Anagnostics will soon begin offering arrays for its HybCell cylindrical array platform that will enable researchers to analyze KRAS mutations, and hopes to make a commercial assay available by the end of this year.
KRAS mutations are found at a high rate in leukemias and colon, pancreatic, and lung cancers. Anagnostic's assay, which is based on the Austrian biotech's compact sequencing method, relies on an internally developed, three-stage primer extension method to detect mutations of codon 12 and codon 13 in the KRAS gene.
The assay is also capable of detecting mutated DNA in formalin-fixed, paraffin-embedded samples, according to the firm.
Markus Jaquemar, managing director of sales, marketing, and business development at Anagnostics, told BioArray News last week that the company has been developing its compact sequencing application for several years, and is now poised to support mutation analyses of several genes associated with cancer.
In addition to expanding its KRAS assay to support analysis of codon 61 mutations in KRAS, he said the firm plans next year to add clinically relevant mutations of the EGRF and BRAF genes to the oncology-themed panel. Other tests are also planned, though he declined to elaborate.
"The first test for KRAS is the tip of the iceberg," said Jaquemar. "KRAS has found wide acceptance as a proven assay for solid tumors" and Anagnostics' first assay is "intended for oncology departments and commercial labs analyzing cancer tissues" as well as for pathologists, he said.
Once available, Anagnostics' panel will compete directly with Qiagen's PCR-based TheraScreen KRAS kit, which is designed to enable physicians to identify colorectal cancer patients who may not benefit from anti-EGFR therapies, such as cetuximab, sold by Merck as Erbitux.
Qiagen's kit detects seven KRAS mutations in codons 12 and 13. The kit is also sold by Roche under its own label in some markets.
Going head to head against Qiagen and Roche is likely to be a challenge for privately held Anagnostics, which is based in St. Valentin, near Linz, Austria's third-largest city. According to Jaquemar, while the four-year-old company lacks its competitors' global reach, he said the firm's microarray-based assay is faster and more sensitive than PCR.
"Scientists are using [TheraScreen], and there are other tests out there today; however, they either take too long or do not provide [as high] sensitivity or [are not] as easy to use" as Anagnostics' assay, he said.
Using the company's Hybcell arrays, scientists can "get down to less than 1 percent detection of mutation versus wild-type DNA," Jaquemar said. "Others are around between 5 and 10 percentage detection sensitivity," he added. The total processing time for the assay is three hours from sample preparation to result.
Jaquemar said the company is launching the new platform at a time when its target market is more apt to adopt new technologies. "The mutation detection market is transferring from research to being a routine tool," he said. "This is a place where we fit perfectly, as doctors are more likely to use a new technology than convert to a new platform."
In terms of developing new panels, Jaquemar said that Anagnostics' platform is also an asset. "One of the benefits of our technology is that once we have established proof of concept for one assay, establishing a new panel is very rapid," he said. "That is a three- to six-month process."
DX, SX, and 3D
Anagnostics' platform differs from others on the market. While traditional arrays are printed on slides, Anagnostic's Hybcell arrays are composed of detector molecules — DNA or proteins — which are immobilized on the surface of an inner cylinder.
This cylinder is enclosed within a cylindrical container. Users can fill this external cylinder with sample, and up to 96 Hybcell arrays can be processed at a time in the company's Hyborg system, which integrates a thermal cycler, a hybridization station, and a scanner.
The company sells two Hyborg systems. Hyborg DX is intended for routine analysis and processes prefabricated Hybcells only with "locked-down application protocols," Jaquemar said. Hyborg SX, meantime, is aimed at the research market to enable scientists to write, edit, and modify protocols and interact with Anagnostics' staff to design their own Hybcell applications. Both systems have been available commercially since the second quarter (BAN 2/9/2010).
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Anagnostics' current market is in Europe, and more specifically Austria, Germany, and Switzerland. Earlier this year, the company tapped Darmstadt, Germany-based Peak-Service to offer field support for its systems (BAN 3/2/2010).
Peak-Service provides support throughout Europe and the US, according to its website. Jaquemar said that Anagnostics is focused on expanding into Belgium, the Netherlands, and Luxembourg, and said the UK, Denmark, Norway, and Sweden are also "important" markets for the firm.
While the company has focused this year on placing its Hyborg DX and SX systems with first adopters, it has also developed a series of themed arrays for routine diagnostics on the Hyborg DX.
This summer it launched two panels to screen samples for the presence of drugs of abuse in urine. The first, Hybcell DoA Urine Basic, screens for six major drugs: amphetamine, cocaine, methadone, opiates, THC, and buprenorphine.. The second, Hybcell DoA Urine Screening, includes an extended panel for 19 drugs and drug classes: amphetamine, cocaine, methadone, opiates, THC, buprenorphine, MDMA, benzodiazepines, barbiturates, oxycodone, phencyclidine, tricyclic antidepressants, methamphetamine, ethylglucuronide, fentanyl, tramadol, zolpidem, and zopiclone.
Jaquemar said that both tests are in final development to screen saliva samples as well. He said the firm has at least one reference customer that is using the Hybcell DoA assays in a routine diagnostics environment. A CE-IVD marking for the DoA Basic Kit is expected in the first quarter of 2011, he said.
In addition to drugs-of-abuse screening, Anagnostics has arrays in development designed to screen for the presence of sexually transmitted and infectious diseases. Jaquemar said that the Hybcell STD assay will be available to early-access customers by the end of the year.
As Anagnostics pushes ahead with its themed diagnostic panels, the company is also engineering a new generation of its Hybcell array platform. It has been working with the Institute for Microsystems Technology, or IMTEK, at the University of Freiburg in Germany, in the area of surface chemistry.
Specifically, Anagnostics has been working with Jürgen Rühe, chair for chemistry and physics of interfaces at IMTEK, to establish three-dimensional structures on the surface of the firm's Hybcell arrays. Based on polymers, the 3D spots could provide microstructures and a considerably larger surface for on-spot reactions, the firm claims.
"This surface provides enhanced sensitivity and will be commercialized, once fully developed," said Jaquemar. "In order to enhance sensitivity, you don’t only have two-dimensional bonding, but a 3D layer that binds the molecules you want to attract."