By Ben Butkus
Biosearch Technologies has granted a license to molecular diagnostics firm Intelligent Medical Devices, or IMDx, for patents related to Biosearch's fluorophores and dark quencher dyes, the companies said this week.
In addition, Biosearch will manufacture cGMP oligonucleotides for Intelligent Medical Devices for use in PCR-based human in vitro diagnostics, which IMDx designs and develops using its proprietary bioinformatics platform.
Biosearch's products will also be incorporated into a variety of molecular diagnostic assays that IMDx is developing in collaboration with Abbott under a previous agreement, IMDx Chairman and CEO Alice Jacobs said this week.
The licensing agreement between Biosearch and IMDx covers patents related to Biosearch's CAL Fluor and Quasar fluorophores and Black Hole Quencher dark quencher dyes, which are being used in the development of several commercial molecular diagnostic assays.
Financial terms of the agreement were not disclosed.
"We think they're very effective for the detection we're going to be utilizing," Jacobs told PCR Insider this week. "I think it's pretty standard [to use these dyes] across real-time PCR systems. We've done a lot of work evaluating dyes, and there are a lot out there, but we particularly like these."
Biosearch has licensed its fluorophores and dark quencher dyes to several other companies, including Micronics, Seegene, and DuPont Qualicon, for use in PCR-based molecular tests. The Novato, Calif.-based company is also in the midst of a pair of lawsuits, still ongoing, with Life Technologies, which claims that various Biosearch fluorescent energy transfer-labeled oligonucleotides and quencher dyes infringe upon certain patents owned by Life Tech (PCR Insider, 1/6/20110).
Privately held IMDx, based in Cambridge, Mass., uses a bioinformatics process to predict success or failure of molecular diagnostic tests through the simulation of real-life conditions such as contamination or genetic mutations, which can impact a test’s clinical performance.
The company's pipeline includes proprietary real-time PCR-based tests, both singleplex and multiplex, for a wide range of human diseases. The company has built a product candidate portfolio through internal discovery, and is advancing these candidates through in-house R&D.
"We have a very broad portfolio of assays in various stages of development," Jacobs said. The majority of these tests are for infectious diseases, Jacobs said, but the company has also developed some tests in the oncology arena.
"Our bioinformatics system enables us to improve everything from sample prep and extraction to the assay design and development … and the design of oligos, primers, and probes, are incorporated in that," Jacobs said. "The goal is to really try and take as much of the guesswork out of the game of developing assays, and really be able to, in silico, verify the performance of tests before we even get into the wet lab."
Once IMDx runs potential tests through its bioinformatics process, the company also has ISO 13485 and US Food and Drug Administration Quality Systems Regulation-approved laboratories and manufacturing facilities to test and manufacture its tests, Jacobs said.
"Basically our intent is that all of the molecular assays in our product development pipeline are being designed and manufactured to incorporate the Biosearch dyes that we licensed," Jacobs said. "We believe that they can help us to develop differentiated products for many markets, and that includes a number of tests that we are developing in concert with Abbott."
In January, IMDx said that it had entered into a worldwide agreement with Abbott to design, develop, manufacture, and seek regulatory clearance for assays to be run on Abbott's FDA-cleared m2000 instrument system, an automated system for DNA and RNA testing that comprises the m2000sp module for automated sample extraction preparation and the m2000rt instrument for real-time PCR detection and analysis.
That agreement covers tests for Clostridium difficile, vancomycin-resistant Enterococci, Group B Streptococci, influenza A/B, and herpes simplex virus 1 and 2. In addition, the agreement covers tests for determining viral load for Epstein-Barr virus and BK virus outside the US.
Biosearch will also be manufacturing cGMP oligonucleotides for IMDx to use in these and other tests under development.
Jacobs said that IMDx will likely use only Biosearch's dyes and oligos in its tests, although it may also incorporate some dye and PCR technologies that may not require licenses.
"All of our IP has been developed organically, and we seek partners when we want to be able to expand our capacity and our capabilities, to make sure our tests provide the highest quality results," she said.
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