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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] | 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