Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Development of a Novel Diagnostic Test for Pulmonary Embolism Based on Artificial Intelligence and Spectral Analysis of Blood

Award Number: R43HL154941
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2022

Group Awards By:

View Award Description

Development of a Novel Diagnostic Test for Pulmonary Embolism Based on Artificial Intelligence and Spectral Analysis of Blood - Pulmonary Embolism (PE) is a potentially life-threatening condition that affects adults of all ages yet can present with a myriad of symptoms, ranging from chest pain to shortness of breath, syncope, or seizure. Currently, physicians can assess for this condition with a blood test (D-dimer) which has high sensitivity but very poor specificity, thus resulting in a larger number of false positives. Alternatively, or in the case of a positive D-dimer, computed tomography pulmonary angiography (CTPA) or ventilation-perfusion (VQ) scan can be used, both of which are expensive and expose the patient to a significant amount of ionizing radiation. To develop a more specific blood test for PE, Biocogniv will apply state-of-the-art artificial intelligence (AI) to aggregate analysis of existing blood biomarkers measured on two commercially available multiplex immunoassay platforms, one of which is currently used in hospital labs. A sufficiently accurate, rapid and cost-effective test could be broadly applied (i.e., like troponin-I for myocardial infarction) to reduce overuse of CT, simplify ED decision making, and reduce the number of deaths from unrecognized PE. In this proposed Phase I single center study, Biocogniv will collaborate with the University of Vermont Medical Center (UVMMC) to demonstrate proof-of-concept for diagnosing PE in emergency department (ED) patients for whom there is sufficient concern for PE to warrant a D-dimer test as part of routine clinical care. Specific Aim I is to collect blood from 225 emergency department (ED) patients at UVMMC who were suspected of having PE (including 75 patients that are confirmed to have PE by CTPA), and analyze the blood plasma with quantitative immunoassays to create training and validation datasets for AI analysis. Immunoassays will be comprised of a set of 6 rapid FDA-cleared chemiluminescent immunoassays performed in parallel, and a 20-plex bead-based immunoassay panel targeting known cardiovascular and inflammatory markers associated with acute PE. Specific Aim II is to develop AI data models for two pretest populations—all D-dimer tested patients and just D-dimer positive patients—for bead-based and point-of-care immunoassay datasets (analyzed separately), then evaluate the performance of each data model on a subset of blood plasma data withheld for validation. As part of the evaluation of AI data model performance, the potential impact of study size on data model accuracy will be simulated by plotting specificity as a function of training sample number to show that adding more samples can improve test results. The performance of each approach (i.e., AI methodology applied to a given immunoassay panel for a given pretest population) will be compared and used to plan a Phase II multi-center study and to identify and attract a suitable instrumentation partner. Biocogniv’s end goal is to develop a rapid, highly specific and sensitive FDA cleared test for PE that will become the standard of care for initial diagnosis and triage of patients with potential pulmonary embolism, disrupting the $2B/year D-Dimer market and improving ED patient care.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$148,749 )
2024	2020	BIOCOGNIV INC	50 LAKESIDE AVE., SUITE 851	BURLINGTON	VT	05401	CHITTENDEN	USA	Lung Diseases Research	000	1	10/12/2023	NEW	-$148,749
														Subtotal = -$148,749

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	BIOCOGNIV INC.	50 LAKESIDE AVE STE 851	BURLINGTON	VT	05401	CHITTENDEN	USA	Lung Diseases Research	000	1	11/18/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $299,749 )
2020	2020	BIOCOGNIV INC.	4 OAK HILL DR	SOUTH BURLINGTON	VT	05403	CHITTENDEN	USA	Lung Diseases Research	000	1	8/24/2020	NEW	$299,749
														Subtotal = $299,749

Grand Total All Awards = $151,000

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Development of a Novel Diagnostic Test for Pulmonary Embolism Based on Artificial Intelligence and Spectral Analysis of Blood

Award Number: R43HL154941

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2022

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer