Diagnostic Kits - Revision history

WikiSysop: /* Legal Aspects of Diagnostics */

2010-10-16T21:15:50Z

Legal Aspects of Diagnostics

← Older revision		Revision as of 21:15, 16 October 2010
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	==Legal Aspects of Diagnostics==		==Legal Aspects of Diagnostics==
	===[[Diagnostic Kits/Case Law Review\|Case Law Review]]===		===[[Diagnostic Kits/Case Law Review\|Case Law Review]]===
	~~===[[Diagnostic Kits/Literature Review\|Literature Review]]===~~
	===[[Diagnostic Kits/Country Reports Review\|Country Reports Review]]===		===[[Diagnostic Kits/Country Reports Review\|Country Reports Review]]===
	===[[Diagnostic Kits/USA Regulation Review\|USA Regulation Review]]===		===[[Diagnostic Kits/USA Regulation Review\|USA Regulation Review]]===

DavidO: /* Laboratories */

2010-07-02T18:31:25Z

Laboratories

← Older revision		Revision as of 18:31, 2 July 2010
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	* [http://en.wikipedia.org/wiki/List_of_genetics_research_organizations Wikipedia's List of Genetics Research Organizations]		* [http://en.wikipedia.org/wiki/List_of_genetics_research_organizations Wikipedia's List of Genetics Research Organizations]

	~~===Laboratories===~~
	* [http://en.wikipedia.org/wiki/Quest_Diagnostics Quest] (wikipedia) [http://www.wikinvest.com/stock/Quest_Diagnostics_(DGX) DGX] stock symbol. (SEC CIK#: [http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001022079&owner=include&count=40 0001022079] )
	** [http://www.sec.gov/Archives/edgar/data/1022079/000093041309000848/c56618_10-k.htm 2008 10-K - Annual Report]
	*** Net Sales of gene-based & esoteric tests: $1,400 Million (20% of total revenue).

	* [http://en.wikipedia.org/wiki/LabCorp LabCorp] wikipedia. [http://www.wikinvest.com/stock/Laboratory_Corporation_of_America_Holdings_%28LH%29?ref=topnav LH] stock symbol. (SEC CIK# [http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000920148&owner=include&count=40 0000920148])
	** [http://www.sec.gov/Archives/edgar/data/920148/000092014809000015/labcorp10k.htm 2008 10-K - Annual Report]
	*** Net Sales of Genomic & Esoteric tests: $1,478.3 Million (+5.9% from 2007)
	*** Volume of Genomic & Esoteric tests: 23.7 Million
	*** Patents, licences, and technology "2008 gross carrying amount": 94.7 million

	* Bio-Reference Laboratories INC (SEC CIK# [http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000792641&owner=include&count=40 0000792641])
	** [http://www.sec.gov/Archives/edgar/data/792641/000110465909002204/a09-3066_110k.htm 2008 10-K - Annual Report]
	*** Net revenue from esoteric tests (50%): $150.5 Million

	* Athena Diagnostics INC (SEC CIK# [http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001161704&owner=include&count=40 0001161704])

	==Legal Aspects of Diagnostics==		==Legal Aspects of Diagnostics==

DavidO: /* DTC and Clinical Genetic Testing Manufacturers and Service Providers */

2010-07-02T18:26:52Z

DTC and Clinical Genetic Testing Manufacturers and Service Providers

← Older revision		Revision as of 18:26, 2 July 2010
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	* [http://www.dnatribes.com/ DNA Tribes]		* [http://www.dnatribes.com/ DNA Tribes]
	* [http://www.bioresolve.com/ Bio Resolve]		* [http://www.bioresolve.com/ Bio Resolve]
			* [http://www.myriad.com Myriad Genetics]
			* [http://www.responsegenetics.com/ Response Genetics]
			* [http://www.ilgenetics.com/ Interleukin Genetics]
			* [http://www.exactsciences.com/ Exact Sciences]
			* [http://www.genomichealth.com/ Genomic Health]
			* [http://www.nanosphere.us/ Nanosphere]
			* [http://en.wikipedia.org/wiki/List_of_genetics_research_organizations Wikipedia's List of Genetics Research Organizations]

	===Laboratories===		===Laboratories===

DavidO: /* Laboratories */

2010-07-02T18:15:59Z

Laboratories

← Older revision		Revision as of 18:15, 2 July 2010
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	===Laboratories===		===Laboratories===
	"The major national reference labs including Quest, LabCorp, Specialty/Ameripath, Mayo and others account for at least 60% of the market for esoteric test services. The remaining 40% is shared by a group of some 3000 small, local market laboratories. The major reference labs have built a comprehensive menu of specialized test services and continue to expand their offerings via collaborations with leading medical research centers. They offer a huge presence in the market and manage distribution networks that touch just about every medical specialty. Thus many CLIA-registered company sponsored test services avail themselves of the marketing resources offered by the national reference labs."

