Association For Molecular Pathology et al v. United States Patent and Trademark Office et al

Filing 191

DECLARATION of Laura P. Masurovsky in Support re: 189 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)

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Association For Molecular Pathology et al v. United States Patent and Trademark Office et al Doc. 191 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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