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=List of Genetic Molecular Diagnostics from the literature=
{{TOCright}}
 
'''NOTE:''' Also see [[Diagnostic_Kits/Commons_based_cases_in_Kits|Commons based cases in Kits]]
 
=Types of inputs for kits=
 
=Genetic Diagnostic Case Studies=
The following are summaries of IP and commercialization information of commercially available diagnostic kits.  A subset of this list will be developed into more extensive case studies.  The old spreadsheet form of this information is available [[Data, narratives and tools produced by the Kits' sector/GeneDxChart|here]].
 
== Breast and Ovarian Cancer ==
 
SACGHS Pipeline:
*Basic and Clinical Research
*Development
*Commercialization
*Communication/Marketing
*Adoption by Clinical Providers and Testing Laboratories
*Adoption by Third-Party Payers
*Consumer Utilization
 
Important Points from the SACGHS review:
*Myriad has not enforced its patents against researchers (SACGHS Appendix 1, A-2)
*Myriad has not enforced patents for services it does not provide (SACGHS Appendix 1, A-4)
*Data shows little price effect of the BRCA patents (SACGHS Appendix 1, A-4)
*"It is therefore difficult to attribute reduced access to BRCA testing to patents.  We cannot exclude the possibility that patent holder’s investments in education about hereditary breast and ovarian cancer (HBOC) and testing have actually had the opposite effect of increasing access to testing" (SACGHS Appendix 1, A-7)
 
 
=== BRCA1 ===
At a glance:
{|
{|
|Type
|-
|disease / drug
|Gene
|genes
|BRCA1
|patent holder and/or exclusive licensees
|-
|Companies offering testing
|Patent Holders
|Number of labs offering testing
|license
|key patents
|product
|typical testing cost
|notes
|report
|links
|References
|
|
|
|----
|Dx
|breast & ovarian cancer
|BRCA1, BRCA2
|Myriad Genetics
|Myriad Genetics
|-
|Key Patents
|5753441, 6051379
|-
|Other Patents
|
|
|1 (Myriad’s CLIA lab)
|-
|Licenses
|exclusive
|exclusive
|5753441, 6051379,
|-
|BRACAnalysis
|US Test providers
|$3120 [2]
|1
|
|-
|[1], [2]
|Test
|http://www.myriad.com/products/bracanalysis.php
|BRACAnalysis ($3120) - includes BRCA1 & BRCA2
|[1] CookDeegan:2009p405
|-
|
|Test cost
|
|$3120
|
|}
|----
 
|Dx
=== BRCA2 ===
|colorectal cancer (HNPCC)
At a glance:
|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,
|Gene
|
|BRCA2
|
|-
|5922855, 5591826 (protein), 5693470
|Patent Holders
|
|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 (∆F508 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?{| |
|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
|Myriad Genetics
|-
|Key Patents
|5753441, 6051379
|-
|Other Patents
|
|
|1 (Myriad’s CLIA lab)
|-
|Licenses
|exclusive
|exclusive
|5753441, 6051379,
|-
|BRACAnalysis
|US Test providers
|$3120 [2]
|1
|
|-
|[1], [2]
|Test
|http://www.myriad.com/products/bracanalysis.php
|BRACAnalysis ($3120) - includes BRCA1 & BRCA2
|[1] CookDeegan:2009p405
|-
|
|Test cost
|
|$3120
|
|}
|----
 
|Dx
== colorectal cancer (HNPCC) ==
|colorectal cancer (HNPCC)
=== MLH1 ===
|MLH1, MSH2, MSH6
Used to diagnose colorectal cancer (HNPCC)
 
snpedia
 
At a glance:
{|
|-
|Gene
|MLH1
|-
|Patent Holders & Licensing
|Oregon Health Sciences University + Dana Farber; Johns Hopkins  
|Oregon Health Sciences University + Dana Farber; Johns Hopkins  
|Baylor, Boston University, City of Hope, Harvard, Huntington, Mayo Clinic, University of Pennsylvania, Quest, Myriad,  
|-
|
|US Test providers
|
|Baylor, Boston University, City of Hope, Harvard, Huntington, Mayo Clinic, University of Pennsylvania, Quest, Myriad, (9)
|-
|Key Patents
|5922855, 5591826 (protein), 5693470
|5922855, 5591826 (protein), 5693470
|-
|Other Patents
|
|
|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.
|Licenses
|[1], [2]
|?
|-
|Test
|
|
|[2] SACGHS:2009p1776
|-
|Test cost
|Myriad, MLH1 + MSH2 + MSH6: $2950; see (ref2 pA-12) for more prices
|}
 
