diagnostics partnership based on the company's LUX technology. The company signed a licensing agreement with Prodesse (Waukesha, WI) for the first assays using the technology.
The Wisconsin firm specializes in the development of analyte specific reagents for use by CLIA-certified laboratories in detecting infectious-disease pathogens. Andy Shrago, Prodesse's senior vice president of sales and chief marketing officer, says his company "is just about to take the first product to the validation process" within two to three months. The product will be a real-time test for diagnosing respiratory problems, he says.
Announced in July, the deal with Prodesse follows a string of three announcements that began this past April, when Invitrogen signed a collaborative agreement with Signalomics (Steinfurt, Germany) to develop nanocrystal reagents for enhanced identification of tumors. The so-called nanotechnology approach can detect the presence of a single cancerous cell, according to the partners.
Two other collaborations came in subsequent months. In mid-June, Invitrogen agreed to supply reagents for sequencing, gene expression, and small RNA analysis kits made by Solexa (Cambridge, U.K.) for Solexa's Genome Analysis System. Later that same month, the California company and Cellartis (Gothenburg, Sweden) said they would develop novel engineered human embryonic stem cell reporter lines. The lines will offer scientists a readout that will enable them to track stem cell differentiation into different lineages for the first time, according to the companies.
Invitrogen's partnership with Prodesse marks the first agreement between the two companies. "We think what they're trying to do is the perfect place to utilize our technology," says Amy Butler, vice president, gene expression profiling, at Invitrogen. She says the company expects to make more partnership announcements during the next two quarters. Butler declined to divulge the dollar value of the Prodesse collaboration.
Invitrogen claims its LUX, or Light Upon eXtension, reagents offer better sensitivity and specificity than traditional analytical methods. "The design flexibility is really the ability to use LUX on essentially any real-time platform instrument that you'd like," says Sallie Cassell, Invitrogen's business area manager, gene regulation.
LUX primer sets for infectious agents are designed to offer specific qPCR pathogen analysis, according to the company. Prodesse's new product will "probably be a qPCR type of assay," Cassell says.
The technology also offers licensing and cost benefits as well, Invitrogen says. The proprietary technology gives Invitrogen "the freedom to operate with all the technology that Prodesse is utilizing." She notes that costly licensing fees can hinder companies seeking collaborations of the type signed by Invitrogen and Prodesse. In this instance, "all of it is proprietary Invitrogen technology, and we were able to work with Prodesse to put together an agreement that was reasonable for both parties."
Shrago says the "predominant system" used in this type of diagnostic products are TaqMan probes made by Roche Diagnostics, which owns the IP. The probes work well but carry "a fairly high royalty rate." In contrast, "the LUX has a significantly lower royalty amount," he says.
Invitrogen's product description says LUX fluorogenic assays consist of a primer labeled with a single fluorescent molecule and a corresponding unlabeled primer. Both primers are "custom synthesized according to the DNA/RNA of interest."
The benefits of real-time assays are that they reduce the number of steps from start to finish for next-generation PCR using "simultaneous amplification and detection," Shrago points out. Compared with standard PCR methods using a thermocycler, "we've heard anywhere from three to four hours from start to finish" for the real-time product.
Shrago says the upcoming products from Prodesse will be sold to "high-complexity, larger hospitals that handle molecular diagnostics." He estimates the price per test will range between $25 and $40. "These are very rough numbers," he emphasizes.
Shrago says Prodesse is pleased with the first-time collaboration: "We're happy to have the arrangement, we're happy with the technology, and we're happy to get the first products."
