Progenity Presents Data from Award-Winning Abstract on Novel Ingestible Lab-in-a-Capsule at American College of Gastroenterology (ACG) 2020 Virtual Annual Meeting

Rhea-AI Summary

Progenity (Nasdaq: PROG) recently presented data on its PIL Dx technology at the ACG virtual annual meeting. This ingestible capsule aims to improve the diagnosis of Small Intestinal Bacterial Overgrowth (SIBO). The presentations highlighted a study showing a 94% agreement with standard diagnostic methods, emphasizing the technology's potential to provide accurate, non-invasive testing. As Progenity progresses toward commercialization in 2021, the GI community's positive reception indicates a significant unmet need for better diagnostic tools in gastrointestinal diseases.

Positive

• PIL Dx technology shows 94% agreement with standard SIBO diagnostic methods.
• Enthusiastic reception from the gastroenterology community highlights unmet diagnostic needs.
• Potential to advance towards commercialization in 2021.

Negative

• None.

Oral and poster presentations feature data on the use of PIL Dx to assess and diagnose SIBO

SAN DIEGO, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (Nasdaq: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products and innovation in the field of gastrointestinal precision medicine, is pleased to announce an oral presentation, which was awarded the Category Award (Small Intestine), and a poster, both related to the Progenity Ingestible Laboratory Diagnostics (PIL Dx) capsule in SIBO, which are presented at the American College of Gastroenterology (ACG) virtual annual meeting taking place October 23-28, 2020. The data in these presentations demonstrate the achievement of critical de-risking steps in Progenity’s progress toward novel approaches for the assessment, diagnosis, and future treatment of gastrointestinal diseases through ingestible capsule devices.

Small intestinal bacterial growth (SIBO) is an abnormal overgrowth of bacteria in the small bowel, with signs and symptoms that overlap with other gastrointestinal diseases leading to over 100 million patient visits in the US annually. Current diagnostic methods are invasive or inaccurate, which often leads to empiric use of antibiotics without a clear diagnosis.

PIL Dx is an ingestible capsule with a built-in assay and a fluorescent spectrophotometer designed to achieve targeted localization, collect and analyze intestinal fluid samples, and transmit data in real time, without a need to recover the capsule. As such, PIL Dx represents a promising alternative for diagnosing SIBO, and eventually, other difficult-to-diagnose GI disorders.

The oral presentation by renowned gastroenterologist Dr. Satish Rao, MD, PhD, FACG highlights results of a multi-site study of 66 subjects in which a benchtop version of the Progenity SIBO assay showed 94% agreement with the current standard of endoscopic aspiration and total bacterial count. “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 Dr. Rao. “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.”

The poster presentation showcases physician research and expert analysis of the need for a novel SIBO diagnostic and a clear physician preference for the PIL Dx product concept over existing testing options.

“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,” said Harry Stylli, PhD, 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.”

Presentation details are below:

Evaluation of Smart Capsule Bacterial Detection System (SCBDS) assay and duodenal culture in subjects suspected of SIBO and undergoing upper endoscopy: Interim analysis
Presenting Author:	Satish Rao, MD, PhD, Professor of Medicine, Medical College of Georgia at Augusta University
Abstract ID:	S1282
SIBO Diagnosis: Clinical Survey of Practice Patterns, Unmet Needs, and Perception of a Novel Ingestible Diagnostic Capsule
Presenting Author:	Baharak Moshiree, MD, MSc, Professor of Medicine, Atrium Health, University of North Carolina
Poster Number:	P1144 (S0507)

The abstracts and presentations are available to view on demand through the ACG virtual annual meeting website, as well as on the Progenity website following the meeting.

About Progenity
Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity’s vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit www.progenity.com.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and timing of our research and development efforts, including clinical trials, and the timing for regulatory approvals are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company’s actual results to differ materially from the forward-looking statements expressed or implied in this press release, including those described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Progenity’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the U.S. Securities and Exchange Commission. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:
Robert Uhl
Managing Director, Westwicke ICR
IR@progenity.com
(619) 228-5886

Media Contact:
Kate Blom-Lowery
CG Life
kblomlowery@cglife.com
(619) 743-6294

FAQ

What is Progenity's PIL Dx technology?

PIL Dx is an ingestible capsule designed for diagnosing Small Intestinal Bacterial Overgrowth (SIBO) using a built-in assay and spectrophotometer.

How effective is PIL Dx compared to standard diagnostic methods?

A study reported that PIL Dx shows 94% agreement with traditional diagnostic methods like endoscopic aspiration.

When did Progenity present its findings on PIL Dx?

Progenity presented its findings at the American College of Gastroenterology annual meeting from October 23-28, 2020.

What is the future plan for Progenity's PIL Dx technology?

Progenity plans to advance PIL Dx towards preclinical and clinical studies in 2021, aiming for commercialization.

Why is SIBO diagnosis important?

SIBO can lead to over 100 million patient visits annually in the US, and current diagnostic methods are often invasive or inaccurate.