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Exiqon Licenses LNA Tech to BD for Use in PCR-Based Infectious Disease Dxs

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By Ben Butkus

Exiqon said this week that it has non-exclusively licensed its locked nucleic acid technology to Becton Dickinson for use in infectious disease diagnostics.

The licensing agreement marks the first time that a company other than Exiqon will use the LNA technology to develop diagnostic products, the company said.

In addition, the deal is part of a concerted effort by Exiqon over the last several months to partner with other companies to explore commercial applications of LNAs, around which the company has an extensive patent portfolio, CEO and President Lars Kongsbak told PCR Insider.

Under the terms of the agreement, BD will market a number of defined LNA-enhanced products for use on the BD Max, its fully automated instrument platform for performing PCR-based molecular diagnostic tests.

Exiqon will receive upfront and milestone payments, as well as royalties on global sales of products covered under the pact. Financial terms of the agreement were not disclosed.

It is unclear what type of diagnostic products BD will pursue, or how the LNA technology will enhance such products. BD did not respond to a request for comment in time for the publication of this article.

However, Kongsbak told PCR Insider that BD "obtained guidance" from Exiqon and conducted due diligence in regards to the LNA technology, and that his impression was that BD desired to incorporate LNAs into its PCR-based diagnostics for the "very specific detection capabilities" they provide.

Kongsbak said that LNAs are "RNA derivatives" that contain a ring structure in their backbone, locking the molecules in a specific configuration. As such, the LNA is constrained in an ideal binding conformation, and when incorporated into a DNA oligonucleotide, LNA makes the pairing with a complementary nucleotide strand more rapid and increases the stability of the resulting duplex.

In PCR applications, this feature allows shorter probes and primers that are "very specific, with no mismatches, and stronger and much more specific binding," Kongsbak said.

BD's diagnostics division currently markets one assay for the BD Max: a test for Group B Streptococcus, for which the company won 510(k) clearance from the US Food and Drug Administration late last month (PCR Insider, 6/3/10).

BD is also embroiled in a lawsuit with Gen-Probe, which has claimed in two separate lawsuits that sales of the BD Max — known as the HandyLab Jaguar prior to BD's $275 million acquisition of HandyLab in November 2008 — infringe upon several of Gen-Probe's patents related to its Tigris molecular diagnostics blood-screening system (PCR Insider, 3/25/10).

From Exiqon's perspective, the licensing agreement with BD is part of a broader strategy to capitalize on the LNA technology in market segments that the Danish firm doesn't plan to tackle itself.

Kongsbak said that Exiqon has a portfolio of 114 issued patents and more than 100 patent applications, not all of which specifically cover the LNA technology but all are "associated with LNA in one way or another, since that is our core technology."

Exiqon is developing its own diagnostic and prognostic products based on a combination of the LNA technology and microRNAs as biological markers. However, it is primarily pursuing the cancer diagnostics market, especially colon cancer recurrence. Kongsbak said the company is seeking a commercial partner to help it bring these products to market.

In order to gain a foothold in that market and further prove its technology, Exiqon in October launched its miRcury LNA microRNA PCR kits for quantitative real-time PCR analysis of microRNAs. The company claims that the use of two LNA-enhanced PCR primers results in a high degree of sensitivity and specificity, enabling accurate quantitation of very low microRNA levels. The kit also employs a universal RT step that greatly reduces the amount of sample necessary to as little as 80 to 100 µL, Kongsbak said.

BD also becomes the first company to take a license to Exiqon's LNA technology since Applied Biosystems, now Life Technologies, licensed the LNAs in 2008 for use in its siRNA research products.

Roche also has a license to the LNAs for use as part of its Universal Probe Library to develop and manufacture its qPCR assays. Roche and Exiqon originally signed that agreement in 2005, and amended it in 2008 to extend Roche's rights to sell and distribute ProbeLibrary products.

Kongsbak said that all of Exiqon's LNA licensing agreements are non-exclusive.

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