Diagnostic Kits/Data, narratives and tools produced by the Kits' sector

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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 (∆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?id=11215
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