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Italy's DiaSorin Enters MDx Space with Launch of Isothermal Amplification-Based Testing System

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Italian in vitro diagnostics firm DiaSorin has launched in Europe an isothermal amplification-based genetic analysis system and two associated assays for BK virus and varicella-zoster virus, marking the company's first foray into the molecular diagnostics space.

The platform, called the Liaison Iam analyzer, is based on technology called Q-LAMP — DiaSorin's own quantitative, real-time version of loop-mediated isothermal amplification, or LAMP — which offers many of the desirable traits of quantitative real-time PCR but with significantly reduced cost, according to the company.

In addition, DiaSorin is looking to pair its system, which currently requires manual sample preparation, with automated nucleic acid extraction technology and instrumentation it acquired earlier this year along with the molecular diagnostics assets of Norwegian company NorDiag, in the hopes of building a complete sample-to-answer workflow for decentralized molecular testing, Paul Eros, global vice president of marketing for DiaSorin, told PCR Insider this week.

Eros said that DiaSorin, which has been around for more than 40 years specializing primarily in immunodiagnostics, began sniffing around the molecular diagnostics space about five years ago. In 2007, the company acquired an option to license the LAMP technology from its owner, Japan's Eiken Chemical, for clinical diagnostic applications.

"That's when [DiaSorin] started to look at it very seriously as an option for its molecular diagnostics platform," Eros said. "Previous to that, they'd been looking at PCR, but there were clearly some opportunities they thought were beneficial by going down the LAMP route … not the least of which is simplicity of instrumentation. With LAMP and Q-LAMP, it's an isothermal reaction, which doesn't require the highly sophisticated heating, cooling, and rapid ramping associated with PCR instrumentation, and the cost can be kept down."

To wit, Eros said that DiaSorin can offer the Liaison Iam analyzer in the range of $5,000, whereas a typical price for a real-time PCR-based system is around $30,000 – although this figure can of course vary wildly depending on certain system features and capabilities.

The Liaison Iam is a small, benchtop unit that connects to a separate control unit via a USB interface. Each instrument can take up to eight samples and can be connected to as many as six other instruments through the control unit for higher volume testing needs.

The company did not disclose a specific amount of time necessary to run an assay on the platform, but Eros noted that it is "significantly" faster than real-time PCR because the Q-LAMP method obviates the need for thermal cycling.

One of the most distinguishing capabilities of the system, and differences between the Q-LAMP and LAMP methods, is that assays can be multiplexed with up to six recognition events per reaction in a single tube.

"It's why we're not talking about LAMP, but Q-LAMP … because we are able to run the assays in real time," Eros said. "Q-LAMP is pushing LAMP technology a lot closer to [real-time] PCR than it has ever been. Not only are we multiplexing, but you can differentiate between the different LAMP products, and see those in a real-time plot using our software, and can identify wild type from mutant targets, or ID two different targets in the same reaction."

The "Q" in Q-LAMP, he noted, stands for both "quantitative and quenching, because we use quenching of the fluorophore for real-time amplification."

Eros said that sample preparation for Liaison Iam assays is currently done separately. Depending on the sample type, sample prep can add significant time and cost to a molecular diagnostics workflow; hence, the speed comparison between DiaSorin's platform and some other systems — especially those with integrated sample prep — may not be completely apt.

However, DiaSorin hopes to address this issue by using technologies that it brought in house in May when it acquired the MDx assets of Oslo's NorDiag for €7.6 million (about $9.96 million at the time). These technologies include reagent kits for extracting nucleic acids from a wide variety of sample types, including blood, plasma, urine, swabs, stool, and sputum; and a pair of instruments for automating nucleic acid extraction — the higher throughput Bullet and lower-throughput Arrow platforms.

The lower throughput Arrow instrument is cartridge-based and can extract nucleic acid from up to 12 samples simultaneously or one at a time, Eros said, making it "ideal for a decentralized setting." Both of NorDiag's products are currently commercially available in Europe and the US.

"At the same time, we will be validating the assays for use with some more common extraction technologies that are available in customer labs, so, for example, [technologies] from Qiagen and [BioMérieux's] NucliSens EasyMag," Eros said.

The first two assays for the Liaison Iam are Iam BXV, for diagnosing and quantifying clinically relevant subtypes of BK virus in human plasma and urine; and Iam VZV, for detecting clinically relevant subtypes of VZV in human cerebrospinal fluid and vesicle swabs.

DiaSorin plans to launch additional assays for toxoplasmosis, cytomegalovirus, and parvo B19 later this year; followed in 2013 by assays for Epstein-Barr virus, herpes simplex virus I and II, and a range of assays to aid in the diagnosis of leukemia.

All told, the company is hoping to be able to offer "close to 30 specific assays" for its instrument by the end of 2014, both in infectious disease and blood cancer, Eros said.

"It's not an instrument where we will launch one or two assays," he said. "We're really driving content in the decentralized diagnostics area. By the end of 2014, we will have a significant portfolio of products."

The Liaison Iam and current associated assays are available only in those countries recognizing the CE mark. Eros said that DiaSorin has begun the process of seeking US Food and Drug Administration approval for its platform, but declined to specify which assays the company might initially seek approval for.

Concurrent with the product launch, which was in late October, DiaSorin began a program to work with "key opinion leaders" in multiple countries in order to "give them the opportunity to evaluate the technology and be amongst the first to publish using the technology," Eros said.

He also noted that DiaSorin and its early collaborators have presented a few scientific posters on the Q-LAMP method and the Liaison Iam, but that peer-reviewed publications vetting the technology are still forthcoming.

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