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|SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.” | |SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.” | ||
|[3] | |[3] | ||
|http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm? | |http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?{| | | ||
| | |Type | ||
|disease / drug | |||
|genes | |||
|patent holder and/or exclusive licensees | |||
|Companies offering testing | |||
|Number of labs offering testing | |||
|license | |||
|key patents | |||
|product | |||
|typical testing cost | |||
|notes | |||
|report | |||
|links | |||
|References | |||
| | | | ||
| | | | ||
| | | | ||
|---- | |---- | ||
| | |Dx | ||
|breast & ovarian cancer | |||
|BRCA1, BRCA2 | |||
|Myriad Genetics | |||
| | |||
| | |||
| | |||
| | | | ||
|1 (Myriad’s CLIA lab) | |||
|exclusive | |||
|5753441, 6051379, | |||
|BRACAnalysis | |||
|$3120 [2] | |||
| | | | ||
|[1], [2] | |||
|http://www.myriad.com/products/bracanalysis.php | |||
|[1] CookDeegan:2009p405 | |||
| | | | ||
| | | | ||
| | | | ||
|---- | |---- | ||
| | |Dx | ||
|colorectal cancer (HNPCC) | |||
|MLH1, MSH2, MSH6 | |||
|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] | |||
| | | | ||
|[2] SACGHS:2009p1776 | |||
| | | | ||
| | | | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|colorectal cancer (FAP) | |||
|APC, MYH | |||
|Johns Hopkins | |||
|Myriad, Baylor, Harvard, Huntington, University of Pennsylvania, Boston University, Mayo Clinic | |||
| | | | ||
| | | | ||
|5352775 (APC), | |||
| | | | ||
|Myriad, MYH: $1795 [2] | |||
| | | | ||
|[1], [2] | |||
| | | | ||
| | |[3] Flockhart:2009p1728 | ||
| | | | ||
| | | | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|Alzheimers | |||
|PSEN1, PSEN2, APP (Early Onset AD); APOE | |||
|Duke university, Athena Diagnostics | |||
|Athena | |||
|1 (Athena); See [2] pg B-23 for list of others? | |||
|exclusive | |||
|APOE: 5508167, 5716828, 6027896; PSEN1: 6194153; PSEN2: 5840540 | |||
| | | | ||
| | |APOE: $475 ($365 for cardiovascular sequencing by St Louis Health Science Center); PSEN1: $1675; PSEN2: $2750 [2] | ||
| | |Cook-Deegan notes “penumbra effect” wrt Athena. Athena sublicensed APOE for DTC testing to Smart Genetics, but First Inventor on patent raised licensing complaints. APOE also is a marker for cardiovascular disease; for which testing would not infringe | ||
| | |[1], [2] | ||
| | | | ||
| | | | ||
Line 325: | Line 338: | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|Cystic Fibrosis | |||
|CFTR (âF508 most important; 1500 mutations known) | |||
| | | | ||
|University of Michigan; Hospital for Sick Children in Toronto; Johns Hopkins University | |||
|63 [1] | |||
|non-exclusive | |||
|5776677; 5876974; 6984487; 6730777; 7118911; | |||
| | | | ||
| | | | ||
| | |involved 10-year patent-interference proceedings [2] | ||
| | |[1], [2] | ||
| | | | ||
| | | | ||
Line 343: | Line 356: | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|Hearing Loss | |||
|GJB2/Connexin 26, GJB6/Connexin 30, SLC26A4/PDS, MTRNR1, and MTTS1 | |||
| | | | ||
| | | | ||
Line 351: | Line 367: | ||
| | | | ||
| | | | ||
| | |[1], [2] | ||
| | | | ||
| | | | ||
Line 361: | Line 374: | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|Haemochromatosis | |||
|HFE (C282Y, H63D mutations) | |||
|Bio-Rad | |||
|86 | |||
| | | | ||
| | | | ||
| | | | ||
|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 | ||
| | |[1], [2] | ||
| | |http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/2242?db=genetests | ||
| | | | ||
| | | | ||
Line 379: | Line 392: | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|Long-QT syndrome | |||
| | | | ||