:*'''notes'''
: this is a template entry
 
=== MSH2 ===
Used to diagnose...
 
snpedia
 
At a glance:
{|
|-
|Gene
|
|
|-
|Patent Holders & Licensing
|
|
|-
|US Test providers
|
|
|----
|-
|Dx
|Key Patents
|colorectal cancer (FAP)
|APC, MYH
|Johns Hopkins
|Myriad, Baylor, Harvard, Huntington, University of Pennsylvania, Boston University, Mayo Clinic
|
|
|-
|Other Patents
|
|
|5352775 (APC),
|-
|Licenses
|
|
|Myriad, MYH: $1795 [2]
|-
|Test
|
|
|[1], [2]
|-
|Test cost
|
|
|[3] Flockhart:2009p1728
|}
 
:*'''notes'''
: this is a template entry
 
=== MSH6 ===
Used to diagnose...
 
snpedia
 
At a glance:
{|
|-
|Gene
|
|
|-
|Patent Holders & Licensing
|
|
|-
|US Test providers
|
|
|----
|-
|Dx
|Key Patents
|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
|Other Patents
|[1], [2]
|
|
|-
|Licenses
|
|
|-
|Test
|
|
|-
|Test cost
|
|
|}
:*'''notes'''
: this is a template entry
== colorectal cancer (FAP) ==
=== APC ===
Used to diagnose...
snpedia
At a glance:
{|
|-
|Gene
|
|
|----
|-
|Dx
|Patent Holders & Licensing
|Cystic Fibrosis
|CFTR (∆F508 most important; 1500 mutations known)
|
|
|University of Michigan; Hospital for Sick Children in Toronto; Johns Hopkins University
|-
|63 [1]
|US Test providers
|non-exclusive
|5776677; 5876974; 6984487; 6730777; 7118911;
|
|
|-
|Key Patents
|
|
|involved 10-year patent-interference proceedings [2]
|-
|[1], [2]
|Other Patents
|
|
|-
|Licenses
|
|
|-
|Test
|
|
|-
|Test cost
|
|
|}
:*'''notes'''
: this is a template entry
=== MYH ===
Used to diagnose...
snpedia
At a glance:
{|
|-
|Gene
|
|
|----
|-
|Dx
|Patent Holders & Licensing
|Hearing Loss
|GJB2/Connexin 26, GJB6/Connexin 30, SLC26A4/PDS, MTRNR1, and MTTS1
|
|
|-
|US Test providers
|
|
|-
|Key Patents
|
|
|-
|Other Patents
|
|
|-
|Licenses
|
|
|-
|Test
|
|
|-
|Test cost
|
|
|}
:*'''notes'''
: this is a template entry
==Alzheimer's Disease==
Important Points from the SACGHS review:
(Keep in mind that in this case study this is Duke writing about some of their own patents)
*"An argument can be made that patents were part of the mix of motivations that spurred innovation in Alzheimer’s research." (SACGHS Appendix 1, B-14)
*"At least in the initial period of discovery, the patenting landscape encouraged research, or at least did not dramatically hinder it." (SACGHS Appendix 1, B-14)
*Athena Diagnostics controls the testing market in this area due to patents.  The positive and negative effects of this are not clear. (SACGHS Appendix 1, B-15) 
* Palombi presents anecdotal evidence that a patent thicket is forming around Alzheimer's research and preventing commercialization of diagnostics and treatments ([[Diagnostic Kits/The Search for Alternatives to Patents in the 21st Century|Palombi p.25]]).
=== APOE ===
Used to diagnose Late Onset Alzheimer's Disease (LOAD, AD2)
http://snpedia.com/index.php/Alzheimer's_disease
At a glance:
{|
|-
|Gene
|APOE
|-
|Patent Holders & Licensing
|Duke university -> Athena Diagnostics
|-
|US Test providers
|Athena Diagnostics* (1)
|-
|Key Patents
|5508167, 5716828, 6027896
|-
|Other Patents
|
|
|[1], [2]
|-
|
|Licenses
|
|
|
|
|----
|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
|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?|-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
|
|
|
|-
|-
|Test
|ADmark® ApoE Genotype Analysis & Interpretation - Symptomatic
|-
|Test cost
|$475
|}
*'''patent details'''
