Association For Molecular Pathology et al v. United States Patent and Trademark Office et al
Filing
188
FILING ERROR - DEFICIENT DOCKET ENTRY - DECLARATION of Laura P. Masurovsky in Support re: 186 MOTION to File Amicus Brief. Document filed by Genetic Alliance. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6)(Masurovsky, Laura) Modified on 12/31/2009 (db).
Association For Molecular Pathology et al v. United States Patent and Trademark Office et al
Doc. 188 Att. 6
Exhibit 6
Dockets.Justia.com
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Ass... Page 1 of 14
Vaccines, Blood & Biologics Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
Return to the Infectious Disease Tests page Antibody to Hepatitis B Surface Antigen (HBsAg Assay)
Tradename (s) Auszyme Monoclonal EIA
Format
Sample
Use
Manufacturer Approval Date Abbott Laboratories Abbott Park, IL US License 0043 4/1/1985
S erum / Plasma / Cadaveric Serum
Donor Screen & Conf Kit
GS HBsAg EIA 3.0
EIA
S erum / Plasma / Cadaveric Serum Serum / Plasma
Donor Screen & Conf Kit
Bio-Rad 1/23/2003 Laboratories Redmond, WA US License 1109 Ortho-Clinical Diagnostics, Inc Raritan, NJ US License 1236 Abbott Laboratories Abbott Park, IL US License 0043 4/23/2003
ORTHO Antibody to HBsAg ELISA Test System 3
EIA
Donor Screen / Diagnosis & Conf Kit
Chemiluminescent Serum/Plasma ABBOTT Immunoassay PRISM (ChLIA) HBsAg ABBOTT PRISM HBsAg Confirmatory
Donor screening test to detect HBsAg. Also for use in testing blood and plasma to screen organ donors when
7/18/2006
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/Li...
12/28/2009
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Ass... Page 5 of 14
Nucleic Acid Testing
Tradename(s) Format Sample Use Manufacturer App D Roche Molecular Systems, Inc Pleasanton, CA bioMerieux, Inc Durham, NC 3/2/1
Roche Amplicor HIV-1 Monitor Test
PCR
Plasma
Prognosis / Patient Management HIV-1 Viral Load Assay Prognosis / Patient Management HIV-1 Viral Load Assay Donor Screen Expanded Indications For Use: Source Plasma donors, other living donors, and organ donors Donor Screen Expanded Indications For Use: Source Plasma donors, living organ donors and cadaveric samples
NucliSens HIV-1 QT
NASBA
Plasma
11/19
COBAS Ampliscreen HIV1 Test
PCR
Plasma
Roche Molecular Systems, Inc Pleasanton, CA US License 1636
12/20
Procleix HIV1/HCV Assay
HIV-1/HCV Plasma Nucleic Acid Test (TMA)
Gen-Probe 6/4/2 San Diego, CA US License 1592
Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System UltraQual HIV-1 RT-PCR Assay
HIV-1 Genotyping
Plasma
Patient Monitoring Siemens Medical Solutions Diagnostics Berkeley, CA Donor Screen National Genetics Institute Los Angeles, CA 92121 National Genetics Institute
4/24/
PCR
Plasma
9/18/
UltraQual HCV RTPCR Assay
PCR
Plasma
Donor Screen
9/18/
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/Li...
