There have been many technologies that at one time “disrupted” laboratory testing. Radioimmunoassays allowed for minute quantities of an analyte to be measured, and next generation sequencing made DNA sequencing accessible to more patients. More recently, cell-free fetal DNA is changing the way aneuploidy screening takes place.
Today, AACC’s Disruptive Technology Award session offers a peek into the next chapter of disruption by recognizing innovative testing solutions that can potentially alter the landscape of laboratory testing and ultimately improve patient care. Three competition finalists—Two Pore Guys, GNA Biosolutions, and Ativa Medical—will present data on their respective technologies during a special session from 4:30 – 6:00 pm. A panel of expert judges will evaluate and score the three teams based on feasibility and performance. In addition to the judges, attendees also will have the opportunity to vote for the technology that they believe will be the most impactful.
Two Pore Guys, based in Santa Cruz, CA, has developed a solid-state nanopore test strip and detector system that monitors single molecule passing through a nanopore. The current iteration of the device is intended to take prepped samples that are inserted into the test strip; however, the goal is to make the entire device—prep and detection—fully integrated. This device has the potential to detect nearly any molecule of interest, depending on how the molecule is “tagged,” according to the company’s chief science officer Trevor Morin, PhD. He believes the technology has numerous potential uses across a wide range of markers—from agriculture and animal testing to environmental testing, and of course, clinical care.
The company is most excited about the potential applications to laboratory medicine, particularly cancer, Morin said. The portability of the instrument coupled with an expected turnaround time of 10-15 minutes could allow point-of-care testing for infectious diseases like Zika and influenza. Currently there are more than 20 different assays in development, and several have been tested with clinical samples.
Another finalist, Munich, Germany-based GNA Biosolutions, will showcase an ultrafast PCR system called pulse controlled amplification (PCA) for molecular diagnostics. Recognizing that PCR was the time-limiting factor in bringing molecular diagnostics outside the core laboratory, the company designed its system to heat samples for PCR instantaneously, then cool them immediately with a surrounding reservoir solution, allowing for results within 10 minutes.
“Our goal is to make it as easy as possible to be close to the patient,” said co-founder Lars Ullerich, PhD. The goal is for a technology that becomes part of the clinical workflow for infectious disease and antimicrobial testing. Ullerich also sees potential for the technology to be used by others and become a part of the laboratory workflow, with the intent of standardizing POC and central laboratory results. Currently, GNA Biosolutions is developing assays for MRSA and TB with industry partners and funded research.
The third finalist, Ativa Medical, also has an eye toward POC testing. “People underestimate the nuances of blood testing,” said David Deetz, one of the co-founders of the St. Paul, MN-based firm. “You need to understand the size of the problem.”
Ativa Medical plans to bring comprehensive medical testing to the world of POC testing through “broad decentralization,” Deetz said, utilizing microfluidics to perform the same assays as automated analysers but on a miniature, low-cost scale. The current sample volume is 40 mcl, but they anticipate a smaller volume after finishing optimization. Deetz said he envisions the device could be used throughout the developed and emerging markets in settings ranging from outpatient clinics to regions that that do not have access to hospital laboratories.
Each of the three finalists offers a unique take on the future of diagnostics. In addition to presentations at today’s special award session, attendees also can explore each finalist’s technology at their booths in the AACC Clinical Lab Expo.