Amped-up MDx assays

Quidel, BioHelix in deal to develop in vitro molecular diagnostic tests

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SAN DIEGO, Calif.—Quidel Corp., a provider of rapidpoint-of-care diagnostic tests, announced recently that it has entered into anagreement with BioHelix Corp. that aims to develop and commercialize invitro molecular diagnostic tests utilizingBioHelix's novel isothermal amplification technology.
The partnership combines BioHelix's expertise in theresearch and development of nucleic acid technologies for diagnosticapplications with Quidel's strengths in the development, manufacturing andcommercialization of diagnostic tests.Under the partnership, Quidel andBioHelix will fund and jointly develop assays for rapid detection of infectiouspathogens in a non-instrumented, handheld format utilizing BioHelix'sisothermal amplification technology.BioHelix will assume primaryresponsibility for assay development, while Quidel will be responsible formanufacturing, marketing and selling the new products developed under theagreement and exclusive, worldwide commercialization rights for the newproducts. Financial terms of the agreement were not released.
According to Quidel President and CEO Douglas C. Bryant, thecompanies' combined expertise will offer unique MDx solutions to thedecentralized testing environment. Quidel sells diagnostic products, whichfocus on family health areas such as pregnancy, infectious diseases, generalhealth screening, oncology, bone health and autoimmune disorders, for use inphysician's offices, hospitals, clinical laboratories and wellness screeningcenters.
BioHelix, a privately held molecular diagnostics companylocated in Beverly, Mass., specializes in the development of next-generationdiagnostic solutions and nucleic acid tests based upon its isothermal nucleicacid amplification platform for infectious diseases and for genetic variations.BioHelix has developed an isothermal DNA amplification system that uses ahelicase enzyme to unwind double stranded DNA (dsDNA), referred to asHelicase-Dependent Amplification. In HDA reactions, duplex DNA is separatedinto single strands by a helicase.
 According to BioHelix, compared with theother techniques, this amplification method is closer to nature's method ofperforming DNA replication and it has many advantages, including low costs forinstrumentation, ease of use for assay development using two primers, aversatile platform that can amplify both DNA and RNA, compatibility withmultiple detection technologies, and high sensitivity and specificity.
BioHelix's isothermal amplification technology made it anattractive partner for the development and commercialization agreement, Bryantsays. He notes that BioHelix is unique in combining isothermal amplificationwith an easy to use on-demand lateral flow detection system.
"Helicase Dependant Amplification (HAD), in a cassetteformat, is a novel, cost-effective, instrument-free platform which presents aunique opportunity for the development of MDx assays," says Bryant.
"Unlikeconventional amplification technologies, such as the polymerase chain reaction (PCR),which requires thermocycling, HDA works at a uniform temperature, eliminatingthe need for complicated instrumentation," Bryant says. "Like PCR, HDA assaysutilize two primers to flank the DNA fragment to be amplified, thereby allowingfor simple and rapid development of new single-plex and/or multiplex assays."
Both companies are looking forward to the opportunitiescreated by the agreement.
"We are excited to work with Quidel in the furtherdevelopment and commercialization of simple, cost-effective moleculardiagnostic tests, which is a major focus for our company," says Dr. HuiminKong, president and CEO of BioHelix.

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