Clinical Laboratories and Research Organizations Are Racing to Get Low-Cost, Handheld DNA Analyzers to Market

Portable devices have potential to analyze DNA and produce results in the field in minutes to hours, eliminating the need to return to a medical laboratory to analyze samples

Pathologists continue to hear about research efforts to create small devices that can perform DNA analysis. In the past year, four research organizations, including one in the United States, one in New Zealand, and two in the U.K., have unveiled several devices that will analyze DNA in the field.

This line of research is of particular interest in developing countries where resources such as electricity for refrigeration are scarce. Some of the DNA testing devices will produce results in minutes to hours, eliminating the need to return to a clinical laboratory to analyze samples.

Mobile Medical Laboratory Designed to Fit in a Pocket

Ranging in size from little more than a pack of gum to about the size of a large brick, these devices for DNA analysis have the potential to serve as mobile medical laboratories for pathologists in the field.

In March, the open access journal GigaScience published a research article stating that the MinION, a pocket-sized DNA sequencer from Oxford Nanopore Technologies in Oxford, U.K., can distinguish among strains of bacteria and viruses in less than six hours. Researchers used the device to identify closely related bacteria and viruses, demonstrating that the MinION has the potential for use as a mobile diagnostic clinic, GigaScience reported.

Independent Assessment of Nanopore Sequencing Device

The MinION is the first nanopore sequencing device made available for independent assessment, according to The Scientist magazine. “The USB-powered sequencer contains thousands of wells, each containing nanopores—narrow protein channels that are only wide enough for a single strand of DNA. When DNA enters the channels, each base gives off a unique electronic signature that can be detected by the system, providing a readout of the DNA sequence,” The Scientist reported.

The MinION from Oxford Nanopore Technologies in Oxford, U.K., is a pocket-sized DNA sequencer that can distinguish among strains of bacteria and viruses in less than six hours. Researchers plan to use the device for environmental surveillance. (Photo copyright The Genome Analysis Centre)

Genetic Data Delivered for Immediate Analysis in the Field

Oxford Nanopore Technologies still needs to develop a way to amplify DNA to create a detectable sample, and the device may not work on complex samples that include host DNA, The Scientist added.

The device will allow researchers from The Genome Analysis Centre, a research institute in Norwich, U.K., to conduct live environmental surveillance and deliver genetic data for immediate analysis. This would reduce the need to gather samples for later examination in a clinical laboratory, according to a report in ScienceDaily.

Otago University Researchers Develop Device for Real-Time qPCR

Also in March, the Freedom4 from Ubiquitome, a startup company in New Zealand, was named a top pick at the 22nd International Molecular Medicine TriConference (Tri-Con) in San Francisco.

The size of a large brick, Freedom4 is a “first-of-a-kind handheld device for performing realtime or quantitative PCR (qPCR) in the field,” wrote Jerry Zon, Director of Business Development for TriLink BioTechnologies in a post on his blog, Zone in With Zon. Researchers from the University of Otago in New Zealand, presented a poster and demonstrated the Freedom4 at Tri-Con, Zon reported, adding that Ubiquitome priced the device at $25,000.

In August 2014, Silicon Valley startup InSilixa announced that it had developed a chip that could run highly accurate DNA tests in an hour for $20 per test on a handheld reader that would cost $250. In press reports at the time, InSilixa, of Sunnyvale, California, said that its product, the Hydra-1K, would bring molecular diagnostics to the point of care by sharply cutting the time and expense required to detect disease. Field tests that are expected to take two years were just starting, the company said in the press release.

At the time of this writing, InSilixa’s website stated that the company was “building the next generation of high-performance CMOS biochips for microarray technology, qPCR, and DNA sequencing,” and that they were “currently in stealth mode.” No other information was available.

U.K. Company’s Handheld DNA Analyzer Delivers Diagnostics in Minutes

In September 2014, QuantuMDx, a medical device maker and commercial laboratory in Newcastle, U.K., announced a prototype called Q-POC, the company’s handheld DNA analyzer. QuantuMDx said the device is capable of delivering complex diagnostics in minutes for a few dollars in any setting.

An article posted on the Re/code website reported that the Q-POC likely will cost $1,000 and the cost of cartridges to test for various diseases will range from a few dollars to as much as $100. Last year, QuantuMDx was planning to apply to the Food and Drug Administration (FDA) for an Investigational Device Exemption. In the meantime, it plans to introduce the device in developing countries later this year, the Re/code article stated.

QuantuMDx explained that to run DNA analysis using Q-POC, health workers would insert a sample—such as a drop of blood, sputum, or even tumor tissue—enter patient data, and press Go. “The device automatically carries out sample preparation, DNA extraction, amplification, and detection,” the company said, adding that it will produce a diagnostic result in less than 15 minutes.

Collectively, these research and development initiatives demonstrate the rapid pace of development of portable devices that can analyze DNA. The obvious target for these researchers is to make DNA sequencing a point-of-care tool for use in developing countries and other areas where medical care is scarce. Clearly further research is required before any of the products are ready for use in clinical settings. However, given that the design teams for each of these devices expect to deliver a viable product for clinical use in the near future, it may not take many more years before pathologists will be able to use these devices in support of patient care.

—Joseph Burns

Related Information:

New Medical Laboratory-in-a-Suitcase Detects Ebola in 15 Minutes or Less

Bacterial and Viral Identification and Differentiation by Amplicon Sequencing on the MinION Nanopore Sequencer

Pathologists Could Have DNA Sequencing Device That Connects to a Smartphone and Can Produce Immediate Results from Several Types of Medical Laboratory Samples

Portable DNA Sequencer Can ID Bacteria and Viruses

Rapid DNA Sequencing Used with Clinical Laboratory Tests to Halt MRSA Outbreak in English Hospital

Portable DNA Sequencing ‘Laboratory’

UCSF Genomics Diagnostics Team Uses Next-Gen Sequencing as a ‘Laboratory-Developed Test’ to Reveal an Elusive Pathogen’s DNA and Save a Teen’s Life

Top Picks from Tri-Con 2015

New High-Tech Mobile Medical Laboratories Deployed by the U.S. Navy and a European Consortium Use Genetic Analysis to Get Rapid Diagnosis of Ebola

Freedom4 a Top Pick from Tri-Con 2015