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Applied BioCode, Maxwell Sensors Pushing Dx Technology to 1,024 Plex

By Tony Fong

NEW YORK (GenomeWeb News) – Armed with a $2.8 million grant from the National Institutes of Health, molecular diagnostics and testing firm Maxwell Sensors and its sister firm Applied BioCode hope to build up Maxwell's bead-based array technology from its current 32-plex capability to 1,024 plex in the next six months.

Earlier this week, the two companies based in Sante Fe Springs, Calif., announced they had received a $2.8 million, three-year grant from the Recovery Act Limited Competition: National Institutes of Health, to further build out their Barcoded Magnetic Beads technology. In an interview, Winston Ho, CEO of both Applied BioCode and Maxwell Sensors, told GenomeWeb Daily News that the funding will be used to increase the plex rate on its technology 32-fold, move it to commercialization, and develop applications for the technology.

Applied BioCode was formed about two years ago to commercialize and market technologies developed by Maxwell Sensors. Though Ho is the CEO of both companies, he said that the two operate financially independently.

The magnetic beads and its reader, called the BioCode-1000 Analyzer, which is imaging based, are currently commercially available in a 32-plex format. At the American Association for Clinical Chemistry's annual conference later this month in Anaheim, Calif., Applied BioCode will launch a 128-plex version of the beads and of the BMB Analyzer, Ho said, adding that the plan is to have a prototype for a 1,024-plex bead and system, which will be flow-based, in about four to six months.

While the technology has a number of different applications, initial attention will be given to infectious diseases, with cancer and companion diagnostics development the target of future work, he added.

The technology is based on photolithographic technology used in semiconductors. The beads are made of polymers and barcoded. On the surface of the beads are functional groups to which proteins or DNA are attached for use as probes.

After different barcoded beads are mixed into "a cocktail" in a microwell, fluorescence is used to detect the probe's target and quantify them. Because each probe has a specific barcode, a researcher can easily analyze multiple targets in one sample, Ho said.

"Eventually the bead [settles] on the bottom of the microwell and we just do direct imaging," Ho said. "There is no microfluidics. It is very, very simple and reliable."

Using the 96-well BioCode Analyzer, multiple analyte tests can be done in each well in 40 seconds, the company said in a statement announcing the NIH grant.

The BMB system competes with other established bead-based assay systems such as Illumina's BeadXpress system, which recently received FDA clearance, and Luminex's xMAP technology. According to Ho, however, the BMB technology offers advantages, such as scalability, over other systems. Luminex's technology, for example, is based on dyes and the fluorescence intensity, and "fluorescence-based microbeads typically have scale-up difficulty," he said.

"Its barcode classification is based on the fluorescence intensity ratios generated from two or three dyes that are emulsified in a bead," Ho added. "Because the dye fluorescence spectrum is very broad, the number of allowed bandwidth is therefore limited. Furthermore, measuring each fluorescence intensity separately and accurately is also quite challenging, especially [because] some of the broad spectra may overlap."

According to Applied BioCode's website, the BMB barcode patterns "give a high-contrast transmitted signal and no fluorescence background, allowing the barcode to be identified easily and accurately, with near 100 percent decoding accuracy."

Because fluorescence is detected at a steady state, the company said, "the variation of the fluorescence signal is minimal, which is very important for quantitative assays, such as [for] protein analysis."

Its NIH grant is from the National Institute of Allergy and Infectious Diseases. In the grant abstract, Applied BioCode and Maxwell Sensors said that the BMB system allows for the identification of a "panel of pathogens that are impossible or difficult to culture in the clinical microbiology laboratory setting," and will provide physicians with a timely and cost-effect diagnostic method for the "early [and] effective management of infected patients."

It added that because the BMB system allows for multiple tests to be performed in one well, rather than for only one test as with conventional platforms, its technology "certainly can reduce the expense of diagnostics by all-in-one tests."

The grant, made available as part of the American Recovery and Reinvestment Act of 2009, is for work that is further along the commercialization pipeline than research typically supported by NIH grants, Ho said. In the grant abstract, the companies said that the funding will go toward developing the BMB technology for rapid tests for methicillin-resistant Staphylococcus aureus and respiratory panels.

Maxwell Sensors has "successfully combined" its BMB and target-enriched multiplex polymerase chain reaction technologies for simple, rapid, multiplex tests, including a 14-plex respiratory viral pathogen H1N1 panel, an 18-plex MRSA panel, and a 12-plex healthcare acquired infection panel, it said in its grant abstract.

As Maxwell Sensors and Applied BioCode expand the capabilities of the BMB technology, the two firms are in talks with other firms about potentially partnering to commercialize products resulting from its continuing work, Ho said, though he declined to identify them.

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