|PGxHealth; Bio-Reference Laboratories | |||
| | | | ||
| | | | ||
Line 387: | Line 403: | ||
| | | | ||
| | | | ||
| | |[1], [2] | ||
| | | | ||
| | | | ||
Line 397: | Line 410: | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|Spinocerebellar Ataxia | |||
| | | | ||
|Athena Diagnostics | |||
| | | | ||
| | | | ||
|exclusive | |||
| | | | ||
| | | | ||
| | | | ||
| | |Cook-Deegan notes “penumbra effect” wrt Athena | ||
| | |[1], [2] | ||
| | | | ||
| | | | ||
Line 415: | Line 428: | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|Tay-Sachs Disease | |||
| | | | ||
| | | | ||
Line 424: | Line 439: | ||
| | | | ||
| | | | ||
| | |[1], [2] | ||
| | | | ||
| | | | ||
Line 433: | Line 446: | ||
| | | | ||
|---- | |---- | ||
|Dx | |||
|Canavan Disease | |||
| | | | ||
| | | | ||
Line 442: | Line 457: | ||
| | | | ||
| | | | ||
| | |[1], [2] | ||
| | | | ||
| | | | ||
Line 451: | Line 464: | ||
| | | | ||
|---- | |---- | ||
|PGx | |||
|Coumadin (Warfarin) | |||
|CYP2C9, VKORC1 | |||
| | | | ||
| | | | ||
Line 456: | Line 472: | ||
| | | | ||
| | | | ||
|Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test | |||
| | | | ||
| | | | ||
| | |[3] | ||
| | |http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm | ||
| | | | ||
| | | | ||
Line 469: | Line 482: | ||
| | | | ||
|---- | |---- | ||
|PGx | |||
|Sprycel (dasatinib) | |||
|BCR-ABL | |||
| | | | ||
| | | | ||
Line 476: | Line 492: | ||
| | | | ||
| | | | ||
|SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.” | |||
|[3] | |||
|http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?|-ype | |||
|disease / drug | |||
|genes | |||
|patent holder and/or exclusive licensees | |||
|Companies offering testing | |||
|Number of labs offering testing | |||
|license | |||
|key patents | |||
|product | |||
|typical testing cost | |||
|notes | |||
|report | |||
|links | |||
|References | |||
| | | | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|breast & ovarian cancer | |||
|BRCA1, BRCA2 | |||
|Myriad Genetics | |||
| | | | ||
|1 (Myriad’s CLIA lab) | |||
|exclusive | |||
|5753441, 6051379, | |||
|BRACAnalysis | |||
|$3120 [2] | |||
| | | | ||
|[1], [2] | |||
|http://www.myriad.com/products/bracanalysis.php | |||
|[1] CookDeegan:2009p405 | |||
| | | | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|colorectal cancer (HNPCC) | |||
|MLH1, MSH2, MSH6 | |||
|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] | |||
| | | | ||
|[2] SACGHS:2009p1776 | |||
| | | | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|colorectal cancer (FAP) | |||
|APC, MYH | |||
|Johns Hopkins | |||
|Myriad, Baylor, Harvard, Huntington, University of Pennsylvania, Boston University, Mayo Clinic | |||
| | | | ||
| | | | ||
|5352775 (APC), | |||
| | | | ||
|Myriad, MYH: $1795 [2] | |||
| | | | ||
|[1], [2] | |||
| | | | ||
|[3] Flockhart:2009p1728 | |||
| | | | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|Alzheimers | |||
|PSEN1, PSEN2, APP (Early Onset AD); APOE | |||
|Duke university, Athena Diagnostics | |||
|Athena | |||
|1 (Athena); See [2] pg B-23 for list of others? | |||
|exclusive | |||
|APOE: 5508167, 5716828, 6027896; PSEN1: 6194153; PSEN2: 5840540 | |||
| | | | ||
|- | |APOE: $475 ($365 for cardiovascular sequencing by St Louis Health Science Center); PSEN1: $1675; PSEN2: $2750 [2] | ||
|Cook-Deegan notes “penumbra effect” wrt Athena. Athena sublicensed APOE for DTC testing to Smart Genetics, but First Inventor on patent raised licensing complaints. APOE also is a marker for cardiovascular disease; for which testing would not infringe | |||
|[1], [2] | |||
| | | | ||
| | | | ||
Line 510: | Line 587: | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|Cystic Fibrosis | |||
