first results in XL228 Trial

[Guest guest]

Hi folks, how about this for only being infused 3 times ???

ACCN: DL-08-04951

Collected:05/28/2008 08:16 MOL DX FIN MOLECULAR DIAGNOSTIC FINAL

Updated:05/30/2008 16:47

MOLECULAR DIAGNOSTIC FINAL Source:

FINAL REPORT

Test: BCR/ABL1 Quantitative Analysis

Specimen Type: BLOOD

Description of Method: Reverse transcription of extracted RNA with an

ABL1

reverse primer is followed by quantitative real time polymerase chain

reaction

using fluorescent probes specific for ABL1 and BCR/ABL1 transcripts.

The

assay will detect BCR/ABL1 p210 transcripts (b2a2, b3a2) as well as

BCR/ABL1

p190 transcripts (e1a2). BCR/ABL1 b2a2, b3a2, e1a2 and ABL transcripts

are

quantified by comparison to standard curves produced using cloned

plasmid

DNA. The number of BCR/ABL1 transcripts is normalized to the number of

ABL1

transcripts in the specimen and the result is reported as a ratio, in

percent,

of BCRABL1/ABL1. For quantitative results, the assay has a detection

limit of

5 copies of BCR/ABL1 transcript per sample.

=============================================================================

RESULTS: POSITIVE

Breakpoint identification: p210(b2a2 & b3a2) Reference Interval:

Negative

Quantitative Results:

% BCRABL1(b2+b3)/ABL1: 0.583 Reference Interval:

Negative

% BCRABL1(e1)/ABL1: 0.0 Reference Interval:

Negative

=============================================================================

INTERPRETATION:

This specimen is positive for the p210(b2a2 & b3a2) BCR/ABL1

transcript.

Previous testing on 4/21/08 resulted in a quantitation of 6.197%

BCRABL1/ABL1.

The difference between the current result and the previous result is

greater

than 3-fold and is therefore analytically significant.

Clinicopathologic correlations are recommended.

This test was developed and its performance characteristics determined

by the

Molecular Diagnostics Laboratory. It has not been cleared nor approved

by the

U.S. Food and Drug Administration. The FDA has determined that such

clearance

is not necessary. This test is used for clinical purposes. It should

not be

regarded as investigational or for research. This laboratory is

certified

under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88)

as

qualified to perform high complexity clinical laboratory testing.

I, Kojo Elenitoba-, MD, the signing staff pathologist, have

personally

reviewed and interpreted the data from this test.

1 MD02; 4 MD98; 4 MD96

Kojo Elenitoba- M.D.

a (Bobby) Doyle

Brecksville, Ohio, USA

DX 05/1995

02/2000 - Gleevec Trial/OHSU

06/2002 - Gleevec/Trisenox Trial/OHSU

06/2003 - Gleevec/Zarnestra Trial/OHSU

04/2004 - Sprycel Trial/MDACC, CCR in 10 months

#840 - Zavie's Zero Club

09/2006 - out of CCR

04/29/08 - XL228 Trial/ U.of Michigan

[Guest guest]

That sounds very exciting Bobby! Congratulations.

Tracey

>

> Hi folks, how about this for only being infused 3 times ???

>

> ACCN: DL-08-04951

> Collected:05/28/2008 08:16 MOL DX FIN MOLECULAR DIAGNOSTIC FINAL

> Updated:05/30/2008 16:47

> MOLECULAR DIAGNOSTIC FINAL Source:

>

>

>

> FINAL REPORT

> Test: BCR/ABL1 Quantitative Analysis

>

> Specimen Type: BLOOD

>

> Description of Method: Reverse transcription of extracted RNA with

an

> ABL1

> reverse primer is followed by quantitative real time polymerase

chain

> reaction

> using fluorescent probes specific for ABL1 and BCR/ABL1 transcripts.

> The

> assay will detect BCR/ABL1 p210 transcripts (b2a2, b3a2) as well as

> BCR/ABL1

> p190 transcripts (e1a2). BCR/ABL1 b2a2, b3a2, e1a2 and ABL

transcripts

> are

> quantified by comparison to standard curves produced using cloned

> plasmid

> DNA. The number of BCR/ABL1 transcripts is normalized to the

number of

> ABL1

> transcripts in the specimen and the result is reported as a ratio,

in

> percent,

> of BCRABL1/ABL1. For quantitative results, the assay has a

detection

> limit of

> 5 copies of BCR/ABL1 transcript per sample.

>

======================================================================

=======

> RESULTS: POSITIVE

>

> Breakpoint identification: p210(b2a2 & b3a2) Reference Interval:

> Negative

>

> Quantitative Results:

> % BCRABL1(b2+b3)/ABL1: 0.583 Reference Interval:

> Negative

> % BCRABL1(e1)/ABL1: 0.0 Reference Interval:

> Negative

>

======================================================================

=======

> INTERPRETATION:

> This specimen is positive for the p210(b2a2 & b3a2) BCR/ABL1

> transcript.

>

> Previous testing on 4/21/08 resulted in a quantitation of 6.197%

> BCRABL1/ABL1.

>

> The difference between the current result and the previous result is

> greater

> than 3-fold and is therefore analytically significant.

>

> Clinicopathologic correlations are recommended.

>

> This test was developed and its performance characteristics

determined

> by the

> Molecular Diagnostics Laboratory. It has not been cleared nor

approved

> by the

> U.S. Food and Drug Administration. The FDA has determined that such

> clearance

> is not necessary. This test is used for clinical purposes. It

should

> not be

> regarded as investigational or for research. This laboratory is

> certified

> under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-

88)

> as

> qualified to perform high complexity clinical laboratory testing.

>

> I, Kojo Elenitoba-, MD, the signing staff pathologist, have

> personally

> reviewed and interpreted the data from this test.

>

> 1 MD02; 4 MD98; 4 MD96

> Kojo Elenitoba- M.D.

>

>

>

>

> a (Bobby) Doyle

> Brecksville, Ohio, USA

> DX 05/1995

> 02/2000 - Gleevec Trial/OHSU

> 06/2002 - Gleevec/Trisenox Trial/OHSU

> 06/2003 - Gleevec/Zarnestra Trial/OHSU

> 04/2004 - Sprycel Trial/MDACC, CCR in 10 months

> #840 - Zavie's Zero Club

> 09/2006 - out of CCR

> 04/29/08 - XL228 Trial/ U.of Michigan

>

>

>

>