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Novel Algorithm for Free Testosterone Determination

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AG045011-01A1
Agency Tracking Number: R43AG045011
Amount: $225,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PA13-088
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
221 Longwood Ave
BOSTON, MA 02115-5804
United States
DUNS: 78274054
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (323) 563-4800
Business Contact
Phone: (617) 797-2888
Research Institution

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

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