By Ben Butkus
Molecular diagnostic developer Micronics said this week that it has received a $2.6 million grant from the US Department of Defense to develop diagnostic tests for blood-borne pathogens on the company's PanNAT system for nucleic acid amplification-based point-of-care testing.
The Applied Research and Technology Development Award is the single largest amount of non-dilutive funding received by Micronics to date and will help the company add to the menu of tests under development for PanNAT, Micronics' president and CEO Karen Hedine said this week.
The company is also developing tests for enterohemorrhagic E. coli, various respiratory infections, and mother-to-child transmission of HIV, with the E. coli test likely first to market in early 2012, Hedine said.
The three-year, $2.6 million grant, administered through the US Army Medical Research and Materiel Command's Polytrauma and Blast Injury project, is intended to support development of molecular tests that can directly detect hepatitis B and C and HIV from fresh blood samples in order to screen out infectious blood donated for transfusion on the battlefield, Micronics said.
The device would need to have a higher degree of sensitivity than existing equipment and provide instant results, while being durable and fully functional in field testing to withstand wartime conditions, Micronics said.
The company, based in Redmond, Wash., believes that it has such a device in PanNAT, which is a portable, lightweight, sample-to-answer platform designed for field applications and decentralized laboratories. The platform is still in "beta-stage, pre-clinical" development, Hedine said.
"It weighs about eight pounds," Hedine said. "It's got a battery in it, so that gives it a little extra heft. It's designed for multi-environmental use … anywhere in the world where you want to do near-patient testing. And it's fully integrated – all the heating components, software, Wi-Fi capability, and data communications. It can transmit or store the data."
In addition, the reagents for each nucleic acid test are contained on a disposable cartridge. "All the user does is put the sample in the cartridge, put the cartridge in the reader, press go, and wait for the answer," Hedine said.
In terms of competing platforms, many companies and academic labs have compact sample-to-answer nucleic acid testing platforms on the market or in development. Of these, perhaps most comparable are Cepheid's GeneXpert system, which has an extensive test menu and uses disposable cartridges; or a number of lightweight, rugged, portable systems offered by Idaho Technologies.
Hedine said that Micronics will be targeting a slightly different market segment than competitors such as these.
"Those are larger versions," Hedine said. "I relate it to computers, sort of the mainframe to the PC to the laptop to the Blackberry. And I think we're that next generation compared to an Idaho Tech or a Cepheid."
Hedine also said that the PanNAT system is expected to have a very competitive price point, due primarily to having the "lowest cost of goods" of any competing platform, though she didn't provide an expected price for PanNAT.
"This is designed for CLIA waiver, so the goal is to really start reaching out to multiple markets that haven't really been previously addressed by either the cost or complexity of existing systems on the market," she said. "Those are all good systems, but that's just not their market, it's the reference laboratory. Our market is also the reference laboratory, but also pushing into rural hospitals, physician office laboratories, public health clinics, and community labs, which really can't afford the infrastructure of those more expensive pieces of equipment."
Part of the reason Micronics can achieve a low cost of goods is because the company has developed PanNAT, its software and sample prep components, and many primers and probes for its tests in house.
"Our goal is always to lessen the burden of the cost of goods," Hedine said. "When you have to take licenses from others, obviously that burdens your cost. We always try to use probes and primers either in the public domain or that we can design and develop internally."
However, Hedine added that "you can't always get around all the chemistries; you've got to have some, and why reinvent the wheel? So we do use commercial chemistries."
For instance, Micronics, like many companies in the nucleic acid testing space, has taken a non-exclusive license to molecular beacons hybridization probe technology from PHRI Properties, the tech-transfer arm of the University of Medicine and Dentistry of New Jersey.
In addition, Micronics has licensed the right to make, use, and sell products using Biosearch's Black Hole Quencher, CAL Fluor, and Quasar dye technologies. Micronics is combining both of these technologies with its in-house IP to develop tests for PanNAT.
In order to develop HBV, HCV, and HIV tests under the DoD grant, Micronics is working with Wei Mei Ching, a senior scientist at the Naval Medical Research Command; and John Scott, a professor in the Hepatitis and Liver Clinic at the University of Washington.
"Those are the sample guys," Hedine said. "They bring to us access to anonymous clinical samples as we get to the later stages of the award. We want to get working with real clinical samples as soon as possible."
In the meantime, Micronics' closest PanNAT assay to commercialization, hopefully sometime in early 2012, Hedine said, is for E. coli 0157:H7, the Shiga toxin-producing strain of E. coli most commonly associated with food contamination outbreaks. Last year, the US Centers for Disease Control issued a report with recommendations for for diagnosing Shiga toxin-producing strains of the bacteria after several instances of contaminated food products causing disease outbreak in the US.
"We really felt this was an opportunity we could respond to," Hedine said. "That test is further along and will hopefully be the first one out the door. That's our own assay."
Micronics is also working on nucleic acid tests for respiratory infections, in collaboration with Seattle Children's Hospital; and on other enteric pathogens. Each of these tests would require different sample prep capabilities than the HBV, HCV, and HIV tests, which are designed to work with raw blood.
"For this particular grant, it's for blood-borne pathogens," Hedine said. "But we have been working on nasopharyngeal samples and fecal samples. Whether it's blood, saliva, nasopharyngeal – it's really meant to be a sample-independent platform."