SALT LAKE CITY, UT, United States

Biofire Diagnostics, Inc.

www.biofiredx.com
SALT LAKE CITY, UT, United States
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Patent
Biofire Diagnostics, Inc. | Date: 2017-01-05

Devices and methods are provided for spotting an array with fluid. Arrays produced by such methods are also provided. In one aspect of the invention, a spotter device for spotting a plurality of fluids into an array is described, the spotter device comprising a plurality of reservoirs provided in a first configuration, each reservoir holding its respective fluid, a print head having a plurality of positions provided in a second configuration, the second configuration being different from the first configuration, a plurality of tubes, each tube configured to provide fluid communication from a reservoir at a first end of the tube to a position in the print head at the second end of the tube, and a pump for pumping fluid through the tubes from the reservoir to the print head.


Patent
Biofire Diagnostics, Inc. | Date: 2016-11-01

Devices and methods are provided for collecting and handling difficult sample types.


Patent
Biofire Diagnostics, Inc. and University of Utah | Date: 2015-11-11

Methods for typing a strain of an organism are provided, the methods comprising the steps of amplifying, in a single reaction mixture containing nucleic acid from the organism, dividing the reaction mixture into a plurality of sets of second-stage reaction wells, each set of second-stage reaction wells containing a different pair of second-stage primers, subjecting each of the second-stage reaction wells to amplification conditions to generate a plurality of second-stage amplicons, melting the second-stage amplicons to generate a melting curve for each second-stage amplicon, and identifying the strain of the organism from the melting curves.


Patent
Biofire Diagnostics, Inc. and University of Utah | Date: 2014-11-05

Methods, devices, and kits are provided for performing PCR and other thermal cycling reactions in <20 seconds per cycle, using induction heating.


Patent
Biofire Diagnostics, Inc. and University of Utah | Date: 2016-01-20

An experimental melting curve is modeled as a sum of a true melting curve and background fluorescence. A deviation function may be generated based upon the experimental melting curve data and a model of a background signal. The deviation function may be generated by segmenting a range of the experimental curve into a plurality of windows. Within each window, a fit between the model of the background signal and the experimental melting curve data may be calculated. The deviation function may be formed from the resulting fit parameters. The deviation function may include background signal compensation and, as such, may be used in various melting curve analysis operations, such as data visualization, clustering, genotyping, scanning, negative sample removal, and the like. The deviation function may be used to seed an automated background correction process. A background-corrected melting curve may be further processed to remove an aggregation signal.


Patent
Biofire Diagnostics, Inc. | Date: 2013-04-17

Devices and methods are provided for spotting an array with fluid. Arrays produced by such methods are also provided. In one aspect of the invention, a spotter device for spotting a plurality of fluids into an array is described, the spotter device comprising a plurality of reservoirs provided in a first configuration, each reservoir holding its respective fluid, a print head having a plurality of positions provided in a second configuration, the second configuration being different from the first configuration, a plurality of tubes, each tube configured to provide fluid communication from a reservoir at a first end of the tube to a position in the print head at the second end of the tube, and a pump for pumping fluid through the tubes from the reservoir to the print head.


Patent
Biofire Diagnostics, Inc. | Date: 2014-12-12

Devices, containers, and methods are provided for performing biological analysis in a closed environment. Illustrative biological analyses include nucleic acid amplification and detection and immuno-PCR.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 452.63K | Year: 2013

DESCRIPTION (provided by applicant): Meningitis and encephalitis are inflammatory, often infectious, processes of the central nervous system that can result in significant morbidity and mortality. Prompt, appropriate therapy is crucial, but determining theinfectious etiology can be difficult and time-consuming. A wide-range of pathogens can be involved including both bacteria and viruses. Culture is the standard for diagnosis of bacterial Meningoencephalitis (ME), PCR of viral nucleic acid is the standardfor aseptic causes. However the current methods are either 1) too slow to be clinically relevant; 2) technically complex; 3) limited in the number of targets r 4) not cleared by the FDA. Idaho Technology (ITI) has developed a lab in a pouch PCR-based diagnostic system termed FilmArray that is rapid, easy to use, and can test for large panels of infectious agents simultaneously. A FilmArray pouch that can detect 15 respiratory pathogens was cleared by the FDA as a CLIA moderate complexity test. We propose to apply the FilmArray technology to the problem of ME diagnosis. SA1: Develop a FilmArray Meningoencephalitis (FAME) panel: We will construct a FilmArray pouch that combines PCR assays from existing panels with five new assays to detect the following ME-causing organisms directly from cerebrospinal fluid (CSF): Enterobacteriaceae, E. coli, Enterococcus species, H. influenza, L. monocytogenes, Mycoplasma pneumoniae, N. meningitidis, P. aeruginosa, Staphylococci species, S. aureus, Streptococcus species, S. agalactiae, S. pneumoniae, S. pyogenes, viridians streptococci, Adenovirus, Enterovirus, Parechovirus, HSV1, HSV2, VZV, EBV, CMV, HHV-6. SA2: Optimize nucleic acid extraction for virus and bacteria from CSF: CSF is one of the less complex sample matrices that have been processed on the FilmArray (when compared to nasal swabs, blood culture and stool). However, detecting bacteria, and virus, directly from CSF, may require the highest possible sensitivity. We will optimize the nucleic acid purificationsteps internal to the pouch as well as investigate simple steps to concentrate bacteria and viruses before the pouch SA3: Test the FAME panel on 300 CSF samples: Our collaborators will test CSF samples from pediatric and adult patients with suspected ME. We will compare these results to their standard assays performed on the samples, supplemented with the results of the comparator assays described in SA1. A successful outcome of this proposal will be a FilmArray pouch capable of detecting and identifying the common ME pathogens. It will be ready for the analytical and clinical trials necessary for a 510(k) submission to the FDA. This would be the subject of a future phase II submission. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Meningitis and encephalitis are life threatening inflammations of the brain and spinal cord which are often caused by infectious agents. Rapid, comprehensive, diagnosis of the virus or bacteria responsible for these conditions is critical for determining the most effective treatment. We will apply Idaho Technology's automated, multiplex nucleic acid test platform (the FilmArray) to the problem of meningoencephalitis diagnosis.


Optical systems and apparatuses configured for enabling substantially simultaneous observation of a plurality of points in an array from a common reference point. Without the optical systems and apparatuses disclosed herein, less than all of the plurality of points can be observed substantially simultaneously from the common reference point.


Patent
Biofire Diagnostics, Inc. | Date: 2013-02-12

Devices, containers, and methods are provided for performing biological analysis in a closed environment. Illustrative biological analyses include nucleic acid amplification and detection and immuno-PCR.

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