*: 2 method patents for Diagnosing Alzheimer’s that don’t claim sequence; Bilski outcome could destabilize. One patent claims a kit. see ref2 pB-6 for more details.
*'''effects of patents'''
*: Cook-Deegan notes “penumbra effect” with regard to Athena Diagnosics. Athena sublicensed APOE for Direct-to-consumer (DTC) testing to Smart Genetics, but the first inventor on the patent raised licensing complaints for ethical reasons (ref2 pB-16).  APOE also is a marker for cardiovascular disease; testing for which does not infringe the methods patents, see ref2 pB-8. Also 2 testing labs in Canada, McGill and Sunnybrook both offer APOE testing for AD for $100 & $120 respectively ref2 pB-8.
=== PSEN1 ===
Used to diagnose early-onset Alzheimer's Disease (EOAD, AD3)
snpedia
At a glance:
{|
|-
|Gene
|PSEN1
|-
|Patent Holders & Licensing
|Hospital for Sick Children, U Toronto -> Athena
|-
|US Test providers
|Athena Diagnostics ([http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/53441?db=genetests&report=Full 1])
|-
|Key Patents
|[http://www.google.com/patents/about?id=5agFAAAAEBAJ&dq=6194153 6194153]
|-
|Other Patents
|5986054, 6531586, 6248555 (dropped)
|-
|-
|Dx
|Licenses
|breast & ovarian cancer
|BRCA1, BRCA2
|Myriad Genetics
|
|1 (Myriad’s CLIA lab)
|exclusive
|exclusive
|5753441, 6051379,
|BRACAnalysis
|$3120 [2]
|
|[1], [2]
|http://www.myriad.com/products/bracanalysis.php
|[1] CookDeegan:2009p405
|
|
|
|-
|-
|Test
|[http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1261 ADmark® PS-1 DNA Sequencing Test]
|-
|Test cost
|$1675 (ref2 pB-15)
|}
=== PSEN2 ===
Used to diagnose early-onset Alzheimer's Disease (EOAD, AD4)
snpedia
At a glance:
{|
|-
|Gene
|PSEN2
|-
|-
|Dx
|Patent Holders & Licensing
|colorectal cancer (HNPCC)
|Hospital for Sick Children -> Athena
|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
|
|
|
|-
|-
|US Test providers
|Athena Diagnostics ([http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/53444?db=genetests&report=Full 1])
|-
|-
|Dx
|Key Patents
|colorectal cancer (FAP)
|[http://www.google.com/patents/about?id=7pQWAAAAEBAJ&dq=5840540 5840540]
|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
|
|
|
|-
|-
|Other Patents
|5840540
|-
|-
|Dx
|Licenses
|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
|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]
|
|
|
|
|
|-
|-
|Test
|[http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1259 ADmark® PS-2 DNA Sequencing Test]
|-
|Test cost
|[http://www.alz.org/co/documents/2009_Symposium_handout_genetics.pdf $1500]?
|}
===APP===
Used to diagnose early-onset Alzheimer's Disease (EOAD, AD1)
snpedia
At a glance:
{|
|-
|Gene
|APP
|-
|Patent Holders & Licensing
|Hospital for Sick Children -> Athena
|-
|US Test providers
|Athena Diagnostics, Signature Genomics ([http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/53438?db=genetests&report=Full 2])
|-
|Key Patents
|?
|-
|-
|Dx
|Other Patents
|Cystic Fibrosis
|CFTR (∆F508 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]
|
|
|
|
|
|
|-
|-
|Licenses
|?
|-
|Test
|[http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1260 ADmark® APP DNA Sequencing/Duplication Test]; [http://www.signaturegenomics.com/signaturefish.html SignatureFISH]
|-
|-
|Dx
|Test cost
|Hearing Loss
|[http://www.alz.org/co/documents/2009_Symposium_handout_genetics.pdf $1500]?
|GJB2/Connexin 26, GJB6/Connexin 30, SLC26A4/PDS, MTRNR1, and MTTS1
|}
|
 
