SAN DIEGO—In late 2020, Progenity Inc. gave an oral presentation and showed a poster at the American College of Gastroenterology (ACG) virtual annual meeting regarding the Progenity Ingestible Laboratory Diagnostics (PIL Dx) capsule in small intestinal bacterial overgrowth (SIBO).
PIL Dx is an ingestible capsule with a built-in assay and a fluorescent spectrophotometer. The capsule is designed to achieve targeted localization, collect and analyze intestinal fluid samples, and transmit data in real time without a need to recover the capsule, offering doctors a promising alternative for diagnosing SIBO—and eventually, other difficult-to-diagnose gastrointestinal (GI) disorders.
The oral presentation was given by renowned gastroenterologist Dr. Satish Rao, who showed results of a multisite study of 66 subjects in which a benchtop version of the Progenity SIBO assay showed 94-percent agreement with the current standard of endoscopic aspiration and total bacterial count.
In conjunction, the poster presentation focused on physician research and expert analysis of the need for a novel SIBO diagnostic. Also, it showed a clear physician preference for the PIL Dx product concept over existing testing options.
“I am very pleased with the results of our collaborative research. Our data highlight the potential for innovative technologies, such as those being developed by Progenity, to advance the field and provide less invasive, yet accurate tools to diagnose SIBO,” said Rao, who is a professor of medicine in the Medical College of Georgia at Augusta University. “The studies showcased at ACG indicate promising progress towards ingestible, autonomous assays that could one day become a gold standard in GI diagnostics, where today, none exist.”
SIBO is an abnormal overgrowth of bacteria in the small bowel. With signs and symptoms that overlap with other gastrointestinal diseases, it can be difficult to diagnose, leading to over 100 million patient visits in the United States annually. Current diagnostic methods are invasive, costly, and inaccurate, which often leads to the use of antibiotics without a clear diagnosis.
While current methods—including endoscopy and bacterial count—may take up to seven days, the ingestible pill would provide doctors with results within 24 hours. The system has three components: a capsule, a wearable receiver, and analysis software. The capsule is a single-use device swallowed by the patient. The capsule determines its location in the digestive tract, collects a sample, and performs an onboard assay to measure metabolites, proteins, nucleic acid biomarkers, and bacterial load. The results are wirelessly communicated from the wearable receiver to the software for review and evaluation using Progenity’s analytics and bioinformatics technologies.
This platform has broad application potential, including characterization of disease through detailed assessment of the small intestinal epithelial interphase, which could lead to identification of diagnostic biomarkers and therapeutic targets and pathways. Additionally, the platform may enable development of early pharmacodynamic evidence for drug efficacy and prediction of therapeutic response, which, if successful, should increase the efficiency of drug development.
Currently, the Smart Capsule Bacterial Detection System, or SCBDS capsule, has undergone a series of validation and verification tests of the various subsystems and evaluations of the localization algorithm. The autonomous localization technology is based on a proprietary LED light and photodetector sensor array that detects reflected light in the GI tract, and uses a proprietary algorithm to determine anatomical locations of interest—for example, the pyloric and ileocecal transition. In three clinical studies evaluating the localization technology, localization of the capsule was confirmed either by CT scan or scintigraphy. In addition, these studies proved the performance of the communication subsystem as data was transmitted to a wearable receiver.
The primary objective of the multi-site clinical study presented at the ACG conference was to examine the in-vitro accuracy of the SCBDS bacterial concentration assay against the standard clinical measurement of total bacterial count from duodenal aspirate obtained via endoscopy.
The study enrolled 54 patients suspected of SIBO across two sites and 12 patients undergoing upper endoscopy for all indications at one site for a total of 66 patients across the three sites. The primary analysis was the agreement between the SCBDS assay and the standard total bacterial count at identifying bacterial concentrations greater than 105 colony forming units per milliliter of intestinal fluid, which is the generally accepted definition of SIBO. Progenity reported that across the 66 patients, there was 94-percent agreement between the SCBDS assay and total bacterial count.
Progenity’s ingestible onboard assays are currently being developed to aid in the diagnosis of numerous GI disorders. This platform technology has the potential to become the gold standard for noninvasive evaluation of the intestines, enabling a more personalized approach to patient management. Progenity is developing a broad test menu for this diagnostic platform, including tests for irritable bowel syndrome, nonalcoholic steatohepatitis, colon cancer, and inflammatory bowel disease.
The company’s ingestible diagnostic platform is designed to collect and analyze mucosal fluid while in transit through the intestines, transmitting analysis data to a wearable device, with no ingestible device recovery needed and no sample to send to the lab. Onboard assays will perform pre-specified analysis including measurement of microbes, proteins, nucleic acids, and pharmaceuticals.
“The enthusiastic reception of these data by the GI community points to the clear unmet need for new tools to better diagnose and differentiate SIBO from other gastrointestinal disorders. Our PIL Dx technology, a digital laboratory in a capsule, promises to provide a simple, more rapid, and relatively non-invasive solution, with accuracy comparable to current reference standards,” stated Dr. Harry Stylli, CEO, chairman and co-founder of Progenity. “These studies represent the achievement of a critical milestone as we continue to advance our PIL Dx platform towards preclinical and clinical studies in 2021, and ultimately to commercialization. Our goal is to offer true precision medicine by combining novel diagnostics and therapeutic solutions.”