SBIR-STTR Award

Novel Devices for Management of Toxic Alcohol Exposure
Award last edited on: 10/16/07

Sponsored Program
SBIR
Awarding Agency
NIH : NIGMS
Total Award Amount
$845,598
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Hans Kloepfer

Company Information

Micronix Inc

766 Woodview South Drive
Carmel, IN 46032
   (317) 844-4324
   micronixinc@earthlink.net
   N/A
Location: Single
Congr. District: 05
County: Hamilton

Phase I

Contract Number: 1R43GM062145-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2000
Phase I Amount
$100,000
Poisoning from methanol is a potentially life threatening medical emergency that can cause multi-organ failure and permanent visual impairment. For the next century, methanol has been proposed as an alternative, environmentally cleaner automotive fuel. Since other industrial uses of methanol are also expected to expand, the incidence of poisonings is likely to increase. Methanol is metabolized in vivo to formic acid (formate), the major toxic metabolite. The only affirmative diagnostic tool is determination of blood levels of methanol or formate. Unfortunately, access to testing for methanol is restricted, and for formate essentially non-existent. This leaves practitioners with relatively unspecific physical signs and surrogate laboratory tests to make the diagnosis. As numerous other conditions can lead to anion/osmolol gap acidosis, diagnosis can be enshrouded in mystery. The applicant proposes to develop specific enzymic methods for blood methanol and formate for use on existing clinical analyzers and at the patient point-of-care (POC). The POC method is a dual-analyte test tab device for the simultaneous estimation of methanol and formate from approximately two microliters of whole blood without centrifugation or any other form of sample or reagent handling. PROPOSED COMMERCIAL APPLICATION: Poisoning from methanol can lead to permanent visual impairment and death. Acidosis from formic acid needs to be differentiated from other forms of metabolic acidosis. Assay of methanol is currently done by semi-quantitative gas chromatographic (GC) "volatile screens", following by confirmatory analysis by GC or GC/MS. These methods are not available in most labs. Testing for formate is esentially non-existent. No clinical analyzer currently offers either a methanol or formate method. The proposed products would solve these problems

Phase II

Contract Number: 2R44GM062145-02A2
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2005
(last award dollars: 2006)
Phase II Amount
$745,598

The applicant organization proposes to develop ultra-miniaturized, minimally invasive test wand methods for quantification in whole blood specimens of methanol, formate, ethylene glycol, and glycolate, the four critical analytes in the laboratory evaluation of toxic alcohol exposure. The methods dose and transport a blood sample in the nanoliter range to an integrated polymeric detection site. The detection site embodies dried chemical reagents capable of reacting with analyte, as well as a polymeric composition capable of absorbing a defined volume of blood plasma while preventing cellular component of blood from penetrating the composition. Cells are wholly removed from the detection site by proprietary chemical and physical mechanisms, thereby obviating the need for a separate cell-filtering material and unmasking the detection site for instrumented or visual analysis. Instrumented analysis is performed by means of a hand-held transmittance monitoring meter. Test procedure and performance time are streamlined by consolidating all testing steps into one single disposable device. Primary target markets are emergency room and other critical care environments