NEW YORK (GenomeWeb) – Aiming to develop a cost-effective microRNA-detection tool for pancreatic cancer detection based on a novel electrochemical biosensor platform, startup Vajra Instruments is preparing to kick off a study to validate the technology in human blood samples and lay the groundwork for future commercialization.
Vajra, a spin out of the University of Nebraska-Lincoln, was established around a technology called scanning electrometer for electrical double-layer, or SEED, which can measure multiple enzyme reactions on a monolith electrode based on the immunospecific binding with a mixture of respective analytes.
According to Vajra Founder and UNL researcher Ravi Saraf, SEED can quantitatively map local redox reactions by scanning a laser on an array of enzyme monolayer spots immobilized on the monolith electrode. It then measures the change in local charge state of the electrical double layer of the electrode caused by the redox reaction.
While Saraf sees potential for the technology in a variety of applications, his first goal is to develop it for the early detection of pancreatic cancer by measuring the levels of miRNAs associated with the disease in blood samples.
Currently, pancreatic cancer ranks as one of the most deadly cancers, largely because it is rarely detected before it has become metastatic. Biomarkers for the disease exist, Saraf told GenomeWeb, but these are only effective once the cancer has progressed into its later stages.
A number of groups have been investigating whether blood-borne miRNAs can serve as early-stage biomarkers for the cancer, many generating promising data. But most of these efforts, Saraf noted, rely on RT-PCR approaches to amplify and detect target miRNAs, which is expensive due to the cost of fluorescent labels and other required reagents, and can be difficult to multiplex.
With SEED, "we are striving for a technology that has a high enough sensitivity that we don't need PCR at all," Saraf said. "All we do is take blood, extract the RNA, and then do the measurement."
In preliminary studies, Vajra has shown that SEED is capable of detecting target miRNAs with .1 picomolar sensitivity and no signal from non-specific binding using plasma or serum samples of .5 mL.
These results, however, were obtained using synthetic miRNAs, Saraf noted. As such, the company is now aiming to prove the technology with natural human-derived miRNAs.
With a recently awarded a nine-month, $293,322 Phase I SBIR grant from the National Cancer Institute, Vajra is aiming to analyze de-identified samples from about 100 individuals including pancreatic cancer patients, healthy individuals, and pancreatitis patients.
The goal of this study, according to the grant's abstract, is to detect around 10,000 copies of five different cancer-associated miRNAs with a sensitivity of .01 pM using 1 mL of serum or plasma. The results will then be compared with RT-PCR.
At the same time, Vajra intends to continue efforts to further miniaturize the SEED instrument, which Saraf said is currently around the size of a microscope, in order to bring its cost down to a commercially attractive level.
Should the Phase I study be successful, he said that Vajra would then try to secure a Phase II SBIR grant to run a larger study that would generate the data needed to commercialize the SEED technology for early pancreatic cancer diagnosis and, potentially, the differentiation of the disease from related conditions including pancreatitis.
Ultimately, he added, Vajra aims to develop SEED for various applications including the measurement of proteins, DNA, and food and water toxins.
But at the moment, the pancreatic cancer program is "the big one," Saraf said.