Diagnostic Kits/Data, narratives and tools produced by the Kits' sector: Difference between revisions
AClearwater (talk | contribs) |
|||
Line 5: | Line 5: | ||
== Breast and Ovarian Cancer == | == 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 | |||
Myriad has not enforced patents for services it does not provide | |||
=== BRCA1 === | === BRCA1 === |
Revision as of 11:44, 3 December 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
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 Myriad has not enforced patents for services it does not provide
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
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 |
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