Per the terms of the transaction, Quidel will make a cashpayment of $10 million to BioHelix's shareholders, as well as additionalamounts linked to a research and development earn-out based on the completionof a specified number of assays, and a commercial earn-out based on productsales over a specified period.
This transaction is not the first time Quidel and BioHelixhave crossed paths. The two companies announced a joint development andcommercialization agreement in October 2009 to develop and commercialize in-vitro molecular diagnostic testsusing BioHelix's isothermal amplification technology. The agreement called forQuidel to fund and jointly develop assays with BioHelix for the rapid detectionof infectious pathogens in a non-instrumented, handheld format. BioHelix wasprimarily responsible for developing the assays while Quidel was primarily incharge of manufacturing, marketing and selling the resulting products.
"The collaboration between BioHelix and Quidel has beeneffective and productive. Further, with the launch of AmpliVue C. difficile, we have demonstratedcustomer receptivity to a handheld, disposable molecular platform, which givesus confidence that this additional investment in BioHelix and its isothermalamplification technology is warranted," Douglas Bryant, president and CEO ofQuidel, commented in a press release regarding the transaction. "[HelicaseDependent Amplification] provides both speed and ease of use withoutsacrificing sensitivity or specificity, and we believe this technology will notonly benefit AmpliVue, but Project Wildcat as well."
BioHelix has developed two isothermal amplificationplatforms: the target-based Helicase Dependent Amplification (HDA) platform andthe primase-based Whole Genome Amplification (pWGA) platform. BioHelix's HDAtechnology uses a helicase enzyme to unwind double-stranded DNA, which offershigh sensitivity and specificity as well as low cost since it eliminates theneed for a thermocycler. In addition, the HDA method can amplify both DNA andRNA. The pWGA technology was licensed from Harvard University, and as BioHelixnotes on its website, "typically are used for amplifying total genomic DNA forarchiving as well as for downstream analysis, including genotyping, forensics,comparative genomic hybridization and single-cell analysis."
The company's product offerings include its IsoAmp HSV Assayfor the detection of Herpes simplexvirus (HSV1 and HSV2), and a trio of kits based on its HDA and pWGAplatforms—Rapisome pWGA kit for whole-genome amplification, IsoAmpII tHDA kitfor target sequence amplification and IsoAmpIII tHDA kit for robust targetamplification. BioHelix also offers Primer Navigator DNA amplificationEnhancers designed to improve nucleic acid amplification reactions.
Quidel now plans to accelerate development of its AmpliVueisothermal assays, in addition to lowering their associated manufacturingcosts. Quidel currently markets its AmpliVue C. difficile Assay, which features easy-to-read disposablecassette-based molecular testing, with minimal hands-on time, lyophilizedreagents and a total assay time of roughly 80 minutes. The assay was grantedclearance from the U.S. Food and Drug Administration in December 2012.BioHelix's product portfolio will complement Quidel's offerings, which includeits own HSV assay, as well as products for detecting and diagnosing diseasesand conditions such as influenza, Strep A, herpes, pregnancy, respiratorysyncytial virus and thyroid disease.
BioHelix was founded in 2004 as a spin-off of New England Biolabs Inc.Following the acquisition, BioHelix will be operated as a wholly ownedsubsidiary of Quidel, and Dr. Huimin Kong will remain BioHelix's president.
Neither company responded to requests for additionalinformation.
"We welcome Dr. Kong, BioHelix and its employees to theQuidel family, and are excited to add isothermal molecular assay developmentand enzyme manufacturing to our growing list of core competencies," saidBryant.