	Quest and Labcorp are the two most dominant national reference labs. Financial information can be gotten from the SEC by using the ''Standard Industrial Classification'' [http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&SIC=8071 8071: Services - medical laboratories], which includes Quest, Lab-Corp, Bio-Reference, Athena, and ~120 others.

	* [http://en.wikipedia.org/wiki/Quest_Diagnostics Quest] (wikipedia) [http://www.wikinvest.com/stock/Quest_Diagnostics_(DGX) DGX] stock symbol. (SEC CIK#: [http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001022079&owner=include&count=40 0001022079] )		* [http://en.wikipedia.org/wiki/Quest_Diagnostics Quest] (wikipedia) [http://www.wikinvest.com/stock/Quest_Diagnostics_(DGX) DGX] stock symbol. (SEC CIK#: [http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001022079&owner=include&count=40 0001022079] )
	** [http://www.sec.gov/Archives/edgar/data/1022079/000093041309000848/c56618_10-k.htm 2008 10-K - Annual Report]		** [http://www.sec.gov/Archives/edgar/data/1022079/000093041309000848/c56618_10-k.htm 2008 10-K - Annual Report]

DavidO: /* DTC and Clinical Genetic Testing Manufacturers and Service Providers */

2010-07-02T18:13:22Z

DTC and Clinical Genetic Testing Manufacturers and Service Providers

← Older revision		Revision as of 18:13, 2 July 2010
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	===DTC and Clinical Genetic Testing Manufacturers and Service Providers===		===DTC and Clinical Genetic Testing Manufacturers and Service Providers===
	* [http://cpmc.coriell.org/ ~~cpmc.coriell.org~~]: Free Affymetrix GeneChip SNP sequencing, but only for "potentially medically actionable" conditions. Currently this list includes 10 conditions, and will grow as the Informed Cohort Oversight Board approves more conditions.		* [http://cpmc.coriell.org/ Coriell Personalized Medicine Collaboration]
	* [http://www.23andme.com/ 23 and Me]		* [http://www.23andme.com/ 23 and Me]
	* [http://www.decodeme.com/ DeCODEme~~.com~~]~~: $195 - $985 for up to 48 genetic conditions using a 100,000 SNP chip. In Bankruptcy proceedings.~~		* [http://www.decodeme.com/ DeCODEme]
	* [http://www.counsyl.com/ Counsyl~~.com~~]: offers a (I presume) a chip-based screen for 100 genetic disease markers, including some for cystic fibrosis. Trying to sell both direct to consumers and clinically and aiming for insurance coverage. DTC costs $349. Not sure how they ensure the results are clinically useful.		* [http://www.counsyl.com/ Counsyl]
	* [http://www.navigenics.com/ Navigenics~~.com~~]~~: offers chip-based testing for 28 different conditions along with personal genetic counseling for $999. Not sure how they ensure the results are clinically useful. Want to be clinically used.~~		* [http://www.navigenics.com/ Navigenics]
	* [http://www.pathway.com/ ~~PathwayGenomics.com~~]~~: offers carrier testing for 61 genetic diseases, metabolism genes for 9 different drugs, as well as ancestry analysis for $199-$399. Not sure how they ensure the results are clinically useful.~~		* [http://www.pathway.com/ Pathway Genomics]
	* [http://www.dnadirect.com/web/ ~~DNADirect.com~~] ~~- not sure what their product is.~~		* [http://www.dnadirect.com/web/ DNA Direct]
	* [http://genomichealth.com/ ~~GenomicHealth.com~~] / [http://~~oncotypedx~~.com/ ~~OncotypeDX.com~~] : ~~21-gene expression assay that predicts recurrence of certain kinds of breast cancer~~. Considered a multivariate assay and regulated by the FDA; has more clinical data than most other genetic diagnostics demonstrating it's clinical validity and utility. Covered my insurance more often than other tests.		* [http://genomichealth.com/ Genomic Health]
			* [http://www.dnatribes.com/ DNA Tribes]
			* [http://www.bioresolve.com/ Bio Resolve]

	===Laboratories===		===Laboratories===

DavidO: /* Recreational and Clinical Genetic Testing Manufacturers and Service Providers */

2010-07-02T18:03:49Z

Recreational and Clinical Genetic Testing Manufacturers and Service Providers

← Older revision		Revision as of 18:03, 2 July 2010
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	* [http://www.personalgenomes.org/ Personal Genome Project]		* [http://www.personalgenomes.org/ Personal Genome Project]

