Chapter 56 : Molecular Diagnostics and the Changing Legal Landscape

MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Preview this chapter:
Zoom in

Molecular Diagnostics and the Changing Legal Landscape, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555819071/9781555819088.ch56-1.gif /docserver/preview/fulltext/10.1128/9781555819071/9781555819088.ch56-2.gif


Molecular diagnostics is poised to transform health care in the coming decade. The molecular diagnostic industry is quickly evolving because of many factors including success with the companion diagnostic model, the rapid advance of gene sequencing and other detection technologies, the Affordable Care Act, and the Supreme Court's reworking of the boundaries of patentable subject matter. As a result, companies in this space must learn to navigate a quickly evolving industry and drastically changed legal framework if they are to be successful in protecting their innovations and investments.

Citation: Hayman M, Wang J, Libby J. 2016. Molecular Diagnostics and the Changing Legal Landscape, p 803-810. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch56
Highlighted Text: Show | Hide
Loading full text...

Full text loading...


1. Olsen D, Jørgensen JT . 2014. Companion diagnostics for targeted cancer drugs—clinical and regulatory aspects. Front Oncol 4 : 105[CrossRef].[PubMed]
2. Ou SH, Soo RA, Kubo A, Kawaguchi T, Ahn MJ . 2014. Will the requirement by the US FDA to simultaneously co-develop companion diagnostics (CDx) delay the approval of receptor tyrosine kinase inhibitors for RTK-rearranged (ROS1-, RET-, AXL-, PDGFR-α-, NTRK-) non-small cell lung cancer globally? Front Oncol 4 : 58[CrossRef].[PubMed]
3. Pant S, Weiner R, Marton MJ . 2014. Navigating the rapids: the development of regulated next-generation sequencing-based clinical trial assays and companion diagnostics. Front Oncol 4 : 78[CrossRef].[PubMed]
4. Claus EB, Schildkraut JM, Thompson WD, Risch NJ . 1996. The genetic attributable risk of breast and ovarian cancer. Cancer 77 : 2318 2324[CrossRef].[PubMed]
5. Pal T, Permuth-Wey J, Betts JA, Krischer JP, Fiorica J, Arango H, LaPolla J, Hoffman M, Martino MA, Wakeley K, Wilbanks G, Nicosia S, Cantor A, Sutphen R . 2005. BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases. Cancer 104 : 2807 2816[CrossRef].[PubMed]
6. Risch HA, McLaughlin JR, Cole DE, Rosen B, Bradley L, Kwan E, Jack E, Vesprini DJ, Kuperstein G, Abrahamson JL, Fan I, Wong B, Narod SA . 2001. Prevalence and penetrance of germline BRCA1 and BRCA2 mutations in a population series of 649 women with ovarian cancer. Am J Hum Genet 68 : 700 710[CrossRef].[PubMed]
7. Kirschner BS . 1998. Safety of azathioprine and 6-mercaptopurine in pediatric patients with inflammatory bowel disease. Gastroenterology 115 : 813 821[CrossRef].[PubMed]

This is a required field
Please enter a valid email address
Please check the format of the address you have entered.
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error