|
:*'''notes'''
|
: Signature genomics provides a FISH-based test for APP; only Athena does complete sequencing
|
 
|
== Haemochromatosis ==
|
=== HFE ===
|
Used to diagnose Haemochromatosis
|
 
|[1], [2]
snpedia
|
 
|
At a glance:
|
{|
|
|
|-
|-
|Gene
|HFE
|-
|-
|Dx
|Patent Holders & Licensing
|Haemochromatosis
|HFE (C282Y, H63D mutations)
|Bio-Rad
|Bio-Rad
|86
|-
|
|US Test providers
|
|
|-
|Key Patents
|?
|-
|Other Patents
|
|
|-
|Licenses
|?
|-
|Test
|mDx Hereditary Hemochromatosis ASR kit; mDx Hereditary Hemochromatosis LLA ASR
|mDx Hereditary Hemochromatosis ASR kit; mDx Hereditary Hemochromatosis LLA ASR
|-
|Test cost
|
|
|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
:*'''notes'''
|
: Merz JF, Kriss AG, Leonard DGB, Cho MK. Op. cit. Examine licensing activities around HFE and impact on diagnostic prices (Merz, J.F. et al., 2002. Diagnostic testing fails the test. Nature, 415(6872), 577-579.(Garcia & Shimizu 1997) Available at: http://repository.upenn.edu/bioethics_papers/48/ [Accessed August 5, 2009].)
|
:"Patents exist on the HFE gene, its related protein, genetic screening test methods, and related testing kits." (E-2)
|
:"HFE patents do not appear to have blocked commercial development of additional methods of HFE testing utilizing different platform technologies."(E-4)
|
 
==Cystic Fibrosis==
===CFTR===
Used to diagnose Cystic Fibrosis
 
snpedia
 
At a glance:
{|
|-
|Gene
|CFTR
|-
|Patent Holders & Licensing
|University of Michigan, Hospital for Sick Children
|-
|US Test providers
|Many ([http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/2220?db=genetests 112])
|-
|Key Patents
|[http://www.google.com/patents/about?id=rOsiAAAAEBAJ&dq=5776677 5776677]
|-
|Other Patents
|5876974, 7118911, 6984487, 6730777, 5407796
|-
|Licenses
|non-exclusive
|-
|-
|Test
|[http://www.athenadiagnostics.com/content/test-catalog/find-test/service-detail/q/id/1260 ADmark® APP DNA Sequencing/Duplication Test]; [http://www.signaturegenomics.com/signaturefish.html SignatureFISH]
|-
|-
|Dx
|Test cost
|Long-QT syndrome
|[http://www.alz.org/co/documents/2009_Symposium_handout_genetics.pdf $1500]?
|
|}
|PGxHealth; Bio-Reference Laboratories
 
|
:*'''notes'''
|
: Johns Hopkins also has some key CFTR patents.
|
: The licensing of Cystic Fibrosis IP has been non-exclusive and broad and has resulted in a myriad variety of diagnostics. (or is the demand for CF Dx greater than other diseases?)
|
 
|
 
|
== Spinocerebellar Ataxia ==
|
=== gene ===
|[1], [2]
Used to diagnose Spinocerebellar Ataxia.
|
 
|
snpedia
|
 
|
At a glance:
{|
|-
|Gene
|
|
|-
|-
|Patent Holders & Licensing
|Athena Diagnostics
|-
|-
|Dx
|US Test providers
|Spinocerebellar Ataxia
|
|
|Athena Diagnostics
|-
|Key Patents
|
|
|-
|Other Patents
|
|
|-
|Licenses
|exclusive
|exclusive
|-
|Test
|
|
|-
|Test cost
|
|
|}
:*'''notes'''
:
== Tay-Sachs Disease ==
=== gene ===
Used to diagnose Tay-Sachs Disease.
snpedia
At a glance:
{|
|-
|Gene
|
|
|Cook-Deegan notes “penumbra effect” wrt Athena
|-
|[1], [2]
|Patent Holders & Licensing
|
|
|-
|US Test providers
|
|
|-
|Key Patents
|
|
|-
|Other Patents
|
|
|-
|Licenses
|
|
|-
|-
|Test
|
|-
|-
|Dx
|Test cost
|Tay-Sachs Disease
|
|
|}
:*'''notes'''
:
== Canavan Disease ==
=== gene ===
Used to diagnose Canavan Disease.
snpedia
At a glance:
{|
|-
|Gene
|
|
|-
|Patent Holders & Licensing
|
|
|-
|US Test providers
|
|
|-
|Key Patents
|
|
|-
|Other Patents
|
|
|-
|Licenses
|
|
|-
|Test
|
|
|-
|Test cost
|
|
|[1], [2]
|}
 
