Diagnostic Kits/Data, narratives and tools produced by the Kits' sector: Difference between revisions

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== colorectal cancer (HNPCC) ==
=== MLH1 ===
Used to diagnose colorectal cancer (HNPCC)


== Alzheimer's ==
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


=== APOE ===
=== APOE ===
Used to diagnose Late Onset Alzheimer's Diseas (LOAD, AD2)
Used to diagnose Late Onset Alzheimer's Disease (LOAD, AD2)
 
http://snpedia.com/index.php/Alzheimer's_disease


At a glance:
At a glance:
Line 76: Line 258:
|APOE
|APOE
|-
|-
|Patent Holders
|Patent Holders & Licensing
|Duke university -> Athena Diagnostics (2 method patents for Dx alzheimer’s, don’t claim sequence, Bilski could destabilize; one claiming a kit) see ref2 pB-6
|Duke university -> Athena Diagnostics
|-
|US Test providers
|Athena Diagnostics* (1)
|-
|-
|Key Patents
|Key Patents
Line 87: Line 272:
|Licenses
|Licenses
|exclusive
|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 ([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)
|-
|Licenses
|exclusive
|-
|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
|-
|Patent Holders & Licensing
|Hospital for Sick Children -> Athena
|-
|US Test providers
|Athena Diagnostics ([http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/53444?db=genetests&report=Full 1])
|-
|Key Patents
|[http://www.google.com/patents/about?id=7pQWAAAAEBAJ&dq=5840540 5840540]
|-
|Other Patents
|5840540
|-
|Licenses
|exclusive
|-
|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
|?
|-
|Other Patents
|
|-
|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]
|-
|Test cost
|[http://www.alz.org/co/documents/2009_Symposium_handout_genetics.pdf $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
==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]
|-
|Test cost
|[http://www.alz.org/co/documents/2009_Symposium_handout_genetics.pdf $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
|US Test providers
|1*
|
|-
|Key Patents
|
|-
|Other Patents
|
|-
|Licenses
|
|-
|-
|Test
|Test
|ADmark® ApoE Genotype Analysis & Interpretation - Symptomatic ($475)
|
|-
|-
|Test cost
|Test cost
|$475
|
|}
 
:*'''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
|[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108967.htm 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'''
:*'''notes'''
*: 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 ref2 pB-8.
:


== template ==
== Sprycel (dasatinib) sensitivity ==
Empty table
=== BCR-ABL ===
Used to predict sensitivity to Sprycel (dasatinib)


snpedia
At a glance:
{|
{|
|-
|-
|Gene
|Gene
|BCR-ABL
|-
|Patent Holders & Licensing
|
|
|-
|-
|Patent Holders
|US Test providers
|
|
|-
|-
Line 119: Line 676:
|-
|-
|Licenses
|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
|US Test providers
|
|-
|Key Patents
|
|-
|Other Patents
|
|-
|Licenses
|
|
|-
|-
Line 131: Line 722:
|}
|}


Definition List
:*'''notes'''
*'''Patent Holders'''
: this is a template entry
*: (exclusive licensee)
* key patents
*: 5753441, 6051379,
* products
*: prod ($3120)


= References =
= References =

Revision as of 12:08, 30 November 2009

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

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

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

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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