	=== ~~Recreational~~ and Clinical Genetic Testing Manufacturers and Service Providers===		===DTC and Clinical Genetic Testing Manufacturers and Service Providers===
	* [http://cpmc.coriell.org/ cpmc.coriell.org]: Free Affymetrix GeneChip SNP sequencing, but only for "potentially medically actionable" conditions. Currently this list includes 10 conditions, and will grow as the Informed Cohort Oversight Board approves more conditions.		* [http://cpmc.coriell.org/ cpmc.coriell.org]: Free Affymetrix GeneChip SNP sequencing, but only for "potentially medically actionable" conditions. Currently this list includes 10 conditions, and will grow as the Informed Cohort Oversight Board approves more conditions.
	* [http://www.23andme.com/ 23 and Me]		* [http://www.23andme.com/ 23 and Me]

DavidO: /* Clinical Diagnostics Testing Purposes */

2010-07-01T21:24:41Z

Clinical Diagnostics Testing Purposes

← Older revision		Revision as of 21:24, 1 July 2010
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	<br/>		<br/>

	===Clinical ~~Diagnostics~~ Testing Purposes===		===Clinical Testing Purposes===
	The largest category of diagnostic tests are used for clinical applications - i.e., in the course of treatment or diagnosis of diseases, and in the course of preventative medical care. In most circumstances, these tests are ordered by medical professionals. The following table illustrates the range testing purposes.		The largest category of diagnostic tests are used for clinical applications - i.e., in the course of treatment or diagnosis of diseases, and in the course of preventative medical care. In most circumstances, these tests are ordered by medical professionals. The following table illustrates the range testing purposes.
	<br/><br/>		<br/><br/>

DavidO: /* Distinctions Between Genetics and Genomics Terminology */

2010-07-01T21:24:18Z

Distinctions Between Genetics and Genomics Terminology

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	The difference between these terms is scientifically important because they refer to distinct concepts. These terms are often confused because the distinctions between "genetic" and "genomic" diagnostics are rarely delineated well, if at all. Consequently, discussions of their market, innovation cycles and the impact of intellectual property in the emergence of open or closed arrangements of cooperation is less than precise.		The difference between these terms is scientifically important because they refer to distinct concepts. These terms are often confused because the distinctions between "genetic" and "genomic" diagnostics are rarely delineated well, if at all. Consequently, discussions of their market, innovation cycles and the impact of intellectual property in the emergence of open or closed arrangements of cooperation is less than precise.

	===Distinctions Between Genetics and Genomics ~~Terminology~~===		===The Distinctions Between Genetics and Genomics===
	In simple terms, "Genetics" can be defined as the scientific study of single genes and their effects. Genes are units of heredity that carry the instructions for making proteins, which direct the activities of cells and functions of the body. Genetics is also term that refers to the study of genes and their role in inheritance - the way certain traits or conditions are passed down from one generation to another. Genes influence traits such as hair and eye color as well as health and disease development. Genetics determines much, but not all, of a person's appearance and health status. Environmental factors also play a part. Many disorders of the human body, such as disease and illness, are linked to abnormal gene function. For example, single gene disorders include cystic fibrosis and PKU (phenylketonuria). For more examples, see [http://www.Genome.gov National Human Genome Research Institute] and [http://www.CDC.gov The Centers for Disease Control and Prevention].		In simple terms, "Genetics" can be defined as the scientific study of single genes and their effects. Genes are units of heredity that carry the instructions for making proteins, which direct the activities of cells and functions of the body. Genetics is also term that refers to the study of genes and their role in inheritance - the way certain traits or conditions are passed down from one generation to another. Genes influence traits such as hair and eye color as well as health and disease development. Genetics determines much, but not all, of a person's appearance and health status. Environmental factors also play a part. Many disorders of the human body, such as disease and illness, are linked to abnormal gene function. For example, single gene disorders include cystic fibrosis and PKU (phenylketonuria). For more examples, see [http://www.Genome.gov National Human Genome Research Institute] and [http://www.CDC.gov The Centers for Disease Control and Prevention].

DavidO: /* Reference labs */

2010-07-01T21:22:17Z

Reference labs

← Older revision		Revision as of 21:22, 1 July 2010
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	* [http://genomichealth.com/ GenomicHealth.com] / [http://oncotypedx.com/ OncotypeDX.com] : 21-gene expression assay that predicts recurrence of certain kinds of breast cancer. Considered a multivariate assay and regulated by the FDA; has more clinical data than most other genetic diagnostics demonstrating it's clinical validity and utility. Covered my insurance more often than other tests.		* [http://genomichealth.com/ GenomicHealth.com] / [http://oncotypedx.com/ OncotypeDX.com] : 21-gene expression assay that predicts recurrence of certain kinds of breast cancer. Considered a multivariate assay and regulated by the FDA; has more clinical data than most other genetic diagnostics demonstrating it's clinical validity and utility. Covered my insurance more often than other tests.

