Nanosphere’s gene analyzer soars through first testing round

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NORTHBROOK, Ill., April 22, 2004 – The early reviews on Nanosphere, Inc.’s nanoparticle-based gene detection technology are beginning to come in. And it looks like the technology could be a hit with the lucrative clinical lab market, according to its first group of testers.

The Northbrook, Ill.-company launched its Verigene tabletop analyzer for the research market last June. The analyzer is based on core technology that involves coating gold nanoparticles with strings of nucleotides that complement a given genetic target. When the target binds to the nucleotides that are attached to the nanoparticles, the device indicates a match.

The Verigene analyzer can theoretically test for any genetic sequence, and do several tests simultaneously. For its first test (or “assay” in clinical lab parlance), Nanosphere chose two genetic markers associated with thrombosis, or the tendency to form dangerous blood clots that lead to heart attacks and strokes. Two-to-three million people develop thrombosis in the U.S. annually, and being able to identify potential thrombosis patients before clots form could help prevent more than 50,000 deaths a year.

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Testers in three sites, including the Medical College of Wisconsin in Milwaukee, Evanston (Ill.) Northwestern Hospital,  and Hartford (Conn.) Hospital, used Nanosphere’s gene analyzer to identify patients with the two genetic markers. Each of the three sites compared the Verigene device with results from a commercially available device that had already analyzed the same patient data. Wisconsin pitted it against the LightCycler from medical diagnostics giant Roche. Evanston compared it to the Invader from Third Wave Molecular Diagnostics, and Hartford used the Nanochip product by Nanogen.

In 300 patients, Verigene correctly analyzed 98 percent of the samples on the first try, and 100 percent on the second pass, said Paul Jannetto, assistant professor of pathology at the Medical College of Wisconsin and the lead author on the study. “We were quite pleased with these results, especially for a device that’s not in full manufacture yet,” said Jannetto.

The results of the trial will be presented at the next meeting of the American Association for Clinical Chemistry, to be held in Los Angeles in July.

Jannetto identified several advantages of Nanosphere’s device over those currently in use, including simplicity, multiplexing, quick turnaround, and a small footprint.

Jannetto cited simplicity because his team was able to complete genotypes for 100 patients in a day and a half with “minimal training.” His other device, the Roche LightCycler, required the user to interpret results, whereas the Nanosphere machine handled the interpretation. (He said the next generation of the LightCycler is scheduled to have built-in interpretation as well.)

The Nanosphere device’s multiplexing capabilities meant that it conducted both tests at the same time, whereas the other devices had to do them in sequence.

Jannetto said this feature would be particularly important in future pharmacogenetic studies, where clinicians need to test patients’ genetic sensitivity to certain drugs. “We might want to do 10 [genetic marker] tests at once, and this can do that.”

Jannetto also included quick turnaround as an advantage. Most gene analysis devices use a polymerase chain reaction (PCR) method of making multiple copies of the genetic material to be tested.

Jannetto estimated that this adds at least an hour to the turnaround time for any device that uses it, while Nanosphere’s does not. He also cited the Verigene analyzer’s small footprint, because it takes up about four square feet and doesn’t require any special environmental accommodations. Jannetto said Verigene’s main drawback compared with other products is the lack of available tests, a disadvantage likely to be rectified as development proceeds.

Nanosphere COO Vijaya Vasista said Nanosphere’s next step is to get FDA clearance to start manufacturing the assays. “This facility can be made to meet [good manufacturing process] standards, but we need to build it out,” she said. “We hope to be selling early next year.”

Nanosphere is getting a substantial boost from the war on terror for its work developing tests useful for emergency response teams. The Technical Services Working Group, a government agency that funds technology to fight terrorism and mitigate its effects, recently awarded the company a $2.5-million contract over 18 months.

The funding will be used to develop assays for quickly detecting an undisclosed number of bioterror agents, including botulinum toxin, the substance that makes botulism so deadly, and ricin, the highly poisonous castor-bean extract mailed to Senate Majority Leader William Frist in February.

Nanosphere already holds a multi-million-dollar contract from TSWG to develop a quick-turnaround anthrax detector. Awarded in 2002, that contract has been extended, Vasista said. Both contracts will fund the development of sample-preparation techniques, which she said are the most challenging part of bringing the Verigene device to full commercialization. The new contract is the largest of 10 TSWG contracts announced over the past six months.

Vasista added that Nanosphere would soon be raising a fourth round of venture capital. Its last round, completed in early 2003, raised a total of $15 million. The company’s backers include Lurie Investments and NextGen Partners in the U.S., and TakaraBio Inc. of Japan.

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