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Startup Nawgen Looks to Develop Genome-wide microRNA Profiling Assays


NEW YORK (GenomeWeb) – With the proceeds of a recently awarded a one-year grant from the National Institutes of Health, startup Nawgen is aiming to develop a portfolio of real-time PCR assays for microRNA expression profiling covering the entire human and mouse genomes.

According to Xiaowei Wang, a researcher at Washington University in St. Louis who founded Nawgen, the assays are expected to be ready by early next year. The company is currently exploring its options for sales and marketing, including partnering with a bigger life sciences player, he added.

Nawgen's core technology stems from Wang's longstanding interest in miRNA biology, which led to the development of a novel RT-PCR method for profiling the small, non-coding RNAs that was designed to overcome the limitations of microarray analysis, such as poor specificity, and existing PCR methods, including low throughput.

"For real-time PCR assays, the most critical factor is high-quality primers," he told GenomeWeb this week. To that end, he developed a bioinformatics algorithm to guide the design of miRNA primers that enhance assay specificity, sensitivity, and homogeneity.

The primers are then used in an miRNA profiling strategy that involves performing a reverse transcription reaction using a pool of primers that anneal specifically to target miRNAs and result in a pool of mixed cDNA products from the miRNAs of interest, according to a 2009 publication.

After the reverse-transcription reaction, separate RT-PCR assays are performed to quantify the expression of individual miRNAs.

"Each PCR is performed with two primers that are uniquely associated with the miRNA of interest, one with a miRNA-specific sequence and the other from the unique tag sequence in the [reverse-transcription] primer," Wang wrote in the paper. "Thus, these primers are not likely to cross-react to primers from other miRNA assays even though multiplexed RT reactions are performed."

Wang and his colleagues have used this platform to profile the expression of cancer-related miRNAs and identify disease biomarkers in hundreds of archived tissue samples, resulting in a several publications including a 2010 paper describing an miRNA signature associated with cervical cancer prognosis.

In an effort to commercialize the technologies he developed, Wang acquired their rights from WashU. Now, with the support of the approximately $225,000 NIH grant, Nawgen has now begun work to develop assays for all human and mouse miRNAs. He added that the company is also aiming to establish an online database where researchers can review experimentally validated assays.

While the assays can be used to focus on a few hundred miRNAs in a particular sample for miRNA biomarker discovery, Wang anticipates that they will be particularly useful for validating miRNA profiling results generated from microarray and next-generation sequencing studies.

Additionally, he said the assays are expected to offer researchers a tool for profiling low-quality degraded RNA from archived clinical tissues, noting that his lab has been able to analyze miRNA expression in formalin-fixed, paraffin-embedded tumor samples more than 20 years old.

Wang said that he anticipates the assays being completed by next spring. Still, just how they will be marketed remains to be worked out.

Wang said that while the company has enough grant funding to cover its anticipated research and development expenses, it has yet to set up any sales and marketing infrastructure. He added that he has ongoing discussions with potential industry partners to make the assays available through their existing sales channels, although Nawgen hasn't ruled out commercializing the assays itself.