Tag-it pannels

CFTR

Tm Bioscience introduces the Tag-It™ Cystic Fibrosis Kit*, the first FDA cleared IVD for cystic fibrosis genotyping.

Current recommendations by the American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG)^1,2, include screening for 23 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The Tag-It™ Cystic Fibrosis Kit* screens for these mutations in addition to 16 mutations commonly found in the ethnically diverse North American population.

Also available are Tag-It™ Investigational Use Only (IUO) Kits to investigate performance on up to 70 mutations and 6 variants (polymorphisms) in the CFTR gene.

Cystic Fibrosis Kit*

* For In Vitro Diagnostic Use.

1. Genetics in Medicine, 2001 Mar-Apr;3(2):149-154.
2. Genetics in Medicine, 2004 Sep-Oct;6(5):387-91.

Products
Tag-It™
CFTR 70+6^†

The Tag-It™ CFTR 70+6 Mutation Detection Kit simultaneously screens for 70 mutations and 6 variants (polymorphisms) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Included in the panel are the gene mutations recommended by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG) in 2004¹.

Mutations Detected
DF508	R1162X	V520F	R1066C
DI507	3849+10kbC>T	A559T	W1089X
G542X	W1282X	S549N	D1152H
G85E	N1303K	S549R (T>G)	R1158X
R117H	E60X	G622D	3791delC
621+1G>T	R75X	1078delT	S1196X
711+1G>T	405+3A>C	1677delTA	2183AA>G
R334W	406-1G>A	1812-1G>A	2307insA
R347P	444delA	1898+5G>T	Y1092X
3659delC	R117C	2055del9>A	M1101K
A455E	G178R	2143delT	S1255X
1717-1G>A	L206W	K710X	3876delA
R560T	935delA	Q890X	3905insT
R553X	DF311	2869insG	I148T
G551D	G330X	3120G>A	D1270N
1898+1G>A	R352Q	394delTT	5/7/9T
2184delA	S364P	Y122X	F508C
2789+5G>A	G480C	R347H	I507V
3120+1G>A	Q493X	3199del6	I506V
* ACMG-recommended mutations are in bold Variants are in italics 1. Genet Med. 2004 Sep-Oct;6(5):387-91.

Product Description ^†	Reagent Size (Tests)	Catalog Number
CFTR 70+6	24	R015A0072
	96	R015C0074

† For Investigational Use Only. The performance characteristics of this product have not been established.

MATERIAL SAFETY DATA SHEET [click here]

Products
Tag-It™
Cystic Fibrosis Kit^†

Tm Bioscience introduces the Tag-It™ Cystic Fibrosis Kit, the first FDA cleared IVD for cystic fibrosis genotyping. With validated performance criteria, this highly accurate and reproducible (>99.9%) assay will provide superior mutation coverage for carrier screening in adults and as an aid to diagnosis in newborns.

The Tag-It™ Cystic Fibrosis Kit simultaneously screens for the 23 CFTR gene mutations and 4 variants (polymorphisms) recommended by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG) in 2004 ¹, plus 16 of the world’s most common and North American-prevalent mutations.

The validated performance characteristics of the Tag-It™ Cystic Fibrosis Kit have been established in multisite studies demonstrating reproducibility by lot, site and operator.

Measure		Tag-It™ Assay Performance
Accuracy		100%
Precision		>99.9%
Reproducibility:	Site to site	>99.9%
	Lot to lot	>99.9%
	Operator to operator	>99.9%

Mutations Detected
DF508*	1717-1G>A*	W1282X*	2307insA
DI507*	R560T*	N1303K*	Y1092X
G542X*	R553X*	394delTT	M1101K
G85E*	G551D*	Y122X	S1255X
R117H*	1898+1G>A*	R347H	3876delA
621+1G>T*	2184delA*	V520F	3905insT
711+1G>T*	2789+5G>A*	A559T	5/7/9T
1078delT	3120+1G>A*	S549N	F508C
R334W*	R1162X*	S549R	I507V
R347P*	3659delC*	1898+5G>T	I506V
A455E*	3849+10kbC>T*	2183AA>G
* ACMG recommended, variants in italics. 1. Genet Med. 2004 Sep-Oct;6(5):387-91.

Product Description ^†	Reagent Size (Tests)	Catalog Number
Tag-It™ Cystic Fibrosis Kit	96	I006C0068

† For In Vitro Diagnostic Use

Material Safty Data Sheets: Tag-It™ 86 Population Bead Mix; Tag-It™ 10x Wash Buffer

Tag-It™
Mutation Detection Products for Coagulation

Investigational Kits for detecting mutations potentially associated with increased risk of Venous Thromboembolism
Catalog Number	Samples tested / Kit	Description
R001A0001	24	Tag-It™ Mutation Detection Kit, Factor V
R002A0004	24	Tag-It™ Mutation Detection Kit, Factor V, Factor II.
R003A0007	24	Tag-It™ Mutation detection kit Factor V, Factor II, MTHFR677, MTHFR1298.

