About 15 years ago Chris Toumazou imagined that if the electronics industry could scale down electronic circuits so that they were smaller, faster, and cheaper to produce – paving the way for consumer-based products like mobile phones and tablets – it might be possible to apply microchips to the health care industry.
Inspired by that idea, Toumazou, a professor at Imperial College London, invented a way of detecting protons released during DNA synthesis to enable DNA sequence detection using a standard silicon-chip based transistor. This optics-free, label-free method shifted DNA sequencing from specialized, expensive genome centers into the mainstream of local labs and primary care clinics. Now, the company that Toumazou founded as a spin-out from Imperial College, DNA Electronics Ltd. (DNAe) is in the late stages of developing a point-of-need solution for rapid DNA analysis – and the platform has attracted the attention of the U.S. government.
The Biomedical Advanced Research and Development Authority (BARDA) awarded the London-based company a contract worth up to $51.9 million to develop its DNA sequencing platform for the rapid diagnosis of antimicrobial resistant infections and influenza. DNAe said the contract will support the development and validation of its Genalysis platform, as well as a series of applications for FDA clearance.
As the father of a boy who lost his kidneys at a young age due to a genetic predisposition, Toumazou told Medical Device Daily that early detection is something he has long been passionate about.
"You wonder, if we detected it early enough, maybe we couldn't have prevented it, but we could have managed it better," he said.
According to the company, the platform will combine the ability to sequence the DNA of the infectious organism, in a sealed microchip-based system, direct from a clinical specimen, with analysis that enables actionable identification of the disease agent within a few hours. The first product will be a rapid blood-to-result diagnostic system aimed at bloodstream infections that lead to sepsis.
DNAe said the new system is already in late stage development and testing and is expected to be ready to launch in 2018.
The collaboration with BARDA demonstrates the suitability of DNAe's next-generation sequencing platform to address a range of clinical needs, Toumazou said, as demonstrated by the application in antimicrobial resistance and influenza testing, where there is a very high unmet need."
When a doctor prescribes a patient a drug, such as an antibiotic, for instance, making sure that person can metabolize that drug quickly becomes critical, Toumazou said. Blood tests can take up to three days to answer those questions, and by that time the antimicrobial-resistant bug has mutated so many times that it's too late, he said.
The Genalysis platform is designed to return results within a couple of hours to guide treatment decisions before it's too late.
The company is also leveraging technology from Nanomr Inc., an Albuquerque, N.M.-based company DNAe acquired in January 2015 for that developed a system for rapid isolation of rare cells in the bloodstream. The acquired technology is designed to target multiple rare cell types such as those contained in bacteria and fungi from bloodstream infections at levels of 1 cell/mL or lower in less than 30 minutes, making it the ideal sample preparation technology for DNAe's rapid point-of-need diagnostic tests, the company said.
By combining the two systems, Toumazou said, "we go straight from sample to result almost on a desktop" simply by taking a blood sample and putting it into something that looks like a mother board of a computer with a microchip, he said.
BARDA had a hand in moving along the development of the automated sample preparation system as well, with a $21.5 million contract awarded to Nanomr in 2014.
Sam Reed, president of DNAe's Washington-based office, who is leading the sequencing program, said the platform can be operated by users who are not specially-trained in sequencing, enabling it to be used in a wide range of near-to-patient environments where sequencing has not been possible before. "Unlike existing sequencing devices, the platform operates 'push button' directly from raw clinical specimens such as blood or swabs, delivering a clinically-relevant report for the physician," Reed said.