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Quidel acquires BioHelix Corp.
June 2013
by Kelsey Kaustinen  |  Email the author


SAN DIEGO—Quidel Corp., a manufacturer of diagnostic healthcare solutions, has announced the completion of its acquisition of Beverly, Mass.-based BioHelix Corp., which develops nucleic acid technologies for molecular diagnostic tests.  
Per the terms of the transaction, Quidel will make a cash payment of $10 million to BioHelix's shareholders, as well as additional amounts linked to a research and development earn-out based on the completion of a specified number of assays, and a commercial earn-out based on product sales over a specified period.  
This transaction is not the first time Quidel and BioHelix have crossed paths. The two companies announced a joint development and commercialization agreement in October 2009 to develop and commercialize in-vitro molecular diagnostic tests using BioHelix's isothermal amplification technology. The agreement called for Quidel to fund and jointly develop assays with BioHelix for the rapid detection of infectious pathogens in a non-instrumented, handheld format. BioHelix was primarily responsible for developing the assays while Quidel was primarily in charge of manufacturing, marketing and selling the resulting products.
"The collaboration between BioHelix and Quidel has been effective and productive. Further, with the launch of AmpliVue C. difficile, we have demonstrated customer receptivity to a handheld, disposable molecular platform, which gives us confidence that this additional investment in BioHelix and its isothermal amplification technology is warranted," Douglas Bryant, president and CEO of Quidel, commented in a press release regarding the transaction. "[Helicase Dependent Amplification] provides both speed and ease of use without sacrificing sensitivity or specificity, and we believe this technology will not only benefit AmpliVue, but Project Wildcat as well."  
BioHelix has developed two isothermal amplification platforms: the target-based Helicase Dependent Amplification (HDA) platform and the primase-based Whole Genome Amplification (pWGA) platform. BioHelix's HDA technology uses a helicase enzyme to unwind double-stranded DNA, which offers high sensitivity and specificity as well as low cost since it eliminates the need for a thermocycler. In addition, the HDA method can amplify both DNA and RNA. The pWGA technology was licensed from Harvard University, and as BioHelix notes on its website, "typically are used for amplifying total genomic DNA for archiving 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 Assay for the detection of Herpes simplex virus (HSV1 and HSV2), and a trio of kits based on its HDA and pWGA platforms—Rapisome pWGA kit for whole-genome amplification, IsoAmpII tHDA kit for target sequence amplification and IsoAmpIII tHDA kit for robust target amplification. BioHelix also offers Primer Navigator DNA amplification Enhancers designed to improve nucleic acid amplification reactions.  
Quidel now plans to accelerate development of its AmpliVue isothermal assays, in addition to lowering their associated manufacturing costs. Quidel currently markets its AmpliVue C. difficile Assay, which features easy-to-read disposable cassette-based molecular testing, with minimal hands-on time, lyophilized reagents and a total assay time of roughly 80 minutes. The assay was granted clearance from the U.S. Food and Drug Administration in December 2012. BioHelix's product portfolio will complement Quidel's offerings, which include its own HSV assay, as well as products for detecting and diagnosing diseases and conditions such as influenza, Strep A, herpes, pregnancy, respiratory syncytial 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 owned subsidiary of Quidel, and Dr. Huimin Kong will remain BioHelix's president.   Neither company responded to requests for additional information.
"We welcome Dr. Kong, BioHelix and its employees to the Quidel family, and are excited to add isothermal molecular assay development and enzyme manufacturing to our growing list of core competencies," said Bryant.
Code: E061319



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