Data, narratives and tools produced by the Kits' sector/GeneDxChart

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Type disease / drug tested genes patent holder and/or exclusive licensees Companies Number of US labs offering testing license key patents other patents product typical testing cost notes report links References
Dx Breast & Ovarian Cancer BRCA1 Myriad Genetics Myriad Genetics 1 exclusive 5753441, 6051379, BRACAnalysis $3120 [2] [1], [2] http://www.myriad.com/products/bracanalysis.php [1] Cook-Deegan et al. The dangers of diagnostic monopolies. Nature (2009) vol. 458 (7237) pp. 405-6
BRCA2 [2] SACGHS. Appendix 1: Compendium of Case Studies on the Impact of Gene Patents and Licensing Practices on Access to Genetic Testing. (2009) pp. 1-305
Dx colorectal cancer (HNPCC) MLH1 Oregon Health Sciences University + Dana Farber; Johns Hopkins Baylor, Boston University, City of Hope, Harvard, Huntington, Mayo Clinic, University of Pennsylvania, Quest, Myriad, ? ? 5922855, 5591826 (protein), 5693470 ? Myriad, MLH1 + MSH2 + MSH6: $2950; see [2] pg A-12 for more prices Cho M et al. Effect of patents and licenses on the provision of clinical genetic testing services. Journal of Molecular Diagnostics 2003 (February). 5(1):3-8. NB: FAP and HNPCC “patent enforcements” are more unlikely given non-exclusive licensing and multiple rights-holders. [1], [2] [3] Flockhart et al. Clinically available pharmacogenomics tests. Clinical pharmacology and therapeutics (2009) vol. 86 (1) pp. 109-13
MSH2
MSH6
Dx colorectal cancer (FAP) APC
MYH
Dx Alzheimer’s, late-onset (LOAD, AD2) APOE Duke university -> Athena Diagnostics (2 method patents for Dx alzheimer’s, don’t claim sequence, Bilski could destabilize; one claiming a kit) see [2]p B-6 Athena (St Louis Health Science Center offers cheaper APOE Dx for cardivascular disease; SunnyBrook Molecular Genetics Laboratory & McGill University Health Center provide APOE testing for AD for ~$100 canadian, [2]B-8) 1 exclusive 5508167, 5716828, 6027896 ADmark® ApoE Genotype Analysis & Interpretation (Symptomatic) $475 ($365 for cardiovascular sequencing by St Louis Health Science Center, see note) Cook-Deegan notes “penumbra effect” wrt Athena. Athena sublicensed APOE for DTC testing to Smart Genetics, but First Inventor on patent raised licensing complaints for ethical reasons ([2] B-16). APOE also is a marker for cardiovascular disease; testing for which does not infringe the methods patents, see [2]B-8; http://snpedia.com/index.php/Alzheimer's_disease. Also 2 testing labs in Canada, McGill and Sunnybrook both offer APOE testing for AD for $100 & $120 respectively [2]B-8. http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/qid/35
Alzheimer’s, early-onset (EOAD, AD3) PSEN1 Hospital for Sick Children, U Toronto -> Athena Athena 1 exclusive 6194153 5986054, 6531586, 6248555(dropped), ADmark® PS-1 DNA Sequencing Test $1675 ([2]B-15) http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1261
Alzheimer’s, early-onset (EOAD, AD4) PSEN2 Hospital for Sick Children -> Athena Athena 1 exclusive 5840540 6485911 ADmark® PS-2 DNA Sequencing Test $1500?* * http://www.alz.org/co/documents/2009_Symposium_handout_genetics.pdf http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1259
Alzheimer’s, early-onset (EOAD, AD1) APP ? Athena 2 ? ? ADmark® APP DNA Sequencing/Duplication Test; SignatureFISH $1000?* Signature genomics provides a FISH -based test for APP; only Athena does complete sequencing http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1260 http://www.signaturegenomics.com/signaturefish.html
Dx Haemochromatosis HFE Bio-Rad mDx Hereditary Hemochromatosis ASR kit; mDx Hereditary Hemochromatosis LLA ASR Merz JF, Kriss AG, Leonard DGB, Cho MK. Op. cit. Examine licensing activities around HFE and impact on diagnostic prices
Dx Cystic Fibrosis CFTR University of Michigan, Hospital for Sick Children 112 non-exclusive 5776677 5876974, 7118911, 6984487, 6730777, 5407796 Johns Hopkins also has some key CFTR patents.