|CFTR (âF508 most important; 1500 mutations known) | |||
| | | | ||
|University of Michigan; Hospital for Sick Children in Toronto; Johns Hopkins University | |||
|63 [1] | |||
|non-exclusive | |||
|5776677; 5876974; 6984487; 6730777; 7118911; | |||
| | | | ||
| | | | ||
|involved 10-year patent-interference proceedings [2] | |||
|[1], [2] | |||
| | | | ||
| | | | ||
Line 518: | Line 606: | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|Hearing Loss | |||
|GJB2/Connexin 26, GJB6/Connexin 30, SLC26A4/PDS, MTRNR1, and MTTS1 | |||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
|[1], [2] | |||
| | | | ||
| | | | ||
Line 532: | Line 625: | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|Haemochromatosis | |||
|HFE (C282Y, H63D mutations) | |||
|Bio-Rad | |||
|86 | |||
| | | | ||
| | | | ||
| | | | ||
|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 | |||
|[1], [2] | |||
|http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/2242?db=genetests | |||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
|--- | |- | ||
|- | |||
|Dx | |||
|Long-QT syndrome | |||
| | | | ||
|PGxHealth; Bio-Reference Laboratories | |||
| | | | ||
| | | | ||
Line 549: | Line 657: | ||
| | | | ||
| | | | ||
|[1], [2] | |||
| | | | ||
| | | | ||
Line 554: | Line 663: | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|Spinocerebellar Ataxia | |||
| | | | ||
|Athena Diagnostics | |||
| | | | ||
| | | | ||
|exclusive | |||
| | | | ||
| | | | ||
| | | | ||
|Cook-Deegan notes “penumbra effect” wrt Athena | |||
|[1], [2] | |||
| | | | ||
| | | | ||
Line 566: | Line 682: | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|Tay-Sachs Disease | |||
| | | | ||
| | | | ||
Line 575: | Line 695: | ||
| | | | ||
| | | | ||
|[1], [2] | |||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|Dx | |||
|Canavan Disease | |||
| | | | ||
| | | | ||
Line 590: | Line 714: | ||
| | | | ||
| | | | ||
|[1], [2] | |||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
|- | |||
|- | |||
|PGx | |||
|Coumadin (Warfarin) | |||
|CYP2C9, VKORC1 | |||
| | | | ||
| | | | ||
Line 601: | Line 730: | ||
| | | | ||
| | | | ||
|Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test | |||
| | | | ||
| | | | ||
|[3] | |||
|http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm | |||
| | | | ||
| | | | ||
| | | | ||
| | | | ||
| | |- | ||
| | |- | ||
| | |PGx | ||
| | |Sprycel (dasatinib) | ||
| | |BCR-ABL | ||
| | | | ||
| | | | ||
Line 626: | Line 751: | ||
| | | | ||
| | | | ||
|SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.” | |||
|[3] | |||
|http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=11215 | |||
| | | | ||
| | | | ||
Line 631: | Line 759: | ||
| | | | ||
|---- | |---- | ||
| | |OTC | ||
| | | | ||
| | | | ||
Line 649: | Line 777: | ||
| | | | ||
|---- | |---- | ||
| | |OTC | ||
| | | | ||
| | | | ||
Line 684: | Line 812: | ||
| | | | ||
| | | | ||
|} | |} | ||
Revision as of 17:57, 5 November 2009
List of Genetic Molecular Diagnostics from the literature
Type | disease / drug | genes | patent holder and/or exclusive licensees | Companies offering testing | Number of labs offering testing | license | key patents | product | typical testing cost | notes | report | links | References | ||||||||||||||||
Dx | breast & ovarian cancer | BRCA1, BRCA2 | Myriad Genetics | 1 (Myriad’s CLIA lab) | exclusive | 5753441, 6051379, | BRACAnalysis | $3120 [2] | [1], [2] | http://www.myriad.com/products/bracanalysis.php | [1] CookDeegan:2009p405 | ||||||||||||||||||
Dx | colorectal cancer (HNPCC) | MLH1, MSH2, MSH6 | 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] | [2] SACGHS:2009p1776 | ||||||||||||||||||||
