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Denmark's Fluimedix Raises $1.1M to Develop Warfarin Test for PCR-Based Platform

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By Ben Butkus

This article has been updated from a version posted Sept. 20 to include comments and additional information from a company official.

Danish diagnostics firm Fluimedix said this week that it has closed an investment round worth DKK 6 million ($1.1 million), bringing the amount raised by the company to about $3 million since it was founded in 2003.

Fluimedix will use the new investment to support the development of a diagnostic test for warfarin metabolism on NanoCycler, its benchtop, PCR-based diagnostic platform.

Founding investor SEED Capital Denmark led the latest investment round, which also included existing shareholders, whom the company did not identify.

Fluimedix was founded in 2003 to develop NanoCycler based on technology invented by independent engineer and current CEO Tomas Ussing. The company is based at the Danish Institute of Technology in Taastrup, where since 2005 it has collaborated with DIT's Institute for Surface Analysis and Microtechnology.

In addition, Fluimedix collaborates with Thomas Werge, head of research at the Mental Health Centre at Denmark's St. Hans Hospital, which is involved in pharmacogenetics research.

NanoCycler is a tabletop device designed to accept a disposable polymer cartridge in which a number of biochemical reactions are performed on a human saliva sample, the company said.

The platform uses a medium-powered infrared laser diode, which is directed at microfluidic channels and reservoirs to enable microfluidic flow control, thermocycling, cell lysis, mixing, and fluorescence excitation, according to the company.

More specifically, sample preparation is performed inside the disposable cartridge on isolated buccal cells, Ussing said this week in an e-mail to PCR Insider. Then, a small diode laser lyses the cells using "timed and thus controlled" laser pulses, while another inexpensive laser diode is used as a heating source to perform thermal cycling, Ussing said.

The platform cycles 1-µl-volume increments that "cool instantly when the laser is turned off," Ussing added. "By measuring the temperature we are able to heat [and] cool at extreme rates" of approximately 35 cycles every 10 minutes, he said.

NanoCycler runs "industry-standard endpoint PCR assays so that the company can "stay clear of third-party IP," Ussing said. Fluimedix also said that NanoCycler is fully automated and capable of providing a result in less than 15 minutes.

In a statement, Ussing said that NanoCycler offers a number of benefits as a diagnostic platform, such as comprising "low-cost, well-established components" and using plastic disposables that enable "extremely competitive molecular diagnostic testing … closer to the patient."

Ussing also said that "genetic testing with the NanoCycler may have a positive impact on patient diagnosis and treatment, and may deliver substantial cost savings in the long term."

Although Fluimedix's initial focus will be on the warfarin test, NanoCycler is designed to identify the presence or lack of a number of SNPs from patient samples, the company said. Thus far it has demonstrated proof of concept for the NanoCycler using the CYP2C19*2 SNP as a model marker.

"There is a present market for warfarin dosing," Ussing said. "We have until now been working on CYP SNPs since we are working with [Denmark's St. Hans Hospital] and they have been frontrunners on developing pharmacogenetic guidelines in connection with psychiatric drug administration."

However, Ussing added that the company is "basically building the platform so we will be able to take any human SNP onto it. If you can design a PCR assay for a given mutation, we can incorporate it."

Ussing also said that the company is "working on a 7- to 10-month schedule" to commercialize the warfarin test.

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