When a new technology enters the market, there is often a period when critics decry its future. It happened, for example, when Kodak dismissed digital cameras. The same could be said about molecular diagnostic (MDx) testing.
"An irreversible movement is happening," states GenePOC CEO Patrice Allibert. "Previously, no one thought MDx could ever be used at point of care (POC), but our breakthrough with revogene has launched a revolution in MDx testing."
This robust, mobile instrument has shifted MDx testing from large centralised laboratories and hospitals to smaller ones. Soon, Allibert believes, this technology will bring MDx testing to pharmacies and physicians' offices, and even into patients' homes.
Powerful yet compact - being roughly the size of a laptop - revogene is easy to use, self-contained and provides connectivity in the healthcare environment without any additional computers.
The instrument holds up to eight single-use microfluidic cartridges or PIEs, allowing independent testing of multiple samples per run. It uses centripetal force technology, which drives the liquid sample flow by rotating, eliminating the need for valves and multiple pumps that would increase cost. In fact, according to Allibert, the machine offers performance similar to the best polymerase chain reaction (PCR) machine on the market.
The plug-and-run technology has an intuitive user interface, much like a smartphone, allowing a person to be trained in its use in roughly five minutes.
With the cost of global healthcare rising, populations ageing and epidemic episodes increasing, modified methods of performing diagnostics are essential, making this breakthrough vital.
Centralised laboratory testing is effective for routine testing but doesn't work for infectious diseases, which require quick diagnosis.
"Every hour lost in obtaining a result increases morbidity sand mortality," Allibert says. "Without results, clinicians launch empiric treatments, which can lead to bacterial resistance."
Current MDx technologies deliver results in an hour, but it can take up to 18 hours to transport samples from patients to labs. "We have brought the lab to the patient," Allibert says. "And revogene is the only solution on the market for decentralised testing."
The 'one-hour objective' has guided much of what GenePOC does, he says. "This timeframe can directly affect the patient's treatment or determine whether isolation is required."
This POC molecular platform can detect Group B Streptococcus in pregnant women and can be used at the time of delivery. If the result is positive, an intrapartum antibiotic prophylaxis is administrated to the mother. It can also test for Clostridium difficile, with a positive result leading to quick isolation. The third possibility is the detection of Strep Group A, C and G, allowing treatment to be implemented immediately if necessary.
Delayed test results and enforced treatments are disabling the fight against antimicrobial resistance (AMR), an issue that has long been a focus at GenePOC. Company founder Dr Michel G Bergeron launched the first MRSA, VRE and Clostridium difficile molecular tests in the early 2000s.
Allibert, an expert in MDx, has forged strong relationships with key opinion leaders in AMR to stay on top of new knowledge. "We agree with Professor Patrice Nordmann's warning that AMR is a bomb that will explode," he says. "The question is when."
Testing AMR requires multiplexing capacity and adaptability as new resistances will ultimately emerge, and building new tests each time this occurs is time-consuming and costly. GenePOC's disposable and flexible diagnostics can adapt to future changes in design without requiring complete redevelopment.
"Our goal is to use revogene, not for all microbiology testing, but for those cases that can provide clinicians with key information," Allibert says. "We will bring out assays to combat STDs and resistance to them, such as Neisseria gonorrhoea and Mycoplasma genitalium. Never forget, we always want to save lives."
The company's commitment to patient safety is earning recognition in the industry. This year, Frost and Sullivan awarded GenePOC the Disruptive Innovator Award at the 'Spotlight on Companies to Action' session. The revogene instrument also won Red Dot Design's 2017 Best of the Best award.
"We just saw a need in the market and our team delivered what was required," Allibert says. "Our instrument and first assays received the CE mark and FDA clearance."
Never resting on past achievements, GenePOC wants to create products to be used in developing countries, while it continues to fight AMR. The firm is not making cameras, but it is certain of one thing: by 2019, MDx testing will be a reality at POC facilities.