:*'''notes'''
:
 
== Coumadin (Warfarin) sensitivity ==
=== CYP2C9 ===
Used to predict sensitivity to Coumadin (Warfarin).
 
snpedia
 
At a glance:
{|
|-
|Gene
|CYP2C9
|-
|Patent Holders & Licensing
|
|
|-
|US Test providers
|
|
|-
|Key Patents
|
|
|-
|Other Patents
|
|
|-
|Licenses
|
|
|-
|-
|Test
|[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test]
|-
|-
|Dx
|Test cost
|Canavan Disease
|
|
|
|
|
|
|
|
|
|[1], [2]
|
|
|
|
|
|
|}
:*'''notes'''
:
=== VKORC1 ===
Used to predict sensitivity to Coumadin (Warfarin).
snpedia
At a glance:
{|
|-
|-
|Gene
|VKORC1
|-
|-
|PGx
|Patent Holders & Licensing
|Coumadin (Warfarin)
|CYP2C9, VKORC1
|
|
|-
|US Test providers
|
|
|-
|Key Patents
|
|
|-
|Other Patents
|
|
|-
|Licenses
|
|
|Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test
|-
|
|Test
|
|[3]
|http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm
|
|
|
|
|-
|Test cost
|
|
|}
:*'''notes'''
:
== Sprycel (dasatinib) sensitivity ==
=== BCR-ABL ===
Used to predict sensitivity to Sprycel (dasatinib)
snpedia
At a glance:
{|
|-
|-
|Gene
|BCR-ABL
|-
|-
|PGx
|Patent Holders & Licensing
|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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|----
|
|
|
|
|-
|US Test providers
|
|
|-
|Key Patents
|
|
|-
|Other Patents
|
|
|-
|Licenses
|
|
|-
|Test
|
|
|-
|Test cost
|
|
|}
:*'''notes'''
:http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=11215
== disease ==
=== gene ===
Used to diagnose...
snpedia
At a glance:
{|
|-
|Gene
|
|
|-
|Patent Holders & Licensing
|
|
|-
|US Test providers
|
|
|-
|Key Patents
|
|
|-
|Other Patents
|
|
|-
|Licenses
|
|
|-
|Test
|
|
|-
|Test cost
|
|
|}
|}


Notes:
:*'''notes'''
* used http://area23.brightbyte.de/csv2wp.php to convert CSV output from Numbers/Excel to wikimarkup
: this is a template entry
* used http://simile.mit.edu/wiki/Wiki_Table_Editor to edit resulting table
 
= References =
 
 
 


=Types of inputs for kits=
=Navigation=
[[Category:Diagnostic_Kits]]
[[Category:Diagnostic_Kits]]
[[Main Page]]
[[Main Page]]
[[Diagnostic_Kits]]
[[Diagnostic_Kits]]

Latest revision as of 17:56, 17 April 2010

NOTE: Also see Commons based cases in Kits

Types of inputs for kits

Genetic Diagnostic Case Studies

The following are summaries of IP and commercialization information of commercially available diagnostic kits. A subset of this list will be developed into more extensive case studies. The old spreadsheet form of this information is available here.

