AI for C. Difficile Identification

Findings on the Biotia Microbial Surveillance System

Nearly one half million Americans contract Clostridia difficile (C. difficile) infections each year making it the most common hospital acquired infection (HAI)

Strategies to reduce infections include improving infection control and healthcare facility cleaning/disinfection, especially to prevent further contamination within the hospital

The current gold-standard approaches for pathogen identification via culturing or PCR-based assays have critical limitations, impacting timely treatment and infection control measures

Biotia Leverages Genomics and AI to Provide Diagnostic Insights

Biotia is a next-generation sequencing (NGS) technology platform utilizing a curated database and artificial intelligence (AI) software to create an active surveillance system to detect both high-risk environments and high-risk patients.

Biotia rapidly identifies the full microbial profile of a sample including drug resistance and virulence markers. Their test can identify known and emerging bacteria, fungi, parasites and viruses from their clinically curated and annotated database of over 16,000 species, and generate antimicrobial resistance (AMR) genetic markers and virulence genetic markers.

Collect Sample

High-risk environments and patients are tested

Biotia data analysis

Biotia identifies the full microbial profile of the sample

Sequence DNA

DNA is extracted, processsed,
and sequenced

report

Biotia generates a report on the microbial profile

Between February 2019 and August 2019, HITLAB conducted a pilot study of the Biotia platform to evaluate its acceptability, feasibility, usability and perceived value by medical professionals/hospitalists.

Collected patient stool samples that tested positive for active C. difficile (n=25) were processed by Biotia to generate two reports – one via polymerase chain reaction (PCR)/enzyme immunoassay (EIA) and the other via Biotia software. Quantitative and qualitative data were collected from 13 medical professionals who typically request patient stool samples to assess for C. difficile infection to: 1) identify common clinical practices and limitations to the evaluation process of C. difficile infection, 2) compare content, relevance, and design of the two reports, and 3) discuss the potential value of Biotia to clinical practice.

"It’s clearly more information, but it is going to save the hospital money. That’s really top tier, the CMO, the corporate because it’s not only [one clinic site], they want the entire [hospital name] system to be consistent across the board."

—biotia study participant (MEDICAL PROFESSIONAL)

"the way they layout the information is very important, because we review a lot of reports per day. I want something with a clean design, something that highlights positive results so they’re immediately eye-catching in bold type."

—biotia study participant (MEDICAL PROFESSIONAL)

Improved specificity and result time are the largest areas of improvement for current C. difficile testing

which can reduce overtreatment and improve clinic flow.

Some participants felt the Biotia-generated report could be useful in tracking hospital C. difficile transmission

especially for infection control purposes.

Majority of participants would want to use the Biotia-generated report to help them diagnose C. difficile BY DISTINGUISHING BETWEEN COLONIZED AND INFECTED PATIENTS

Training on how to interpret the report will be an essential part of the implementation process,

i.e. in the form of in-services, webinars, lectures, handouts, and emails.

Participants identified key improvements needed to improve report relevance and readability

including reducing the report length and complexity, and prioritizing actionable information.

Implementation of Biotia into clinical settings requires additional considerations,

including cost, EMR integration, and alignment with multiple hospital entities/stakeholders.

recent developments

updated january 2020

December 2019

Over-subscribed venture capital seed raise of $2.4 million

December 2019

Expansion of the Clinical and Scientific Advisory Board

early 2020

Plan to launch CAP/CLIA clinical diagnostic tests

"there are a lot of uses for this that are not C. diff related for causes of unexplained diarrhea, persistent diarrhea and people on tube feeds."

—biotia study participant (MEDICAL PROFESSIONAL)

HITLAB Breakthrough Alliance was created to accelerate a greater number of digital health innovations through the generation of exclusive, evidence-based research and insights. This new digital health consortium is a subscription-based service with a mission to improve health outcomes and care delivery from verifying emerging technologies and research—driven by the perspectives and strategies of its members.

Making a difference in healthcare together, by accelerating evidence-based digital solutions.