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BOSTON, MA, United States

The invention relates to a colorimetric method for detecting bacterial or fungal pathogens by detecting peptidoglycan or (1-3)--D-glucan in a sample.

Immunetics, Inc. | Date: 2012-10-22

The invention is directed to methods of using novel

Immunetics, Inc. | Date: 2014-10-14

Assay devices, assay detection systems, and methods comprising same for analytical tests, medical assays, diagnostic tests, medical diagnosis, risk assessment, or quality control purposes are provided. These devices, systems, and methods are designed to be employed at the point of care, such as in emergency rooms, operating rooms, hospital laboratories and other clinical laboratories, doctors offices, in the field, or in any situation in which a rapid and accurate result is desired. The systems and methods process samples, such as clinical, biological, or blood sample, and read data from colorimetric based biochemical assays to provide an indication of the presence or absence of a bacterial, fungal, or viral contaminants therein. The assay devices include an optical reader apparatus and barcode scanner for reading and matching the test results to identification information provided by the barcodes to facilitate ease of tracking compliant and noncompliant samples.

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 3.61M | Year: 2015

DESCRIPTION provided by applicant In this Phase II project development and clinical validation of an ELISA test for in vitro diagnosis of Babesia microti infection will be completed Babesiosis is an emerging tick borne parasitic disease which may cause severe to fatal illness in immunocompromised or otherwise weakened patients and may be carried in the blood subclinically in up to of the population in endemic areas Recent cases of fatal transfusion transmitted babesiosis have also led to the identification of this pathogen as a significant threat to the blood supply However currently no commercial validated and FDA approved tests are available for B microti Babesiosis is currently diagnosed by immunofluorescence staining microscopy of blood smears and or PCR None of these procedures are easily adaptable to routine clinical laboratory use In Phase I we developed a microplate based ELISA using a mixture of novel synthetic B microti peptide antigens comprising immunodominant epitopes that were demonstrated to be diagnostically significant markers of infection The five peptide sequences were identified through screening of libraries of overlapping peptides derived from members of the BMN family of B microti proteins a group previously identified as highly immunoreactive against babesiosis patient sera Several of these peptides and epitopes have not previously been recognized as immunodominant and represent new discoveries Sensitivity of among confirmed babesiosis cases was achieved along with specificity above in low risk blood donors and other controls The peptides have been combined in a single well ELISA format using an innovative immobilization chemistry The prototype ELISA will be optimized with respect to peptide stoichiometry and all other assay parameters and scaled up for manufacturing in Phase II To validate assay performance a clinical study will be carried out in Phase II in which the B microti ELISA will be compared with PCR and blood smear which are considered gold standard assays for Babesia infection A retrospective clinical study will evaluate assay performance on well characterized samples from confirmed babesiosis cases while a prospective study will examine undiagnosed patients seen at tick borne disease clinics at three medical centers in regions of the Northeast and Midwest that are highly endemic for B microti The clinical study will determine the performance of the B microti ELISA vs PCR blood smear and immunofluorescence for diagnosis of B microti infection Results will be submitted in a k application to FDA for clearance of the B microti ELISA for in vitro diagnostic use PUBLIC HEALTH RELEVANCE Babesiosis is an emerging tick borne parasitic infection which can produce severe to fatal illness especially in immunocompromised or weakened patients However no FDA approved tests are currently available to aid in clinical diagnosis of this disease This project will lead to the development validation FDA approval and commercial availability of the first simple accurate and user friendly diagnostic test for babesiosis

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 972.24K | Year: 2016

DESCRIPTION provided by applicant Bacterial contamination of platelets is considered the greatest infectious risk of blood product transfusion today at about in platelet units which is several orders of magnitude greater than that of HIV Bacterial contamination at high levels can lead to severe morbidity or mortality in transfusion recipients The American Association of Blood Banks issued directives in and requiring bacterial testing on all platelet units Two recent studies have demonstrated that current FDA approved culture based methods that test for contamination to days prior to transfusion miss a majority of contaminated units The time elapsed between sampling and actual transfusion and the associated risk of bacterial contamination is a fundamental problem that cannot be addressed by current culture based platelet testing A rapid and sensitive point of issue test for bacterial contamination would overcome this problem by providing an assessment of potential contamination immediately prior to transfusion Such a test would be used by a hospital laboratory close to the point of transfusion or by a transfusion center preparing to ship platelet units to a clinical center A rapid test would ideally require less than min have detection sensitivity of CFU mL or better be fully automated and be comparable in cost to current tests BacTx technology developed by Immunetics for detection of bacterial contamination in platelets employs a unique and innovative assay chemistry capable of rapidly detecting both Gram positive and Gram negative bacteria in platelet units The first generation BacTx Bacterial Detection Kit recently received clearance from FDA CBER as a quality control test for pooled leukocyte reduced whole blood derived platelets but this test is not ideally suited for use as a point of issue test due to its length min and complexity requiring centrifugation and accurate pipetting In the Phase I project we successfully demonstrated feasibility of a simple filter based BacTx assay which is rapid andlt min and highly amenable to automation while maintaining the high sensitivity and specificity of the original BacTx test In Phase II we will optimize and configure the rapid test for automated performance and will design build and evaluate prototype instruments and software to run the test The instrument and software development will be carried out in collaboration with engineering partners who have many years of experience in the development of medical test systems with comparable functionality At the conclusion of Phase II we will have developed and validated an integrated rapid BacTx test system ready for clinical studies aimed at k approval Commercialization of this rapid test will enable a paradigm shift in platelet testing and a significant reduction in the number of bacterially contaminated platelet units transfused into critically ill patients Furthermore adopton of the rapid BacTx test could ultimately lead to a change in policy regarding platelets significantly reducing costs for blood banks by allowing an extension of the storage life of platelet units from to days PUBLIC HEALTH RELEVANCE Bacterial contamination of platelets is considered the greatest infectious risk of blood product transfusion today at about in platelet units which is several orders of magnitude greater than that of HIV We have developed a rapid andlt min point of transfusion screening test for detection of bacterial contamination in platelet units that meets or exceeds FDA guidelines We propose to adapt this test to be run by a simple automated device suitable for operation by non specialized personnel in a transfusion center or hospital laboratory Implementation of this rapid test will prevent severe or fatal septic transfusion reactions and lead to better health outcomes for critically ill patients receiving platelet transfusions

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