NEW YORK (GenomeWeb) – Started as a company to monitor a person’s smoking habit, UK firm GFC Diagnostics is developing a medical device to detect antibiotic-resistance biomarkers in bacteria that it said can provide results significantly quicker than current technologies being used.
The firm has entered its device for the Longitude Prize, and this week it, along with Spinout Linear Diagnostics, is showcasing its technology at the Superbugs: The Fight of Our Lives exhibit in London. GFC previously received one of three Longitude Prize Discovery awards to help fund development for its technology last year.
Spun out of the University of Birmingham in the UK in 2007, GFC Diagnostics began as a point-of-care detection firm for assessing and monitoring a person’s smoking habit. Technical director Graham Cope invented the Safetube device to run urine and saliva-based tests, and his team eventually expanded its testing repertoire to include Microscreen, a test that uses a swab of saliva to perform DNA hybridization in order to detect genetic biomarkers in methicillin-resistant Staphylococcus aureus.
Running on the Safetube device, Microscreen uses two DNA probes to coat the tube with a complex chemical mixture, which captures the bacterial products in a suspension. The oligonucleotide probes hybridize across the target gene, with one probe labeled with horseradish peroxidase to amplify the gene signal.
The test uses a type of tetramethylbenzidine color agent to induce a color change in the solution. If the Microscreen test detects the mecA biomarker associated with MRSA, the solution produces a dark blue color. If not, the solution turns a light, pale blue. From sample preparation to color indication, the overall process for each sample requires about 30 minutes, according to GFC.
GFC CEO Bruce Savage said that the Microscreen test stands out from its competition because "unlike PCR assays, our technology doesn't need extraction and purification," and does not require pipettes or other external equipment, simplifying the workflow and reducing overhead costs. Instead, the Microscreen sample kit comes with syringes and uses the same format as the company's other point-of-care tests, but uses "different chemistry invented in house."
Working with the University of Northampton, GFC diagnostics has performed an evaluation test on cultured MRSA samples to increase the test's sensitivity, though Savage declined to comment further on the collaboration.
Setting its sights on uncultured MRSA, GFC plans to perform clinical tests at the Public Health Lab in Southampton University Hospital to help determine the test’s sensitivity and specificity. Savage believes that the firm will initiate testing by the end of November and continue into spring 2018 in order to build data.
In the meantime, GFC will use the same technology to develop nucleotide probes for other antibiotic-resistant genes, including biomarkers for Carbapenem-resistant enterobacteriaceae and extended-spectrum beta-lactamase.
While GFC's test is easy to use for technicians unfamiliar with molecular biology techniques, Savage believes that the Microscreen is not simple enough to use at home as a direct-to-consumer test. However, the test does not require additional equipment, since researchers can dispense samples and solutions using fixed volume syringes supplied in the sample kit.
Savage also noted that while companies such as Cepheid also have point-of-care antibiotic-resistance tests already on the market, they take longer to get results than the 30 minutes achieved with GFC’s technology. Savage expects to price the test competitively, but declined to disclose a figure at this time.
Later this month, GFC plans to attend Medica 2017 in Dusseldorf, Germany in order to start early discussions with European microbiology diagnostics companies that lack a range of PCR-based infectious disease diagnostic tests as potential partners.
Savage mentioned that clinical samples are a massive hurdle in diagnostics development and "are often different and more challenging to work on" than laboratory samples. He believes in the next six months GFC will discover whether the MicroScreen will truly work on real-life patient MRSA cells.
A year ago, the company filed for a patent on gene detection and whole bacteria without extraction in the UK, and are currently still waiting for approval.
In addition to GFC Diagnostics, Spinout Linear Diagnostics will also present its bacterial and antibiotic-resistance detection technology at the Superbugs exhibit in London. Its device performs a test for both bacteria and antibiotic resistance by using polarized light to measure alignment of detector molecules. When molecules attach to the target, which are either bacteria or antibiotic-resistance genes, they lose alignment and the measurement changes.
Spinout's device will be used for early diagnosis and to ensure that a patient's prescribed antibiotics are not resisted by the bacterial infection. The researchers plan to begin using the device in early 2018, where it will be used in hospitals and general practitioner surgeries to detect antimicrobial-resistant urinary tract infections, according to a statement.
The company did not respond to requests for comment.