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Amped-up MDx assays
SAN DIEGO, Calif.—Quidel Corp., a provider of rapid point-of-care diagnostic tests, announced recently that it has entered into an agreement with BioHelix Corp. that aims to develop and commercialize in vitro molecular diagnostic tests utilizing BioHelix's novel isothermal amplification technology.
The partnership combines BioHelix's expertise in the research and development of nucleic acid technologies for diagnostic applications with Quidel's strengths in the development, manufacturing and commercialization of diagnostic tests.Under the partnership, Quidel and BioHelix will fund and jointly develop assays for rapid detection of infectious pathogens in a non-instrumented, handheld format utilizing BioHelix's isothermal amplification technology.BioHelix will assume primary responsibility for assay development, while Quidel will be responsible for manufacturing, marketing and selling the new products developed under the agreement and exclusive, worldwide commercialization rights for the new products. Financial terms of the agreement were not released.
According to Quidel President and CEO Douglas C. Bryant, the companies' combined expertise will offer unique MDx solutions to the decentralized testing environment. Quidel sells diagnostic products, which focus on family health areas such as pregnancy, infectious diseases, general health screening, oncology, bone health and autoimmune disorders, for use in physician's offices, hospitals, clinical laboratories and wellness screening centers.
BioHelix, a privately held molecular diagnostics company located in Beverly, Mass., specializes in the development of next-generation diagnostic solutions and nucleic acid tests based upon its isothermal nucleic acid amplification platform for infectious diseases and for genetic variations. BioHelix has developed an isothermal DNA amplification system that uses a helicase enzyme to unwind double stranded DNA (dsDNA), referred to as Helicase-Dependent Amplification. In HDA reactions, duplex DNA is separated into single strands by a helicase.
According to BioHelix, compared with the other techniques, this amplification method is closer to nature's method of performing DNA replication and it has many advantages, including low costs for instrumentation, ease of use for assay development using two primers, a versatile platform that can amplify both DNA and RNA, compatibility with multiple detection technologies, and high sensitivity and specificity.
BioHelix's isothermal amplification technology made it an attractive partner for the development and commercialization agreement, Bryant says. He notes that BioHelix is unique in combining isothermal amplification with an easy to use on-demand lateral flow detection system.
"Helicase Dependant Amplification (HAD), in a cassette format, is a novel, cost-effective, instrument-free platform which presents a unique opportunity for the development of MDx assays," says Bryant.
"Unlike conventional amplification technologies, such as the polymerase chain reaction (PCR), which requires thermocycling, HDA works at a uniform temperature, eliminating the need for complicated instrumentation," Bryant says. "Like PCR, HDA assays utilize two primers to flank the DNA fragment to be amplified, thereby allowing for simple and rapid development of new single-plex and/or multiplex assays."
Both companies are looking forward to the opportunities created by the agreement.
"We are excited to work with Quidel in the further development and commercialization of simple, cost-effective molecular diagnostic tests, which is a major focus for our company," says Dr. Huimin Kong, president and CEO of BioHelix.