Dx | colorectal cancer (FAP) | APC, MYH | Johns Hopkins | Myriad, Baylor, Harvard, Huntington, University of Pennsylvania, Boston University, Mayo Clinic | 5352775 (APC), | Myriad, MYH: $1795 [2] | [1], [2] | [3] Flockhart:2009p1728 | |||||||||||||||||||||
Dx | Alzheimers | PSEN1, PSEN2, APP (Early Onset AD); APOE | Duke university, Athena Diagnostics | Athena | 1 (Athena); See [2] pg B-23 for list of others? | exclusive | APOE: 5508167, 5716828, 6027896; PSEN1: 6194153; PSEN2: 5840540 | APOE: $475 ($365 for cardiovascular sequencing by St Louis Health Science Center); PSEN1: $1675; PSEN2: $2750 [2] | Cook-Deegan notes “penumbra effect” wrt Athena. Athena sublicensed APOE for DTC testing to Smart Genetics, but First Inventor on patent raised licensing complaints. APOE also is a marker for cardiovascular disease; for which testing would not infringe | [1], [2] | |||||||||||||||||||
Dx | Cystic Fibrosis | CFTR (âF508 most important; 1500 mutations known) | University of Michigan; Hospital for Sick Children in Toronto; Johns Hopkins University | 63 [1] | non-exclusive | 5776677; 5876974; 6984487; 6730777; 7118911; | involved 10-year patent-interference proceedings [2] | [1], [2] | |||||||||||||||||||||
Dx | Hearing Loss | GJB2/Connexin 26, GJB6/Connexin 30, SLC26A4/PDS, MTRNR1, and MTTS1 | [1], [2] | ||||||||||||||||||||||||||
Dx | Haemochromatosis | HFE (C282Y, H63D mutations) | Bio-Rad | 86 | 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 | [1], [2] | http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/2242?db=genetests | |||||||||||||||||||||
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, VKORC1 | Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test | [3] | http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm | ||||||||||||||||||||||||
PGx | Sprycel (dasatinib) | BCR-ABL | SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.” | [3] | | | Type | disease / drug | genes | patent holder and/or exclusive licensees | Companies offering testing | Number of labs offering testing | license | key patents | product | typical testing cost | notes | report | links | References | ||||||||||
Dx | breast & ovarian cancer | BRCA1, BRCA2 | Myriad Genetics | 1 (Myriad’s CLIA lab) | exclusive | 5753441, 6051379, | BRACAnalysis | $3120 [2] | [1], [2] | http://www.myriad.com/products/bracanalysis.php | [1] CookDeegan:2009p405 | ||||||||||||||||||
Dx | colorectal cancer (HNPCC) | MLH1, MSH2, MSH6 | 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] | [2] SACGHS:2009p1776 | ||||||||||||||||||||
Dx | colorectal cancer (FAP) | APC, MYH | Johns Hopkins | Myriad, Baylor, Harvard, Huntington, University of Pennsylvania, Boston University, Mayo Clinic | 5352775 (APC), | Myriad, MYH: $1795 [2] | [1], [2] | [3] Flockhart:2009p1728 | |||||||||||||||||||||
Dx | Alzheimers | PSEN1, PSEN2, APP (Early Onset AD); APOE | Duke university, Athena Diagnostics | Athena | 1 (Athena); See [2] pg B-23 for list of others? | exclusive | APOE: 5508167, 5716828, 6027896; PSEN1: 6194153; PSEN2: 5840540 | APOE: $475 ($365 for cardiovascular sequencing by St Louis Health Science Center); PSEN1: $1675; PSEN2: $2750 [2] | Cook-Deegan notes “penumbra effect” wrt Athena. Athena sublicensed APOE for DTC testing to Smart Genetics, but First Inventor on patent raised licensing complaints. APOE also is a marker for cardiovascular disease; for which testing would not infringe | [1], [2] | |||||||||||||||||||
Dx | Cystic Fibrosis | CFTR (âF508 most important; 1500 mutations known) | University of Michigan; Hospital for Sick Children in Toronto; Johns Hopkins University | 63 [1] | non-exclusive | 5776677; 5876974; 6984487; 6730777; 7118911; | involved 10-year patent-interference proceedings [2] | [1], [2] | |||||||||||||||||||||
