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A Non-Invasive Test for Predicting the Fertility Window

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HD053169-01
Agency Tracking Number: HD053169
Amount: $113,393.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: PHS2006-2
Solicitation Year: 2006
Award Year: 2006
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (856) 231-9922
Business Contact
Phone: (856) 231-1328
Research Institution

DESCRIPTION (provided by applicant): The objective of this research is to develop a non-invasive test strip for the prediction of a women's fertility window. This test will be based on the semi-quantitative colorimetric determination of salivary divalent cations. The test will be simple-to-use, inexpensive, provide the accuracy of costly instruments and can be used in the in the clinic or home setting. PortaScience has investigated changes in concentrations of salivary electrolytes during a female's fertile period and determined that there is a translocation of divalent cations (specifically Mg++ and Ca++) away from the salivary glands. This translocation of cations occurs during a female's fertile period, three to four days prior to ovulation. This drop in concentration of cations can be used as an effective biomarker to predict a women's fertility period. The specific aims of this investigation are: Aim 1: Select a dye substrate that provides the sensitivity to detect 250 uM Mg++/Ca++; Aim 2: Identify stabilizers and membrane material for protecting the dye substrates; and Aim 3: Build and evaluate the performance of test strips and define specifications for performance. The potential US market for fertility monitoring is 500 million dollars.

* Information listed above is at the time of submission. *

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