Breast and Ovarian Cancer

SACGHS Pipeline:

  • Basic and Clinical Research
  • Development
  • Commercialization
  • Communication/Marketing
  • Adoption by Clinical Providers and Testing Laboratories
  • Adoption by Third-Party Payers
  • Consumer Utilization

Important Points from the SACGHS review:

  • Myriad has not enforced its patents against researchers (SACGHS Appendix 1, A-2)
  • Myriad has not enforced patents for services it does not provide (SACGHS Appendix 1, A-4)
  • Data shows little price effect of the BRCA patents (SACGHS Appendix 1, A-4)
  • "It is therefore difficult to attribute reduced access to BRCA testing to patents. We cannot exclude the possibility that patent holder’s investments in education about hereditary breast and ovarian cancer (HBOC) and testing have actually had the opposite effect of increasing access to testing" (SACGHS Appendix 1, A-7)


BRCA1

At a glance:

Gene BRCA1
Patent Holders Myriad Genetics
Key Patents 5753441, 6051379
Other Patents
Licenses exclusive
US Test providers 1
Test BRACAnalysis ($3120) - includes BRCA1 & BRCA2
Test cost $3120

BRCA2

At a glance:

Gene BRCA2
Patent Holders Myriad Genetics
Key Patents 5753441, 6051379
Other Patents
Licenses exclusive
US Test providers 1
Test BRACAnalysis ($3120) - includes BRCA1 & BRCA2
Test cost $3120

colorectal cancer (HNPCC)

MLH1

Used to diagnose colorectal cancer (HNPCC)

snpedia

At a glance:

Gene MLH1
Patent Holders & Licensing Oregon Health Sciences University + Dana Farber; Johns Hopkins
US Test providers Baylor, Boston University, City of Hope, Harvard, Huntington, Mayo Clinic, University of Pennsylvania, Quest, Myriad, (9)
Key Patents 5922855, 5591826 (protein), 5693470
Other Patents
Licenses ?
Test
Test cost Myriad, MLH1 + MSH2 + MSH6: $2950; see (ref2 pA-12) for more prices
  • notes
this is a template entry

MSH2

Used to diagnose...

snpedia

At a glance:

Gene
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes
this is a template entry

MSH6

Used to diagnose...

snpedia

At a glance:

Gene
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes
this is a template entry


colorectal cancer (FAP)

APC

Used to diagnose...

snpedia

At a glance:

Gene
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes
this is a template entry

MYH

Used to diagnose...

snpedia

At a glance:

Gene
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes
this is a template entry

Alzheimer's Disease

Important Points from the SACGHS review: (Keep in mind that in this case study this is Duke writing about some of their own patents)

  • "An argument can be made that patents were part of the mix of motivations that spurred innovation in Alzheimer’s research." (SACGHS Appendix 1, B-14)
  • "At least in the initial period of discovery, the patenting landscape encouraged research, or at least did not dramatically hinder it." (SACGHS Appendix 1, B-14)
  • Athena Diagnostics controls the testing market in this area due to patents. The positive and negative effects of this are not clear. (SACGHS Appendix 1, B-15)
  • Palombi presents anecdotal evidence that a patent thicket is forming around Alzheimer's research and preventing commercialization of diagnostics and treatments (Palombi p.25).

APOE

Used to diagnose Late Onset Alzheimer's Disease (LOAD, AD2)

http://snpedia.com/index.php/Alzheimer's_disease

At a glance:

Gene APOE
Patent Holders & Licensing Duke university -> Athena Diagnostics
US Test providers Athena Diagnostics* (1)
Key Patents 5508167, 5716828, 6027896
Other Patents
Licenses exclusive
Test ADmark® ApoE Genotype Analysis & Interpretation - Symptomatic
Test cost $475
  • patent details
    2 method patents for Diagnosing Alzheimer’s that don’t claim sequence; Bilski outcome could destabilize. One patent claims a kit. see ref2 pB-6 for more details.
  • effects of patents
    Cook-Deegan notes “penumbra effect” with regard to Athena Diagnosics. Athena sublicensed APOE for Direct-to-consumer (DTC) testing to Smart Genetics, but the first inventor on the patent raised licensing complaints for ethical reasons (ref2 pB-16). APOE also is a marker for cardiovascular disease; testing for which does not infringe the methods patents, see ref2 pB-8. Also 2 testing labs in Canada, McGill and Sunnybrook both offer APOE testing for AD for $100 & $120 respectively ref2 pB-8.

