LONDON—Smiths Detection, whose diagnostics unit develops ruggedized instruments designed for easy operation by specialists in veterinary and clinical procedures, has signed a collaboration and license agreement with Novartis Diagnostics under which Novartis is granted exclusive rights to market Smiths Detection's Bio-Seeq instrument and the associated LATE PCR DNA analysis technology in the area of infectious disease diagnostics.
Under the agreement, Smiths Detection will leverage its expertise in instrument development and point-of-care diagnostic devices to further enhance the Bio-Seeq platform and sample preparation consumables and to develop a range of diagnostic tests. Novartis Diagnostics will be responsible for clinical trials, regulatory affairs, sales and marketing. Financial terms of the agreement were not disclosed, but payments will be linked to product development and commercial milestones.
According to Smiths Detection, the Bio-Seeq platform enables rapid, flexible and highly precise detection of bacterial and viral pathogens and is designed for users with little or no experience of biological testing. The tests use LATE PCR, a variation on conventional PCR that was originally developed by Brandeis University for which Smiths Detection holds an exclusive license. A LATE PCR reaction produces a large excess of single stranded DNA that is analyzed at the end point of the reaction. The technique allows highly multiplexed assays to be developed.
The Bio-Seeq instrument is a simple-to-use, sample-in/answer-out desktop instrument capable of running five LATE PCR tests simultaneously. The planned enhancements include increasing the number of simultaneous tests to 20 with the addition of slave units. A disposable sample preparation unit, which is used across a wide range of tests, and a reagent pack, which is particular to the test being run, round out the system.
"We are evaluating multiple advances to both the technology and the platform," says Daniel Parera, Novartis' head of development. "In addition, the platform will be tailored to address the needs of a hospital or laboratory, rather than a field-based setting. Although both require very fast time-to-results, clinical diagnostic user interfaces, reports and workflow will be optimized based on detailed human factor studies and clinical needs."
Peter Maag, president of Novartis Diagnostics, notes that "Smiths Detection offers a very attractive technology and platform, which we chose to be the basis for our infectious disease portfolio because we felt it could diagnose potentially deadly infections faster and more specifically than other platforms. In addition, the companies have complementary capabilities necessary to bring quality solutions to market—Smiths will develop technology and platform, and Novartis Diagnostics will be responsible for clinical, regulatory and commercial activities."
Finally, he adds, Smiths Detection and Novartis share a passion for preventing the spread of infectious disease and improving patient outcomes.
"Leveraging emerging technologies through collaborations such as this will be critical as we build on our already strong presence in transfusion medicine to advance preventive screening," he adds.
"We think the technology has a range of potential diagnostic applications in the area of infectious diseases," Parera states, while demurring from any specific dollar estimates. "Our aim is to address a significant unmet need for adequate and accurate early treatment by developing tests to guide physician decision making and improve outcomes. Applications will be patient-focused, and consistent with trends in patient demographics, treatment algorithms, and the reimbursement landscape."
The first tests are already in early-stage development and are expected to move through clinical trials in the next few years. Both companies have already scaled up teams and infrastructures to help speed the development process.
Bill Mawer, president of Smiths Detection Diagnostics, adds that his company is delighted that such a major health company as Novartis has chosen to invest in the Bio-Seeq platform and LATE PCR technology.
"Our close collaboration holds out great promise both for patients' well-being and healthcare savings," he adds.
Smiths Detection provides advanced security solutions in civil and military markets worldwide, developing and manufacturing government-regulated technology products that identify explosives, chemical and biological agents, weapons and contraband. It is part of the Smiths Group, a global leader in applying advanced technologies for markets in threat and contraband detection, energy, medical devices, communications and engineered components. The Smiths Group employs around 22,000 people in more than 50 countries.