Each kit contains:
Multiplex PCR Primers (including dNTPs),
Multiplex ASPE Primers (including dNTPs),
Bead Mix (for use on the Luminex® 100 xMAP™),
10X Wash Buffer.

For Investigational Use Only. The performance characteristics of this product have not been established.

MATERIAL SAFETY DATA SHEET [click here]

For more information on Tag-It™ Mutation Detection Kits click here

Tag-It™
Mutation Detection Kit for P450-2C19

The Tag-It™ Mutation Detection Kit for P450-2C19* provides simultaneous detection of 7 small nucleotide variants in a multiplex format, providing increased productivity without sacrificing performance.

Mutations Detected
Variant†	Major Allele
681G>A	CYP2C19*2 (A,B)
636G>A	CYP2C19*3
1A>G	CYP2C19*4
1297C>T	CYP2C19*5 (A,B)
395G>A	CYP2C19*6
IVS5+2T>A	CYP2C19*7
358T>C	CYP2C19*8
† Information was obtained from the CYP2C19 allele nomenclature database at http://www.imm.ki.se/CYPalleles/cyp2c19.htm

Investigational Kits for detecting 7 small nucleotide variants in a multiplex format.
Catalog Number	Samples tested / Kit	Description
R009A0037	24	P450-2C19

Each kit contains:

PCR Primer Mix
ASPE Primer Mix
Bead Mix
10X Wash Buffer
Tag-It^TM Data Analysis Software.

* For Investigational Use Only.The performance characteristics of this product have not been established.

MATERIAL SAFETY DATA SHEET [click here]

Tag-It™
Mutation Detection Kit for P450-2C9

The Tag-It™ Mutation Detection Kit for P450-2C9* provides simultaneous detection of 5 small nucleotide variants in a multiplex format, providing increased productivity without sacrificing performance.

Mutations Detected

Variant†
Major Allele

430 C>T

CYP2C9*2

1075 A>C

CYP2C9*3

1076 T>C

CYP2C9*4

1080 C>G

CYP2C9*5

818delA

CYP2C9*6

† Information was obtained from the CYP2C9 allele nomenclature database at http://www.imm.ki.se/CYPalleles/cyp2c9.htm

Investigational Kits for detecting 5 small nucleotide variants in a multiplex format.

Catalog Number
Samples tested / Kit
Description

R008A0020
24
P450-2C9

Each kit contains:

PCR Primer Mix
ASPE Primer Mix
Bead Mix
10X Wash Buffer
Tag-It^TM Data Analysis Software.

* For Investigational Use Only.The performance characteristics of this product have not been established.

Tag-It™
Mutation Detection Products for P450-2D6

The Tag-It™ Mutation Detection Kit for P450-2D6* provides simultaneous detection of 12 small nucleotide variants and two gene rearrangements in a multiplex format, providing increased productivity without sacrificing performance.

Mutations Detected
Variant†	Major Allele
/	Gene Duplication
/	*5
-1584C>G	*2A Promoter
100C>T	4(A-L), 10(A,B)
124G>A	*12
883G>C	*11
1023C>T	*17
1707T>del	*6(A-D)
1758G>T	*8
1846G>A	*4(A-L)
2549A>del	*3(A,B)
2613-2615 delAGA	*9
2850C>T	2,17
2935A>C	*7
† Information was obtained from the CYP2D6 allele nomenclature database at http://www.imm.ki.se/CYPalleles/cyp2d6.htm

Investigational Kits for detecting 12 small nucleotide variants and two gene rearrangements in a multiplex format.
Catalog Number	Samples tested / Kit	Description
R004A0010	24	P450-2D6

Each kit contains:
PCR Primer Mix A and B (includes dNTPs)
ASPE Primer Mix (includes dNTPs)
Bead Mix (26 populations)
10X Wash Buffer
Tag-ItTM Data Analysis Software.

* For Investigational Use Only. The performance characteristics of this product have not been established.

MATERIAL SAFETY DATA SHEET [click here]

Genomics is a constantly changing field. Each day, novel genes are being discovered and the underlying biochemical mechanisms linking these genes to various disease states are continually being identified. Single tube assays measuring a single analyte in a single reaction vessel are slowly being replaced by array-based methods capable of analyzing multiple analytes in a single reaction. Arrays provide the opportunity to advance DNA-based testing methodologies by allowing for massive parallel analysis. The Tm100 Universal Array represents a major advance in addressing the issues of flexibility, accuracy and speed:

	Genetic assays can be moved to an array format with minimal development time
	The Universal Array is compatible

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