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Smiths Detection and Novartis to Develop Infectious Disease Dxs Based on LATE PCR Tech

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By Ben Butkus

Smiths Detection said today that its diagnostics business has signed a collaboration and license agreement with Novartis Diagnostics to develop diagnostic tests based on Smiths' clinical diagnostics system and linear-after-the-exponential, or LATE, PCR technology.

Together, Smiths and Novartis plan to develop and market highly multiplexed assays for a variety of infectious diseases, beginning with a focus on healthcare-associated infections, officials from the companies said.

Under the terms of the agreement, Smiths will develop and manufacture diagnostic tests based on LATE PCR technology and designed to run on its Bio-Seeq molecular diagnostics instrument platform.

Novartis, meantime, will be responsible for clinical trials, regulatory affairs, sales, and marketing. Financial terms of the agreement were not disclosed, but Smiths said that payments will be linked to product-development and commercial milestones.

Smiths Detection historically has developed threat detection and screening technologies for military, transportation, homeland security, and resilience applications.

However, in the early 2000s, seeking a PCR technology for endpoint rather than real-time detection for biological detection applications, Smiths came across the LATE-PCR technology in the lab of Larry Wangh at Brandeis University.

In 2005, Smiths obtained an exclusive worldwide license with sublicensing rights to the technology from Brandeis University; and in 2008 it created Smiths Detection Diagnostics to develop veterinary and point-of-care human diagnostics based on LATE-PCR.

In LATE-PCR only one side of a DNA duplex is amplified, resulting in a high proportion of single-stranded DNA, which allows probing over a much wider temperature range —and thus a greater degree of multiplexing — than is possible with symmetric PCR, the company said.

Other advantages of the technology include faster thermocycling, better integrity of amplification, increased sensitivity due to decreased background fluorescence, and linear kinetics with little scatter among replicates, which provides quantitative endpoint analysis.

Smiths initially developed its Bio-Seeq thermocycler platform for biological threat detection, and more recently added sample-preparation capabilities for veterinary and human diagnostic applications.

The current platform features five or more independent thermocyclers, fully automated sample preparation and analysis, and a touch-screen display. According to the company, a hallmark of the platform is that it requires little training and no expertise in microbiology to operate, and takes 60 to 90 minutes to run a test from sample to result.

With all the pieces in place, Smiths then focused on enlisting the help of an experienced diagnostic developer to bring tests to market.

"We're not a conventional diagnostics company – we're part of a larger company that focuses on security" and other applications, William Mawer, president of Smiths Detection Diagnostics, told PCR Insider. "There comes a point where you realize you need some help. We're very comfortable developing the platform technology. The thing that would be a step too far for us was when this moved out into clinical development."

A little under a year ago, which is around the time it was securing the LATE-PCR technology license from Brandeis, Smiths began looking for a diagnostics-development partner, and quickly received some "fairly specific interest" from Novartis, Mawer said.

Mawer declined to identify which infectious disease areas Smiths and Novartis would target initially, deferring instead to Novartis. However, he did say that the partners had "a pretty well-defined product strategy" which will involve "putting together highly multiplexed single-tube assays."

Peter Maag, President of Novartis Diagnostics, wrote in an email to PCR Insider that "initial efforts will focus on addressing the critical need for tests that allow healthcare providers to more rapidly identify and treat healthcare-associated infections." Novartis Diagnostics has traditionally focused on nucleic acid testing for blood screening, and will continue to evaluate technologies to further its work in that area, Maag said.

In the LATE-PCR and Bio-Seeq technologies, Novartis sees a platform "that could serve as an important foundation for our infectious disease portfolio for a variety of reasons," Daniel Parera, head of development at Novartis Diagnostics, wrote in an e-mail.

"These include its closed system design, proven ease of use, and robust performance in demanding field-based point-of-care settings," Parera added. "It also offers speed, reliability, quantitation, and excellent potential for multiplex testing."

Further elaborating, Parera said that the technology also has improved specificity, ease, and reliability of multiplex testing by suppressing all types of mis-priming, such as primer dimers and errors during sample preparation, exponential amplification, liner amplification, and multiplexing."

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