12/28/2009
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Ass... Page 6 of 14
Los Angeles, CA 92121 ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer Versant HIV-1 RNA 3.0 (bDNA) HIV-1 Genotyping Plasma Patient Monitoring Celera Diagnostics Alameda, CA 6/11/
Signal amplification nucleic acid probe
Plasma
Patient Monitoring
Siemens Medical Solutions Diagnostics Berkeley, CA
9/11/
COBAS AmpliScreen HCV Test
PCR
Plasma
Donor Screen Expanded Indications For Use: Source Plasma donors, other living donors, and organ donors Donor Screen Indications For Use: Source Plasma donors, other living donors, and organ donors Qualitative detection of West Nile Virus (WNV) RNA from volunteer donors of whole blood and blood components, screen organ donors when obtained while donor's heart is still beating, and test blood specimens to screen cadaveric donors
Roche Molecular Systems, Inc Pleasanton, CA US License 1636 Roche Molecular Systems, Inc Pleasanton, CA US License 1636
12/3/
COBAS AmpliScreen HBV Test
PCR
Plasma
4/21/
Nucleic Acid Test Plasma Procleix West Nile (TMA) Virus (WNV) Assay
Gen-Probe 12/1/ San Diego, CA US License 1592
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/Li...
12/28/2009
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Ass... Page 7 of 14
APTIMA HIV-1 RNA Qualitative Assay
HIV-1 and Plasma HCV/Nucleic Acid Pooled Testing/Synthetic Nucleic Acid Test Plasma (TMA) and Serum
For use as an aid in diagnosis of HIV-1 infection, including acute or primary infection. Qualitative detection of human immunodeficiency virus type 1 (HIV1) RNA and hepatitis C virus (HCV) RNA from volunteer donors of whole blood and blood components, screen organ donors when obtained while donor's heart is still beating, and test blood specimens to screen cadaveric donors. 8/12/2008 Additional Indication: Revision of Intended Use to include an HBV screening claim for individual samples and pooled samples of up to 16 individual donations. An Intended Use to include testing of pools of up to 16 donations from donors of Hematopoietic Progenitor Cells (HPCs) or Donor Lymphocytes for Infusion (DLI).
Gen-Probe, Inc US License 1592
10/4/
Procleix Ultrio Assay
Gen-Probe 10/3/ San Diego, CA US License 1592
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/Li...
12/28/2009
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Ass... Page 8 of 14
Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay
PCR
Plasma
Qualitative detection of HCV ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. Qualitative detection of HIV1 ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples.
BioLife Plasma 2/9/2 Services, L.P. Deerfield, IL US License 1640
Human Immunodeficiency Virus, Type 1 (HIV -1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) Assay
PCR
Plasma
BioLife Plasma 1/31/ Services, L.P. Deerfield, IL US License 1640
Abbott RealTime HIV-1 Amplification Kit
PCR
Plasma
Quantitation of 5/11/ ABBOTT Human Molecular, Inc Immunodeficiency Des Plaines, IL Virus type 1 (HIV1) on the automated m2000 System. Not intended to be used as a donor screening test. Quantitation of Human Immunodeficiency Virus Type 1 (HIV -1) nucleic acid. Not intended to be used as a donor screening test. For the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood Roche Molecular Systems, Inc Pleasanton, CA 5/11/
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test
PCR
Plasma
COBAS TaqScreen West Nile Virus Test
PCR
Plasma
Roche Molecular Systems, Inc Pleasanton, CA US License 1636
8/28/
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/Li...
12/28/2009
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Ass... Page 9 of 14
components, and other living donors. Also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating.
Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)
Tradename (s) GS rLAV EIA Format Sample Use Manufacturer Approval Date
EIA
Serum / Plasma
Donor Screen Bio-Rad 6/29/1998 Laboratories Redmond, WA US License 1109 Donor Calypte Supplemental Biomedical Corp Berkeley, CA US License 1207 1/3/1991
Cambridge Biotech HIV -1 Western Blot Kit
WB
Serum / Plasma
GS HIV-1 Western Blot
WB
Serum / Plasma
Donor Bio-Rad 11/13/1998 Supplemental Laboratories Redmond, WA US License 1109 Donor Waldheim 2/5/1992 Supplemental Pharmazeutika GmbH Vienna, Austria US License 1150 Diagnostic Abbott Laboratories 4/22/1992
Fluorognost HIV-1 IFA
IFA
Serum / Plasma
HIVAB HIV1 EIA
EIA
Dried Blood Spot
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/Li...
12/28/2009
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