PSEN1

Used to diagnose early-onset Alzheimer's Disease (EOAD, AD3)

snpedia

At a glance:

Gene PSEN1
Patent Holders & Licensing Hospital for Sick Children, U Toronto -> Athena
US Test providers Athena Diagnostics (1)
Key Patents 6194153
Other Patents 5986054, 6531586, 6248555 (dropped)
Licenses exclusive
Test ADmark® PS-1 DNA Sequencing Test
Test cost $1675 (ref2 pB-15)


PSEN2

Used to diagnose early-onset Alzheimer's Disease (EOAD, AD4)

snpedia

At a glance:

Gene PSEN2
Patent Holders & Licensing Hospital for Sick Children -> Athena
US Test providers Athena Diagnostics (1)
Key Patents 5840540
Other Patents 5840540
Licenses exclusive
Test ADmark® PS-2 DNA Sequencing Test
Test cost $1500?


APP

Used to diagnose early-onset Alzheimer's Disease (EOAD, AD1)

snpedia

At a glance:

Gene APP
Patent Holders & Licensing Hospital for Sick Children -> Athena
US Test providers Athena Diagnostics, Signature Genomics (2)
Key Patents ?
Other Patents
Licenses ?
Test ADmark® APP DNA Sequencing/Duplication Test; SignatureFISH
Test cost $1500?
  • notes
Signature genomics provides a FISH-based test for APP; only Athena does complete sequencing

Haemochromatosis

HFE

Used to diagnose Haemochromatosis

snpedia

At a glance:

Gene HFE
Patent Holders & Licensing Bio-Rad
US Test providers
Key Patents ?
Other Patents
Licenses ?
Test mDx Hereditary Hemochromatosis ASR kit; mDx Hereditary Hemochromatosis LLA ASR
Test cost
  • notes
Merz JF, Kriss AG, Leonard DGB, Cho MK. Op. cit. Examine licensing activities around HFE and impact on diagnostic prices (Merz, J.F. et al., 2002. Diagnostic testing fails the test. Nature, 415(6872), 577-579.(Garcia & Shimizu 1997) Available at: http://repository.upenn.edu/bioethics_papers/48/ [Accessed August 5, 2009].)
"Patents exist on the HFE gene, its related protein, genetic screening test methods, and related testing kits." (E-2)
"HFE patents do not appear to have blocked commercial development of additional methods of HFE testing utilizing different platform technologies."(E-4)

Cystic Fibrosis

CFTR

Used to diagnose Cystic Fibrosis

snpedia

At a glance:

Gene CFTR
Patent Holders & Licensing University of Michigan, Hospital for Sick Children
US Test providers Many (112)
Key Patents 5776677
Other Patents 5876974, 7118911, 6984487, 6730777, 5407796
Licenses non-exclusive
Test ADmark® APP DNA Sequencing/Duplication Test; SignatureFISH
Test cost $1500?
  • notes
Johns Hopkins also has some key CFTR patents.
The licensing of Cystic Fibrosis IP has been non-exclusive and broad and has resulted in a myriad variety of diagnostics. (or is the demand for CF Dx greater than other diseases?)


Spinocerebellar Ataxia

gene

Used to diagnose Spinocerebellar Ataxia.

snpedia

At a glance:

Gene
Patent Holders & Licensing Athena Diagnostics
US Test providers
Key Patents
Other Patents
Licenses exclusive
Test
Test cost
  • notes

Tay-Sachs Disease

gene

Used to diagnose Tay-Sachs Disease.

snpedia

At a glance:

Gene
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes

Canavan Disease

gene

Used to diagnose Canavan Disease.

snpedia

At a glance:

Gene
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes

Coumadin (Warfarin) sensitivity

CYP2C9

Used to predict sensitivity to Coumadin (Warfarin).

snpedia

At a glance:

Gene CYP2C9
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test
Test cost
  • notes

VKORC1

Used to predict sensitivity to Coumadin (Warfarin).

snpedia

At a glance:

Gene VKORC1
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes

Sprycel (dasatinib) sensitivity

BCR-ABL

Used to predict sensitivity to Sprycel (dasatinib)

snpedia

At a glance:

Gene BCR-ABL
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=11215

disease

gene

Used to diagnose...

snpedia

At a glance:

Gene
Patent Holders & Licensing
US Test providers
Key Patents
Other Patents
Licenses
Test
Test cost
  • notes
this is a template entry

References

Main Page Diagnostic_Kits

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