London-based testing firm Smiths Detection said last week that it will make the LATE PCR DNA-amplification and -analysis technique widely available for human point-of-care diagnostic applications through a single license program that combines technologies developed at Brandeis University and the University of Medicine and Dentistry of New Jersey.
Through its business unit Smiths Detection Diagnostics, the company plans to license what it calls the LATE PCR toolkit to companies as an alternative to real-time PCR — a license for which is often too expensive for smaller companies to afford, it said.
Smiths has worked with researchers at Brandeis over the last several years to develop veterinary and biodefense applications for the technology, and has continued sponsoring research at the school to also tackle the human point-of-care diagnostic market, John Czajka, business development director at Smiths Detection Diagnostics, told BTW this week.
LATE, or Linear-After-the-Exponential, PCR, was developed in the laboratory of Brandeis University researcher Larry Wangh. Smiths, whose primary experience has been in the chemical, explosives, and X-ray detection market, stumbled across the Brandeis technology in 2004 when it was seeking a PCR tech that would enable endpoint, rather than real-time, detection, Czajka said.
Since that time, Smiths secured an exclusive worldwide license to the Brandeis technology, with the right to sublicense it, and began sponsoring research in the Wangh laboratory. Czajka said that the company currently funds all of the lab's studies.
"It's an interesting relationship, since we fund the Wangh laboratory 100 percent, which has alleviated any milestones that may come up," Czajka said. "Typically when we've done funding like this, the IP has become Smith's property, although sometimes there is joint ownership.
"I think it's a unique arrangement, and from a business standpoint, it allowed Smiths to interact very closely with the Wangh laboratory and have a very focused R&D arm within Brandeis University," he added.
Czajka declined to disclose financial details of its relationship with Wangh's lab or Brandeis. According to a Brandeis University life-sciences newsletter, the company, which is a subsidiary of global technology company Smiths Group, will provide the lab with approximately $1.38 million in funding this year.
The lab had also previously investigated several probe technologies to complement the LATE PCR technique, and determined that the optimal technology would be the so-called "molecular beacons" developed at UMDNJ.
Molecular beacons are hybridization probes that enable direct detection of specific nucleic acids in living cells and diagnostic assays, and have been the subject of more than 40 non-exclusive licenses for various applications in several industry sectors (see BTW, 6/3/2009).
A little over a year ago, the company also negotiated a non-exclusive license to that technology from PHRI Properties, the tech-transfer company of UMDNJ, to use the probes in veterinary and biodefense applications, also with rights to sublicense.
In October 2008, Smiths created Smiths Detection Diagnostics to develop veterinary and POC human diagnostics using the combined technology. The company has since expanded its license with PHRI to include different aspects of POC diagnostics, and is currently developing products, including instruments and assays, towards those applications, Czajka said.
As reported in November by BTW sister publication GenomeWeb Daily News, the first POC application being developed by the company was a multiplex assay for methicillin-resistant Staphylococcus aureus, which Smiths was seeking to evaluate by partnering with hospitals in the UK and US.
Now the company is betting it can sub-license what it's calling the LATE PCR toolkit to small biotech companies, particularly in the clinical diagnostics field.
The toolkit will provide licensees "with a package of IP to develop and run assays, and that would include the LATE PCR technology, the molecular beacon probes, and later, an enzyme supplier and custom assay development, and a web-based community where users can interact with other users and the Brandeis and UMDNJ researchers," and seek advice on the selection of polymerases, fluors, controls, and other assay components.
"We envision making this technology widely available to all markets and affordable to all users, since the cost of licensing real-time PCR for commercial applications can be quite high," Czajka said. "We are trying to provide a comprehensive package without having to go and negotiate multiple agreements with various companies. We're kind of following PHRI's lead on getting their technology licensed at an affordable rate."
Smiths claims that the technology also has technical advantages over real-time PCR methods, which amplify both strands of DNA. In contrast, LATE PCR produces large quantities of single-stranded DNA from the selected target, the company said, which means that in the absence of the competing complementary strand, probes can be used over a wide temperature range.
This feature allows high levels of multiplexing and the creation of assays that can identify individual strains of an organism, or analyze genes that confer antibiotic resistance, the company said.
Smiths' hope is that licensees will develop custom assays based on the sub-licensed technology and bring them to market.
"We're currently shopping it around," Czajka said. "We're discussing sublicenses with other companies right now." The company has also developed a portable PCR system with an automated sample preparation component, "and we're also developing those systems as open platforms," he said. "If someone wanted to run a special assay under a license, they could then sell it to be run on the Smiths portable system."