Dx | Hearing Loss | GJB2/Connexin 26, GJB6/Connexin 30, SLC26A4/PDS, MTRNR1, and MTTS1 | [1], [2] | ||||||||||||||||||||||||||
Dx | Haemochromatosis | HFE (C282Y, H63D mutations) | Bio-Rad | 86 | 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 | [1], [2] | http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/2242?db=genetests | |||||||||||||||||||||
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, VKORC1 | Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test | [3] | http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm | ||||||||||||||||||||||||
PGx | Sprycel (dasatinib) | BCR-ABL | SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.” | [3] | -ype | disease / drug | genes | patent holder and/or exclusive licensees | Companies offering testing | Number of labs offering testing | license | key patents | product | typical testing cost | notes | report | links | References | |||||||||||
Dx | breast & ovarian cancer | BRCA1, BRCA2 | Myriad Genetics | 1 (Myriad’s CLIA lab) | exclusive | 5753441, 6051379, | BRACAnalysis | $3120 [2] | [1], [2] | http://www.myriad.com/products/bracanalysis.php | [1] CookDeegan:2009p405 | ||||||||||||||||||
Dx | colorectal cancer (HNPCC) | MLH1, MSH2, MSH6 | 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] | [2] SACGHS:2009p1776 | ||||||||||||||||||||
Dx | colorectal cancer (FAP) | APC, MYH | Johns Hopkins | Myriad, Baylor, Harvard, Huntington, University of Pennsylvania, Boston University, Mayo Clinic | 5352775 (APC), | Myriad, MYH: $1795 [2] | [1], [2] | [3] Flockhart:2009p1728 | |||||||||||||||||||||
Dx | Alzheimers | PSEN1, PSEN2, APP (Early Onset AD); APOE | Duke university, Athena Diagnostics | Athena | 1 (Athena); See [2] pg B-23 for list of others? | exclusive | APOE: 5508167, 5716828, 6027896; PSEN1: 6194153; PSEN2: 5840540 | APOE: $475 ($365 for cardiovascular sequencing by St Louis Health Science Center); PSEN1: $1675; PSEN2: $2750 [2] | Cook-Deegan notes “penumbra effect” wrt Athena. Athena sublicensed APOE for DTC testing to Smart Genetics, but First Inventor on patent raised licensing complaints. APOE also is a marker for cardiovascular disease; for which testing would not infringe | [1], [2] | |||||||||||||||||||
Dx | Cystic Fibrosis | CFTR (âF508 most important; 1500 mutations known) | University of Michigan; Hospital for Sick Children in Toronto; Johns Hopkins University | 63 [1] | non-exclusive | 5776677; 5876974; 6984487; 6730777; 7118911; | involved 10-year patent-interference proceedings [2] | [1], [2] | |||||||||||||||||||||
Dx | Hearing Loss | GJB2/Connexin 26, GJB6/Connexin 30, SLC26A4/PDS, MTRNR1, and MTTS1 | [1], [2] | ||||||||||||||||||||||||||
Dx | Haemochromatosis | HFE (C282Y, H63D mutations) | Bio-Rad | 86 | 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 | [1], [2] | http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/2242?db=genetests | |||||||||||||||||||||
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, VKORC1 | Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test | [3] | http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm | ||||||||||||||||||||||||
PGx | Sprycel (dasatinib) | BCR-ABL | SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.” | [3] | http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=11215 | ||||||||||||||||||||||||
OTC | |||||||||||||||||||||||||||||
OTC | |||||||||||||||||||||||||||||
Notes:
- used http://area23.brightbyte.de/csv2wp.php to convert CSV output from Numbers/Excel to wikimarkup
- used http://simile.mit.edu/wiki/Wiki_Table_Editor to edit resulting table