Dx Long-QT syndrome PGxHealth; Bio-Reference Laboratories [1], [2]
Dx Spinocerebellar Ataxia Athena Diagnostics exclusive Cook-Deegan notes “penumbra effect” wrt Athena [1], [2]
Dx Tay-Sachs Disease [1], [2]
Dx Canavan Disease [1], [2]
PGx Coumadin (Warfarin) CYP2C9 Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test [3] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm
PGx Coumadin (Warfarin) VKORC1 [3]
PGx Sprycel (dasatinib) BCR-ABL [3] | Type disease / drug tested genes patent holder and/or exclusive licensees Companies Number of US labs offering testing license key patents other patents product typical testing cost notes report links References
Dx Breast & Ovarian Cancer BRCA1 Myriad Genetics Myriad Genetics 1 exclusive 5753441, 6051379, BRACAnalysis $3120 [2] [1], [2] http://www.myriad.com/products/bracanalysis.php [1] Cook-Deegan et al. The dangers of diagnostic monopolies. Nature (2009) vol. 458 (7237) pp. 405-6
BRCA2 [2] SACGHS. Appendix 1: Compendium of Case Studies on the Impact of Gene Patents and Licensing Practices on Access to Genetic Testing. (2009) pp. 1-305
Dx colorectal cancer (HNPCC) MLH1 Oregon Health Sciences University + Dana Farber; Johns Hopkins Baylor, Boston University, City of Hope, Harvard, Huntington, Mayo Clinic, University of Pennsylvania, Quest, Myriad, ? ? 5922855, 5591826 (protein), 5693470 ? Myriad, MLH1 + MSH2 + MSH6: $2950; see [2] pg A-12 for more prices Cho M et al. Effect of patents and licenses on the provision of clinical genetic testing services. Journal of Molecular Diagnostics 2003 (February). 5(1):3-8. NB: FAP and HNPCC “patent enforcements” are more unlikely given non-exclusive licensing and multiple rights-holders. [1], [2] [3] Flockhart et al. Clinically available pharmacogenomics tests. Clinical pharmacology and therapeutics (2009) vol. 86 (1) pp. 109-13
MSH2
MSH6
Dx colorectal cancer (FAP) APC
MYH
Dx Alzheimer’s, late-onset (LOAD, AD2) APOE Duke university -> Athena Diagnostics (2 method patents for Dx alzheimer’s, don’t claim sequence, Bilski could destabilize; one claiming a kit) see [2]p B-6 Athena (St Louis Health Science Center offers cheaper APOE Dx for cardivascular disease; SunnyBrook Molecular Genetics Laboratory & McGill University Health Center provide APOE testing for AD for ~$100 canadian, [2]B-8) 1 exclusive 5508167, 5716828, 6027896 ADmark® ApoE Genotype Analysis & Interpretation (Symptomatic) $475 ($365 for cardiovascular sequencing by St Louis Health Science Center, see note) Cook-Deegan notes “penumbra effect” wrt Athena. Athena sublicensed APOE for DTC testing to Smart Genetics, but First Inventor on patent raised licensing complaints for ethical reasons ([2] B-16). APOE also is a marker for cardiovascular disease; testing for which does not infringe the methods patents, see [2]B-8; http://snpedia.com/index.php/Alzheimer's_disease. Also 2 testing labs in Canada, McGill and Sunnybrook both offer APOE testing for AD for $100 & $120 respectively [2]B-8. http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/qid/35
Alzheimer’s, early-onset (EOAD, AD3) PSEN1 Hospital for Sick Children, U Toronto -> Athena Athena 1 exclusive 6194153 5986054, 6531586, 6248555(dropped), ADmark® PS-1 DNA Sequencing Test $1675 ([2]B-15) http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1261
Alzheimer’s, early-onset (EOAD, AD4) PSEN2 Hospital for Sick Children -> Athena Athena 1 exclusive 5840540 6485911 ADmark® PS-2 DNA Sequencing Test $1500?* * http://www.alz.org/co/documents/2009_Symposium_handout_genetics.pdf http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1259
Alzheimer’s, early-onset (EOAD, AD1) APP ? Athena 2 ? ? ADmark® APP DNA Sequencing/Duplication Test; SignatureFISH $1000?* Signature genomics provides a FISH -based test for APP; only Athena does complete sequencing http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1260 http://www.signaturegenomics.com/signaturefish.html
Dx Haemochromatosis HFE Bio-Rad mDx Hereditary Hemochromatosis ASR kit; mDx Hereditary Hemochromatosis LLA ASR Merz JF, Kriss AG, Leonard DGB, Cho MK. Op. cit. Examine licensing activities around HFE and impact on diagnostic prices
Dx Cystic Fibrosis CFTR University of Michigan, Hospital for Sick Children 112 non-exclusive 5776677 5876974, 7118911, 6984487, 6730777, 5407796 Johns Hopkins also has some key CFTR patents.
