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InDevr Prepares POC AmpliPhox System for Q4 Debut, RUO FluChip to Launch in 2011

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By Justin Petrone

InDevr, a Boulder, Colo.-based life-sciences firm, will later this year launch a point-of-care colorimetric-detection system for use with low-density microarrays. Additionally, the firm is planning a menu of pathogen-detection arrays, the first of which will become available next year, according to a company official.

Erica Dawson, lead scientist for molecular diagnostics and a business development associate at the firm, told BioArray News last week that InDevr is currently seeking more beta sites to test its AmpliPhox colorimetric detection system. The portable AmpliPhox platform has been in beta testing since March, and privately held InDevr aims to make the system commercially available by year end.

The firm said recently that it aims to soon place 50 free trial kits including instruments and reagents with scientists working with low-density microarrays or assays that utilize biotinylated targets immobilized on transparent substrates.

Dawson said the system is anticipated to launch in the fourth quarter, and that InDevr is seeking beta sites that have their own lower-density chips in development. "Because the detection technology is general, it can be utilized for DNA-based and protein-based arrays, and is a good choice for researchers looking for an inexpensive option to other available technologies," she said.

InDevr aims to "reach interested researchers who would like to try out a new and innovative detection technology that has no capital equipment costs and comparable sensitivity to fluorescence detection," Dawson added.

At the same time, InDevr is also preparing its first assay for use with AmpliPhox. Called FluChip, the low-density array is based on multiplexed reverse transcription and PCR amplification. Dawson said that FluChip is currently undergoing preclinical testing "for an anticipated launch as a research use only product in 2011."

InDevr announced in May that it was working with scientists in the influenza division of the US Centers for Disease Control and Prevention in Atlanta to develop a separate low-density array for screening influenza A viruses for genetic reassortment (BAN 5/11/2010).

In addition to these chips, InDevr is developing a panel for respiratory pathogens called the ResVChip, which can simultaneously detect the presence or absence of influenza A, influenza B, parainfluenza viruses I and III, human metapneumovirus, and adenovirus. It also includes an internal control. Scientists at the US Department of Agriculture have developed an array that runs on the AmpliPhox system and can detect the presence of toxin-producing Escherichia coli.

Founded by University of Colorado, Boulder, scientists in 2003, InDevr last year launched its ViroCyt Virus Counter, a flow cytometer designed for virus quantification that yields total, infectious, and non-infectious virus concentration measurements. According to Dawson, InDevr is ready to support the launch of AmpliPhox based on its experience with the Virus Counter, which it markets via capital equipment sales and online reagent sales.

"We are fully prepared to expand our manufacturing and customer-service capabilities to support the new AmpliPhox product line," she said, though she noted that both the reader and reagents for the lower-priced AmpliPhox will be available for online purchase.

Dawson said that the AmpliPhox system was designed specifically for "resources-limited" labs that required next-generation technology for pathogen-detection purposes. The system has been developed via a four-year, $1.2 million grant from the National Institute of Allergy and Infectious Diseases, as well as a bioscience discovery-evaluation grant from the state of Colorado.

InDevr's AmpliPhox colorimetric detection method is based on light-initiated signal amplification through polymerization. Biotinylated targets are first captured, and subsequently labeled in a 10-minute procedure with a reagent called AmpliTag. Next, a reagent called AmpliPhy is poured onto the array surface and the slide is inserted into the instrument. The photo-induced reaction occurs in about two minutes, and forms solid polymer spots only in locations where biotinylated target was captured and labeled. The transparent spots are then stained to improve visualization, and the image is collected.

According to InDevr, the field-portable AmpliPhox Reader both initiates the signal amplification process and collects a digital image of the result, and InDevr's AmpliView software is then used for automatic image interpretation. While the company is developing its own assays for use with the system, Dawson said that AmpliPhox is capable of supporting user-designed experiments.

"Any user-designed microarrays that fit within a 1 cm2 area on a transparent substrate can be used," Dawson said. "Most of our work to date in-house has focused on nucleic acid arrays, but protein-based arrays can also be utilized."

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Marketing the system as an "inexpensive alternative to traditional fluorescence-based microarray detection methodologies," Dawson said that the AmpliPhox Reader will cost about $4,500 upon launch, a price she estimated is "ten-fold less expensive than typical fluorescence-based microarray scanners."

Fluorescence-based microarray scanner prices vary, but typically range between $100,000 and $150,000. Upon its release in 2008, for instance, Agilent Technologies' DNA Microarray Scanner cost $150,000 while Tecan's Power Scanner had an original price quote of $139,000 (BAN 6/10/2008).

Gentel Biosciences, a Madison, Wis.-based company, has launched a colorimetric detection-based proteomic platform that supports protein array analysis. That system, which has a US list price of $8,990, is based on Silverquant, a method developed by Eppendorf in which gold particle-enhanced silver crystal deposition is used to detect and quantify microarrays (BAN 3/9/2010).

Dawson said that InDevr's colorimetric detection technology will "make low-density microarray applications available to many individuals unable to afford the high cost of a microarray scanner." The system is also being targeted to space-limited labs. She noted that AmpliPhox is an 8-inch by 16-inch system that requires an associated miniature laptop computer.

Like the AmpliPhox system, InDevr's arrays are also being targeted towards scientists that cannot afford current generation microarray-detection technologies. For example, Dawson said that the FluChip assay was designed to "enable the surveillance of influenza viruses in resources-limited areas." That might give it an opportunity to carve out a niche in a market that includes influenza-monitoring arrays sold by firms like TessArae, ArrayIt, and Veredus Laboratories.

Each company's flu-themed microarray product is different. For example, Potomac Falls, Va.-based TessArae's Affymetrix-based TessArray RPM-Flu test detects and differentially identifies more than 35 classes or types of viral and bacterial respiratory pathogens. The US Food and Drug Administration granted the test emergency use authorization last year (BAN 12/22/2009).

Singapore-based Veredus Labs, meantime, recently achieved a CE-IVD mark for its PCR and microarray-based VereFlu test and accompanying VereID Biosystem technology platform, allowing it to sell the assay for clinical use in Europe (BAN 3/23/2010).

According to Dawson, the FluChip currently uses around 10 unique targets to detect all influenza A viruses and discriminate between viruses of human and non-human origin based on a unique microarray signature. In addition, the FluChip assay incorporates an internal control and the ability to detect influenza B specimens as well, she said.

"Clearly, the FluChip does not provide the level of detail that something like sequencing provides, but we see it as a powerful tool in those situations where rapid screening of specimens that may warrant further testing by a higher information content method is desired," Dawson added.

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