FUNCTION PROMOTING THERAPIES LLC — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): The measurement of testosterone levels is central to
FUNCTION PROMOTING THERAPIES LLC — SBIR Phase I award from Department of Health and Human Services.
- Amount
- $225,000
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase I
- Solicitation
- PA13-088
- NAICS
- —
- Place of performance
- MA
- Period
- —
Description
DESCRIPTION (provided by applicant): The measurement of testosterone levels is central to the diagnosis of androgen disorders in men and women. Circulating testosterone is bound largely to sex hormone binding globulin (SHBG) and albumin; only the unbound or free fraction is biologically active. Therefore, in conditions that affect SHBG concentrations, such as aging, obesity, and diabetes, the determination of free testosterone is necessary to obtain an accurate assessment of androgen status. The current methods for the determination of free testosterone - equilibrium dialysis, ultrafiltration, tracer analog methods, and the use of algorithms based on the law-of-mass-action - suffer from problems of imprecision or inaccuracy. Equilibrium dialysis method, widely considered the reference method, is labor-intensive and cumbersome, and susceptible to errors due to tracer impurities, leading the Endocrine Society's Expert Panel to conclude that ...the calculation of free testosterone is the most useful estima