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Life Tech to Market Quidel's PCR-Based Infectious Disease Dxs in Europe

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By Ben Butkus

Life Technologies said today that it has inked an agreement with Quidel to distribute and commercialize four of Quidel's molecular diagnostic assays for use on Life Tech's Applied Biosystems-branded 7500 family of PCR systems in Europe, beginning next month with Quidel's influenza and human metapneumovirus kits.

The agreement provides Quidel a clearer path to market for its nascent portfolio of real-time PCR-based molecular diagnostic tests, part of the company's "open box" initiative to develop such kits for use on existing testing platforms, and one facet of the company's three-part molecular diagnostics strategy.

Meantime, Life Tech said the deal represents its continued growth into the diagnostics space.

Life Tech estimates that around ten percent of its current revenues — or around $360 million for 2010 — are from molecular diagnostics. "We expect that percentage to grow significantly in the next several years as we expand our presence in the diagnostics arena," Kim Caple, head of molecular diagnostics at the company, said in a statement.

Under the agreement, Life Tech will sell Quidel's assays in Europe, where it has a broad, established distribution network, the company said. Beginning in October, Life Technologies will distribute the Quidel Molecular Influenza A+B Real-Time RT-PCR Assay and hMPV kits to European markets.

A spokesperson for Life Tech told PCR Insider in an e-mail that "the current agreement specifically calls for exclusive distribution for four assays to [Applied Biosystems] real-time instrument customers in the EU with the exception of Germany, and the contract doesn't consider the ability to distribute future assays."

Separately this week, Quidel announced that its real-time PCR-based hMPV kit has received the CE Mark. The company's real-time PCR assay for influenza A and B garnered CE Marking last month (PCR Insider, 8/10/11).

Both kits offer both performance benefits and workflow benefits over currently available tests, Life Tech said, citing one internal trial with more than 600 samples showing Quidel's influenza kit to be more sensitive and specific than an unnamed comparator assay.

Life Tech also said that Quidel has improved the workflow of these assays with refrigerated storage rather than freezer storage; one-step reagent setup; and fast qPCR cycling resulting in answers 75 minutes after sample preparation.

Both kits are for use with Life Tech's 7500 family of PCR Instruments, including the 7500 Fast Dx and the 7500 Real-Time PCR System, which the company said are installed in "hundreds of clinical diagnostic labs across Europe."

San Diego-based Quidel's open box initiative is one prong of a three-pronged strategy by the company to penetrate the molecular diagnostics market. Open box describes the company's efforts to develop PCR-based diagnostic test kits for infectious disease for use on other companies' molecular testing platforms.

In addition to the Life Tech ABI 7500 instruments, Quidel has said that it would be submitting test kits for use on Cepheid's SmartCycler for regulatory approval.

On other molecular diagnostic fronts, Quidel is working with BioHelix to develop in vitro molecular diagnostic tests for infectious pathogens in a non-instrumented, disposable platform; and is collaborating with Northwestern University to develop an integrated, low-cost molecular testing platform that will automate extraction, amplification, and detection.

Later this year, Life Technologies and Quidel expect to launch additional infectious disease kits in Europe, Life Tech said. A Life Tech spokesperson declined to share details on future areas of assay development. However, Quidel President and CEO Doug Bryant said during the company's second-quarter earnings call last month that Quidel is also developing open box tests for respiratory syncytial virus, herpes simplex virus, varicella-zoster virus, and Clostridium difficile(PCR Insider, 8/4/11).


Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.

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