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Lynntech Wins Phase II SBIR Grant for POC Dengue MDx Using Convective RT-PCR

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NEW YORK (GenomeWeb) – Technology firm Lynntech was awarded a Phase II Small Business Innovation Research grant late last month from the National Institute of General Medical Sciences to further develop a one-step, point-of-care RT-PCR system and multiplex assay for dengue virus.

The funding totals $1.3M over two years, and is the next step after successful completion of a Phase I project that was funded in 2013.

The dengue assay will combine Lynntech's portable genome amplification module with a gold-nanoparticle-based lateral flow system to provide point-of-care detection and identification of dengue virus, John Mueller, chief technologist in life sciences and a senior research scientist at the firm told GenomeWeb in an email.

Approximately 50 million people become infected with dengue each year from bites of Aedes mosquitoes. While the virus is endemic to the tropics, a number of outbreaks have cropped up recently in Hawaii and the Southeastern US, and an outbreak in 2007 in Puerto Rico led to diagnosis of more than 10,000 cases.

Lynntech's dengue test could be useful in places where medical resources are limited, Mueller noted, adding that development of the reverse-transcriptase platform opens the door for detection of other pathogens with RNA-based genomes, like Zika, Ebola, and norovirus.              

The system uses convective PCR, a method that relies on density changes of annealing and denaturing stages of amplification. In essence, two ends of a small cylinder are held at two different temperatures, and the fluids move by convection through the necessary temperature zones for amplification, Mueller explained. The technique requires less power than other PCR-based methods, making it ideal for portable, point-of-care diagnostics, he added.

The convection method has been described previously by Victor Ugaz and was the PCR method of choice for a recent "lab-on-a-drone" project. Ugaz is a longtime collaborator with College Station, Texas- based Lynntech, and is working with the firm on the current project.

In Phase I of the project the firm demonstrated the amplification method could be used for RT-PCR of the dengue virus. "We were able to readily distinguish the four dengue serotypes in our convective RT-PCR assay, despite the fact that their genomes share 60 to 70 percent homology," Mueller noted.

Although PCR using the technique has been described previously, there are not yet any publications illustrating RT-PCR with convective amplification.

The dengue test also uses direct detection, which eliminates the need for an independent sample prep step and leads to a faster, simpler, less expensive assay, Mueller said. 

The firm is now conducting discussions with contract manufacturers and not-for-profit service organizations for validation, manufacturing, and commercialization of its diagnostic, he said.

It is collaborating with Silver Lake Research Corporation of Azusa, California to design and fabricate the lateral flow strips. "Silver Lake has years of experience in the development of lateral flow detection methods and has collaborated with Lynntech on multiple projects that have focused on biomarker and metabolite detection," Mueller said.

The firm is also working with Los Angeles-based ALine — a design, engineering, and contract manufacturer specializing in microfluidics for the life science and medical diagnostics markets — to develop a prototype and to manufacture Lynntech's convective RT-PCR cartridge.

And to facilitate the path to US Food and Drug Administration regulatory approval, the firm plans to work with a West Bloomfield, Michigan-based firm called Regulatory Affairs Associates, a company "with over 35 years of experience in developing and implementing clinical and regulatory products," Mueller said.

Lynntech is also interested in collaborating with other industrial partners, "especially as we approach the path toward manufacturing and commercialization," he said.

The firm also has several other on-going projects in the field of diagnostics, namely to detect pathogens responsible for food-borne illnesses, biological threat agents, as well as clinically relevant pathogens such as Staphylococcus aureus and multi-drug resistant organisms. These projects are funded by agencies including the Department of Defense, the US Department of Agriculture, and the Centers for Disease Control and Prevention, Mueller said.

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