	===~~= Reference labs =~~===		===Laboratories===
	"The major national reference labs including Quest, LabCorp, Specialty/Ameripath, Mayo and others account for at least 60% of the market for esoteric test services. The remaining 40% is shared by a group of some 3000 small, local market laboratories. The major reference labs have built a comprehensive menu of specialized test services and continue to expand their offerings via collaborations with leading medical research centers. They offer a huge presence in the market and manage distribution networks that touch just about every medical specialty. Thus many CLIA-registered company sponsored test services avail themselves of the marketing resources offered by the national reference labs."		"The major national reference labs including Quest, LabCorp, Specialty/Ameripath, Mayo and others account for at least 60% of the market for esoteric test services. The remaining 40% is shared by a group of some 3000 small, local market laboratories. The major reference labs have built a comprehensive menu of specialized test services and continue to expand their offerings via collaborations with leading medical research centers. They offer a huge presence in the market and manage distribution networks that touch just about every medical specialty. Thus many CLIA-registered company sponsored test services avail themselves of the marketing resources offered by the national reference labs."

DavidO: /* LDTs */

2010-07-01T21:21:40Z

LDTs

← Older revision		Revision as of 21:21, 1 July 2010
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	===LDTs===		===LDTs===

	LDTs can be developed in two ways. ~~Primarily~~, ~~these~~ tests utilize ASRs which are developed in-house, solely for use within the laboratory. The test designs and procedures are proprietary to the laboratory and are not sold for use to any outside entities. In short, the laboratory is markets the test to and obtains the necessary specimens directly from consumers. Once received, the specimen is processed in the test and results are reported directly back to the consumer in writing or on the internet through a secure website interface. As previously mentioned, this type of LDT is not subject to the same level of regulatory oversight as is an IVD.		LDTs can be developed in two ways. First, the majority of LDT tests utilize ASRs which are developed in-house, solely for use within the laboratory. The test designs and procedures are proprietary to the laboratory and are not sold for use to any outside entities. In short, the laboratory is markets the test to and obtains the necessary specimens directly from consumers. Once received, the specimen is processed in the test and results are reported directly back to the consumer in writing or on the internet through a secure website interface. As previously mentioned, this type of LDT is not subject to the same level of regulatory oversight as is an IVD.

	A second, but somewhat less common method of developing an LDT, is accomplished when a laboratory develops the test design and procedures, but does not develop the necessary ASRs for use in the test. Instead, the laboratory obtains the ASRs by purchasing them from an outside entity and incorporates the ASRs into their test. In this circumstance, the test is marketed and conducted in the same manner as the other type of LDT. Unlike the completely proprietary LDTs which are not subject to stringent regulation, the process of purchasing ASRs is subject to some regulation, but still not as much as is the IVDs. Importantly, the ''sellers'' of the ASRs, rather than the LDT laboratories, tend to be the entities who must satisfy federal regulations for the sale of ASRs. For this reason, this type of LDT is still an attractive option when a laboratory cannot develop and entirely proprietary LDT.		A second, but somewhat less common method of developing an LDT, is accomplished when a laboratory develops the test design and procedures, but does not develop the necessary ASRs for use in the test. Instead, the laboratory obtains the ASRs by purchasing them from an outside entity and incorporates the ASRs into their test. In this circumstance, the test is marketed and conducted in the same manner as the other type of LDT. Unlike the completely proprietary LDTs which are not subject to stringent regulation, the process of purchasing ASRs is subject to some regulation, but still not as much as is the IVDs. Importantly, the ''sellers'' of the ASRs, rather than the LDT laboratories, tend to be the entities who must satisfy federal regulations for the sale of ASRs. For this reason, this type of LDT is still an attractive option when a laboratory cannot develop and entirely proprietary LDT.

← Older revision		Revision as of 21:15, 16 October 2010
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	==Legal Aspects of Diagnostics==		==Legal Aspects of Diagnostics==
	===[[Diagnostic Kits/Case Law Review\|Case Law Review]]===		===[[Diagnostic Kits/Case Law Review\|Case Law Review]]===
	~~===[[Diagnostic Kits/Literature Review\|Literature Review]]===~~
	===[[Diagnostic Kits/Country Reports Review\|Country Reports Review]]===		===[[Diagnostic Kits/Country Reports Review\|Country Reports Review]]===
	===[[Diagnostic Kits/USA Regulation Review\|USA Regulation Review]]===		===[[Diagnostic Kits/USA Regulation Review\|USA Regulation Review]]===