18 May EraGen cystic fibrosis test to be distributed worldwide through Bayer
EraGen Biosciences in Madison landed an exclusive worldwide distribution agreement for its new cystic fibrosis assay, MultiCode PLx, to the Diagnostics Division of Bayer HealthCare LLC.
The new assay can be automated for mutation carrier screening and neonatal and newborn testing. The agreement also allows Bayer HealthCare to offer several assays for other diseases to the genetics-based diagnostics testing market, EraGen said.
Irene Hrusovsky, CEO of EraGen, declined to disclose the exact financial terms of the agreement, but did feel it was fair to say expectations for the partnership were for “a multimillion dollar opportunity for EraGen.”
EraGen pioneered its core technology – an expanded genetic information system, or AEGIS, which is a molecular diagnostics technology platform that enlarged the genetic alphabet from the two DNA base pairs found in nature to six pairs by developing eight new synthetic bases. Those new bases have enabled EraGen to invent simpler, more accurate diagnostic tests. The tests can be automated, then quickly developed and deployed to detect contagions such as SARS.
The company offers two patented platform technologies based on AEGIS, the PLx and MultiCode RTx, which the company used recently to develop a test for SARS in the U.S., just seven days after the public release of the SARS genetic code.
Hrusovsky said that the ability to fully automate the test and its short turnaround time in the lab – about three hours – represent the two key steps forward for the product.
“Efficiency in the laboratory is extraordinarily important,” Hrusovsky said. “I think the company very much had a vision that this was the market opportunity. As we’ve designed these technologies over the past several years – envisioning them, patenting these technologies and really turning them into products – they were really driven by the push toward automation, decreased hands-on time, and less involvement of very skilled workers.”
This latest agreement is but the next time in a continuing relationship between the two companies: Bayer has incorporated EraGen’s core technology into its own proprietary applications for HIV and hepatitis tests. Those applications have FDA approval and have been on the market for about five years.
Hrusovsky said the actual reagent platform system itself has been in development for the past several years, and the specific cystic fibrosis application as it applies to the Bayer agreement has been in development for the past year.
“We’ve been working with them on these agreements for a while,” Hrusovsky said.