Dx Long-QT syndrome PGxHealth; Bio-Reference Laboratories [1], [2]
Dx Spinocerebellar Ataxia Athena Diagnostics exclusive Cook-Deegan notes “penumbra effect” wrt Athena [1], [2]
Dx Tay-Sachs Disease [1], [2]
Dx Canavan Disease [1], [2]
PGx Coumadin (Warfarin) CYP2C9 Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test [3] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm
PGx Coumadin (Warfarin) VKORC1 [3]
PGx Sprycel (dasatinib) BCR-ABL [3] -ype disease / drug tested genes patent holder and/or exclusive licensees Companies Number of US labs offering testing license key patents other patents product typical testing cost notes report links References
Dx Breast & Ovarian Cancer BRCA1 Myriad Genetics Myriad Genetics 1 exclusive 5753441, 6051379, BRACAnalysis $3120 [2] [1], [2] http://www.myriad.com/products/bracanalysis.php [1] Cook-Deegan et al. The dangers of diagnostic monopolies. Nature (2009) vol. 458 (7237) pp. 405-6
BRCA2 [2] SACGHS. Appendix 1: Compendium of Case Studies on the Impact of Gene Patents and Licensing Practices on Access to Genetic Testing. (2009) pp. 1-305
Dx colorectal cancer (HNPCC) MLH1 Oregon Health Sciences University + Dana Farber; Johns Hopkins Baylor, Boston University, City of Hope, Harvard, Huntington, Mayo Clinic, University of Pennsylvania, Quest, Myriad, ? ? 5922855, 5591826 (protein), 5693470 ? Myriad, MLH1 + MSH2 + MSH6: $2950; see [2] pg A-12 for more prices Cho M et al. Effect of patents and licenses on the provision of clinical genetic testing services. Journal of Molecular Diagnostics 2003 (February). 5(1):3-8. NB: FAP and HNPCC “patent enforcements” are more unlikely given non-exclusive licensing and multiple rights-holders. [1], [2] [3] Flockhart et al. Clinically available pharmacogenomics tests. Clinical pharmacology and therapeutics (2009) vol. 86 (1) pp. 109-13
MSH2
MSH6
Dx colorectal cancer (FAP) APC
MYH
Dx Alzheimer’s, late-onset (LOAD, AD2) APOE Duke university -> Athena Diagnostics (2 method patents for Dx alzheimer’s, don’t claim sequence, Bilski could destabilize; one claiming a kit) see [2]p B-6 Athena (St Louis Health Science Center offers cheaper APOE Dx for cardivascular disease; SunnyBrook Molecular Genetics Laboratory & McGill University Health Center provide APOE testing for AD for ~$100 canadian, [2]B-8) 1 exclusive 5508167, 5716828, 6027896 ADmark® ApoE Genotype Analysis & Interpretation (Symptomatic) $475 ($365 for cardiovascular sequencing by St Louis Health Science Center, see note) Cook-Deegan notes “penumbra effect” wrt Athena. Athena sublicensed APOE for DTC testing to Smart Genetics, but First Inventor on patent raised licensing complaints for ethical reasons ([2] B-16). APOE also is a marker for cardiovascular disease; testing for which does not infringe the methods patents, see [2]B-8; http://snpedia.com/index.php/Alzheimer's_disease. Also 2 testing labs in Canada, McGill and Sunnybrook both offer APOE testing for AD for $100 & $120 respectively [2]B-8. http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/qid/35
Alzheimer’s, early-onset (EOAD, AD3) PSEN1 Hospital for Sick Children, U Toronto -> Athena Athena 1 exclusive 6194153 5986054, 6531586, 6248555(dropped), ADmark® PS-1 DNA Sequencing Test $1675 ([2]B-15) http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1261
Alzheimer’s, early-onset (EOAD, AD4) PSEN2 Hospital for Sick Children -> Athena Athena 1 exclusive 5840540 6485911 ADmark® PS-2 DNA Sequencing Test $1500?* * http://www.alz.org/co/documents/2009_Symposium_handout_genetics.pdf http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1259
Alzheimer’s, early-onset (EOAD, AD1) APP ? Athena 2 ? ? ADmark® APP DNA Sequencing/Duplication Test; SignatureFISH $1000?* Signature genomics provides a FISH -based test for APP; only Athena does complete sequencing http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1260 http://www.signaturegenomics.com/signaturefish.html
Dx Haemochromatosis HFE Bio-Rad mDx Hereditary Hemochromatosis ASR kit; mDx Hereditary Hemochromatosis LLA ASR Merz JF, Kriss AG, Leonard DGB, Cho MK. Op. cit. Examine licensing activities around HFE and impact on diagnostic prices
Dx Cystic Fibrosis CFTR University of Michigan, Hospital for Sick Children 112 non-exclusive 5776677 5876974, 7118911, 6984487, 6730777, 5407796 Johns Hopkins also has some key CFTR patents.
Dx Long-QT syndrome PGxHealth; Bio-Reference Laboratories [1], [2]
Dx Spinocerebellar Ataxia Athena Diagnostics exclusive Cook-Deegan notes “penumbra effect” wrt Athena [1], [2]
Dx Tay-Sachs Disease [1], [2]
Dx Canavan Disease [1], [2]
PGx Coumadin (Warfarin) CYP2C9 Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test [3] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm
PGx Coumadin (Warfarin) VKORC1 [3]
PGx Sprycel (dasatinib) BCR-ABL [3] http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=11215

Notes:

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