MAYO CLINIC
Standard references methods are critically important for high quality laboratory measurements. Standardization and harmonization of test results values between medical centers and within medical centers over time has become increasingly important because of the mobility of patients and health care workers and restrictions on redundant testing. Also, the implementation of practice guidelines with global decision limits accentuates the importance of accurate standards and test harmonization. Two important analytes are prostate specific antigen (PSA) and testosterone. PSA test results are directly lined to clinical decisions for biopsy of the prostate gland to diagnose prostate cancer: false high values may cause extra biopsies and false low values may result in failure to diagnose prostate cancer [1-3]. Accurate measurements of steroid hormones, especially testosterone, estradiol, and dihydrotestosterone, are important for assessing disease risks and dosing of exogeneous hormone replacement [4-9]. The goals of this grant proposal are to develop robust reference methods for measuring PSA and the biologic activity of sex steroids [testosterone (T), estradiol (E2), and dihydrotestoterone (DHT)] in human blood and to demonstrate the clinical utility of these procedures for diagnosing prostate cancer and assessing metabolic disorders of androgen and estrogen metabolism.
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| AWARD OVERVIEW |
| Award Number |
60NANB10D005 |
Funding Agency |
Department of Commerce |
| Total Award Amount |
$1,496,654 |
Project Location - City |
Rochester |
| Award Date |
01/08/2010 |
Project Location - State |
MN |
| Project Status |
Completed |
Project Location - Zip |
55905-0002
|
| Jobs Reported |
2.08 |
Congressional District |
01 |
| Project Location - Country |
US |
|
|
Recipient Information
(Grants)
| Recipient Information (Grants) |
|
Recipient Name
|
MAYO CLINIC |
| Recipient DUNS Number |
006471700
|
| Recipient Address |
200 1ST ST SW |
| Recipient City |
ROCHESTER |
| Recipient State |
Minnesota |
| Recipient Zip |
55905-0002 |
| Recipient Congressional District |
01 |
| Recipient Country |
USA |
Required to Report Top 5
Highly Compensated Officials |
No |
Projects and Jobs Information
| Projects and Jobs Information |
| Project Title |
Development of Reference Methods for Measuring PSA and Activities for Sex Steroids |
| Project Status |
Completed |
| Final Project Report Submitted |
Yes |
| Project Activities Description |
General Science |
| Quarterly Activities/Project Description |
Progress on this grant continued through the end of the funding on Jan. 31, after that work has continued on reports and manuscripts.
An investigator at Lund U. in Sweden reported up to 10% of their population has a single nucleotide polymorphism in with an alteration in the Leucin Serine Glutamic Acid (LSE) peptide in the prostate specific antigen (PSA) molecule. Since we have selected the LSE peptide for quantitation of PSA with our reference method, we investigated how this mutation would affect our assay. We had the variant form of the peptide synthesized and compared it to the native peptide and the internal standard we made for our mass spectrometry system. With our chromatography, all three compounds have very close retention time. Therefore this should not cause a problem with our reference method for PSA.
We continued our work on the BiaCore with immobilized dihydrotestosterone, testosterone, and estradiol. We used this process to measure the affinity constants for the binding of Sex Hormone Binding Globulin (SHBG) found in serum samples from the subjects collected in the Veldhuis series for the remaining 140 subjects. The combined cross plots were made showing the association constants for dihydrotestosterone and testosterone versus age.
We have analyzed the correlations and predictive relationships between the measured concentrations and activities of the sex steroids and the metabolic status. The following table illustrates some of these relationships.
We established a repository of aliquots of specimens with assigned reference values, which includes a panel of twenty, 0.5 mL plasma aliquots from 3 men and 17 women with assigned values for reference concentrations of dihydrotestosterone, testosterone, and estradiol. We also made a panel of ten,1.0 mL aliquots from 10 men and 10 women with assigned values for dihydrotestosterone, testosterone, estradiol and SHBG, plus calculated values for the activities of the sex steroids. |
| Jobs Created |
2.08 |
| Description of Jobs Created |
Investigator 0.06, Investigator 0.01, Resident .67, Research Technician 0.67, Research Technician 0.67 |
Purchaser Information
(Grants)
| Purchaser Information |
| Contracting Office ID |
Not Reported |
| Contracting Office Name |
Not Available |
| Contracting Office Region |
Not Available |
| TAS Major Program |
13-0549 |
| Award Information |
| Award Date |
01/08/2010 |
| Award Number |
60NANB10D005 |
| Order Number |
|
| Award Type |
Grants |
| Funding Agency ID |
13 |
| Funding Agency Name |
Department of Commerce |
| Funding Office Name |
Not Available |
| Awarding Agency ID |
13 |
| Awarding Agency Name |
Department of Commerce |
| Amount of Award |
$1,496,654 |
| Funds Invoiced/Received |
$1,496,654 |
| Expenditure Amount |
$1,496,654 |
| Infrastructure Expenditure Amount |
$0 |
| Infrastructure Purpose and Rationale |
Not Reported |
| Infrastructure Point of Contact Name |
Not Reported |
| Infrastructure Point of Contact Email |
Not Reported |
| Infrastructure Point of Contact Phone |
Not Reported |
| Infrastructure Point of Contact Address |
Not Reported |
| Infrastructure Point of Contact City |
Not Reported |
| Infrastructure Point of Contact State |
Not Reported |
| Infrastructure Point of Contact Zip |
Not Reported |
Product or Service Information
(Grants)
| Product or Service Information |
| Primary Activity Code |
U20 - NTEE |
| Activity Description |
General Science |
| Sub-Awards Information |
| Sub-awards to Organizations |
0 |
| Sub-award Amounts to Organizations |
$0 |
| Sub-Awards to Individuals |
0 |
| Sub-Award Amounts to Individuals |
$0 |
| Number of Sub-awards less than $25,000/award |
0 |
| Amount of Sub-awards less than $25,000/award |
$0 |
| Number of payments to vendors greater than $25,000 |
2 |
| Total Amount of payments to vendors greater than $25,000/award |
$98,653 |
| Number of payments to vendors less than $25,000/award |
195 |
| Total Amount of payments to vendors less than $25,000/award |
$192,675 |
FISHER SCIENTIFIC COMPANY LLC - Award Number 60NANB10D005 - FISHER SCIENTIFIC COMPANY LLC
| Award Number |
60NANB10D005 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
Not reported |
| Vendor HQ Zip Code + 4 |
60133-5491 |
| Vendor Name |
FISHER SCIENTIFIC COMPANY LLC |
| Product and Service Description |
Kingfisher Flex W/96 PCR Head, Magnetic Particle Processor |
| Payment Amount |
$48,653 |
SISCAPA Assay Technologies, Inc. - Award Number 60NANB10D005 - SISCAPA Assay Technologies, Inc.
| Award Number |
60NANB10D005 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
45-297285 |
| Vendor HQ Zip Code + 4 |
20009-1718 |
| Vendor Name |
SISCAPA Assay Technologies, Inc. |
| Product and Service Description |
Monoclonal Antibodies - 2 Payments will be made in the amount of $25,000 to total $50,000. |
| Payment Amount |
$50,000 |
| Location Information |
| Latitude, Longitude |
44º 1' 20",
-92º 27' 54" |
| Congressional District |
01 |
| Address 1 |
200 First Street SW |
| Address 2 |
|
| City |
Rochester |
| County |
Olmsted |
| State |
MN |
| Zip |
55905-0002 |
|
 |