August 24, 2017 | At the Next Generation Dx Summit* last week, over 100 exhibitors and sponsors shared new technologies, research updates, and their visions for the future of diagnostics. Diagnostics World published a roundup of new products during the event, but we also toured the expo floor, talking with speakers and tech experts, gathering more perspective for what’s need next in diagnostics.
Trans-Hit Bio and MT Group, two biospecimen access CROs, announced the launch of the Lung Cancer (NSCLC) Consortium Study with a whitepaper. “The benefits of molecular biomarker researcher are invaluable in the detection, diagnosis, and treatment of disease, and scientists need collections of more complex biospecimens (specific mutations and associated clinical data),” the whitepaper authors wrote. “Unfortunately, the low prevalence of some mutations as well as the need for biospecimen from later stage patients (for cDNA or CTC) are today’s biggest bottleneck to [liquid biopsies and drug development.]”
The consortium will include expert biobanks and investigator sites to provide biospeciments from late stage lung cancer patients to help facilitate research and validate liquid biopsy assays. The consortium’s goal is to collect high quality biospecimens from 4,000 to 5,000 lung cancer patients at diagnosis, during therapy, and at relapse, complete with biomarker status and detailed clinical history. The goal is for at least 70% of the biospecimens to represent late stage disease, representing “relatively rare biospecimens”, the two groups said in a white paper announcing the consortium. Pascal Puchois, CEO at Trans-Hit and Tom Moss, Vice President at MT Group are leading the charge and have enlisted a scientific advisory board as well. They hope the consortium will allow pharma and diagnostics companies to more quickly validate assay, fill clinical trials, and conduct research.
In a luncheon presentation, Bruce Patterson, CEO and cofounder of IncellDx, explored the differences between life sciences and diagnostics. There’s a challenging bring technology from life sciences applications to diagnostics, he said. There’s a huge difference between the two. IncellDx offers single-cell diagnostics on a technology platform that enables simultaneous cell classification and single cell analysis of proteomic and genomic biomarkers. The company is working to make sure all its technologies are fit for diagnostic use, not just pulled from the life sciences, Patterson said.
Russell Garlick, CSO of SeraCare Life Sciences, chipped away at another standby of life sciences research: reference materials. The Genome in a Bottle dataset, for instance, can’t be used in some cases, Garlick said. There’s a scarcity of rare variants and a limited supply of naturally occurring reference materials, or patient samples, with which to characterize circulating tumor DNA assays. What diagnostics developers need, Garlick said, is “a truth set, a stake in the ground.” SeraCare’s family of Seraseq reference materials offers that “truth” set for solid tumors and ctDNA, he said. The company calls the Seraseq materials “the most patient-like ctDNA reference materials.”
Quanterix has twice won the Head Health Challenge sponsored by GE and the National Football League. Kevin Hrusovsky, CEO at Quanterix, gave the NFL much credit for its work unwriting research on better diagnosing concussion in sports. Quanterix’s Simoa technology can quickly identify proteins in blood that indicate brain injury, Hrusovsky said. It’s amplification-free detection; there’s no need for PCR. But the applications are much broader than just on the football field. Hrusovsky said the company is working on other neurology applications—identifying Alzheimer’s Disease and dementia much earlier. There are also oncology and cardiology applications.
Quanterix debuted its new, desktop Simoa platform at the event—the SR-Plex Ultra-Sensitive Biomarker Detection System—making it even easier for the technology to be used in a variety of settings. While the NFL has committed significant resources to curbing concussions in its players, Hrusovsky is even more worried about younger players. The NFL has neurologists watching every play, he told Diagnostics World. But in college and high school, the players don’t have that kind of oversight. Hrusovsky believes that high school football players die from second-impact syndrome. A player takes a hard hit, but can pass verbal and physical tests for concussion on the sidelines. He’s sent back into the game and a second hit—sometimes a seemingly light impact—causes sudden death. Hrusovsky hopes that better testing will help coaches and doctors know when it’s safe for a player to return to the field.
In an Almac presentation, Katarina Wikstrom, director of US operations for Almac Diagnostics, urged attendees to work toward co development of clinical trials and companion diagnostics. We need to bridge those two developmental pathways, Wikstrom said. In the future, Wikstrom said that a universal companion diagnostic could be possible with a DNA-based test. The RNA said is realistically much further away, she said, doubting that a universal expression test is in the near future.
On the exhibit hall floor, Redbud Labs was demonstrating advances in microfluidics. Mixing is often a limiting step in diagnostic assays, explained Richard Spero, CEO. No matter how fast your chemistry is, your assay will be slow if your reactants aren’t properly mixed. MXR is the Redbud Labs solution, a layer for diagnostic cartridges that use a tiny motor to move miniscule magnetic rods—tiny stir bars for your test cartridge. It’s an elegant solution—simple and efficient. Spero said the MXR chip can make microarrays ten times faster.
*Next Generation Dx Summit; August 15-18, 2017; Washington D.C. The event was sponsored by Cambridge Healthtech Institute, the parent company of Diagnostics World News