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STAT Palm-Sized Blood Counter

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
R44HL099092
Solicitation Year:
2012
Solicitation Topic Code:
NHLBI
Solicitation Number:
PA11-096
Small Business Information
DNA MEDICINE INSTITUTE
727 Massachusetts Avenue Cambridge, MA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2012
Title: STAT Palm-Sized Blood Counter
Agency: HHS
Contract: 2R44HL099092-02
Award Amount: $972,576.00
 

Abstract:

DESCRIPTION (provided by applicant): The goal of this proposal is to develop a STAT palm-sized blood counter for monitoring complete blood counts (CBC) with 3-part differential during emergencies. Changes in blood counts can reflect acutely worsening medical conditions. For instance, a rapidly rising white blood cell count may occur during infections or a leukemic blast crises. Hematocrit values may rapidly decline in traumas, gastrointestinal bleeds, and post- procedure recoveries. Platelet values may dropsignificantly during chemotherapy and idiopathic thrombocytopenic purpura. During these situations, close and frequent monitoring of a patient's blood counts is a must to deliver the best care and treatment, whether it be blood transfusions, platelet transfusions, or drug administrations. These clinical scenarios reflect a significant market need. In 2007, 2.7 billion of hematology tests were performed. Of these, an estimated 25-35% of these tests were STAT tests, which are ideally performed at the point-of-care. The proposed blood counter samples a fingerstick of blood from the patient and analyzes it in real-time at the patient's side for point-of-emergency clinical decision making. This is in contrast to today's measurement technologies, which require abenchtop instrument and a trained technician. The central hypothesis for this Phase II SBIR effort is this: microfluidic technology can be utilized to develop an integrated palm-sized blood counter that requires only a pinprick of blood. The proposed 24-month Phase II effort leverages our Phase I accomplishments in microfluidics, sensitive detection, and precision measurements to develop a prototype handheld emergency blood sensor. Advances in detection and microfluidics are required to develop such a device. Specific Aim 1 will utilize our microfluidics technology to assess serial cell dilution ad red cell lysis. Specific Aim 2 will be utilized to develop an integrated optical and electrical impedance detection system required for measurement of a wide range of cell parameters. Specific Aim 3 will be utilized to develop a handheld, breadboard prototype of our STAT blood counter and validate its performance against a gold-standard blood counter across a set of clinical samples. Success in Phase II will leadto a Phase III effort which will include detailed product engineering for a commercial STAT blood counter product, tests for FDA 510(k) approval, and commercialization. The resulting product can be utilized in a wide- range of settings including ambulances, inpatient rooms, operating rooms, medical offices, and resource- starved settings. PUBLIC HEALTH RELEVANCE: This research is relevant to public health because rapid diagnosis of blood counts can be the difference between life and death. The palm-sized blood counter is designed to provide much needed medical information during critical emergencies.

Principal Investigator:

Eugene Y. Chan
617-233-7656
echan@dnamedinstitute.com

Business Contact:

Eugene Y. Chan
617-233-7656
echan@dnamedinstitute.com
Small Business Information at Submission:

DNA MEDICINE INSTITUTE
727 Massachusetts Avenue Cambridge, MA -

EIN/Tax ID: 120209884
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No