Nascent digital PCR company QuantaLife has been awarded $820,000 from the National Institutes of Health for the first year of a five-year project aimed at developing microdroplet PCR-based point-of-care tests to detect methicillin-resistant Staphylococcus aureus, according to grant information published this month by NIH.
The grant will also support a collaboration with the University of Mississippi Medical Center to help further develop and clinically evaluate the tests, according to its abstract.
QuantaLife, based in Pleasanton, Calif., was founded in 2008 to commercialize technology from Lawrence Livermore National Laboratory in nearby Livermore, Calif. The company has been operating in stealth mode over the last two years as it develops a digital PCR platform that uses emulsion-generated microdroplets to partition individual PCR reaction volumes.
In a July interview with PCR Insider, Michael Lucero, QuantaLife's vice president of marketing, said that QuantaLife's technology can create tens of thousands of monosized droplets each with a volume of about one nanoliter.
The company also is developing a readout instrument that is akin to a "droplet cytometer" and can read whether each of the droplets is creating an amplification signal at the rate of around 10,000 droplets in less than a minute.
Lucero also said at the time that QuantaLife would be using the technology to tackle applications such as copy number variation detection, copy number alteration, point mutation detection in cancer, and even gene expression studies – all applications being targeted by established competitors such as Fluidigm and companies with earlier-stage digital PCR platforms, such as Life Technologies and RainDance Technologies (PCR Insider, 7/15/10).
However, the new NIH grant, administered by the National Institute of Biomedical Imaging and Bioengineering, appears to also signal QuantaLife's foray into the diagnostics market.
QuantaLife officials could not be reached for comment for this article, but the grant abstract states that the company aims to develop "accurate tests with rapid turn-around times" of less than 15 minutes that could "increase the efficacy of active detection and isolation and active surveillance testing for MRSA prevention and control programs and molecular diagnosis across all healthcare settings."
The company said that it believes that "droplet PCR will provide accurate test results with reduced analysis time, complexity, and cost thereby making nucleic acid amplification tests viable near point of care;" and that it plans to develop two in vitro POC nucleic acid amplification tests capable of making "billions of copies of DNA in tiny droplets that accurately fingerprints the bacteria."
In addition, the grant would provide support for a partnership between technology developers at QuantaLife and healthcare professionals at the University of Mississippi Medical Center.
"QuantaLife scientists and engineers have decades of experience developing and fielding diagnostics for biological pathogens, and will be responsible for designing and building the prototype droplet PCR instrumentation and accompanying assays," the abstract states.
UMMC, meantime, "has the requisite clinical expertise, specifically in the area of healthcare-acquired infections, to guide test design and requirements and critically evaluate droplet PCR performance and potential impact in real- world clinical settings," according to the abstract. "These partnerships could accelerate the translation of droplet PCR technology from the laboratory into an instrument for near-point-of-care testing thereby impacting healthcare sooner."
Ben Hindson, chief scientific officer at QuantaLife, is named as principal investigator on the grant.
The NIBIB grant comes on the heels of the company raising $7.5 million of a planned $15 million equity financing round, according to a document filed in June with the US Securities and Exchange Commission.
QuantaLife also previously raised an undisclosed amount in a Series A financing led by Paladin Capital Group, according to a statement issued by the company earlier this year. According to another SEC filing from 2009, the company raised at least approximately $8 million that year as part of a planned $13 million financing round.