press release

Preliminary SNAQ BCR-ABL Pilot results presented at the 16th Annual John Goldman
Conference on Chronic Myeloid Leukemia
Wilmington, NC. September 6 2014. AccuGenomics presented preliminary results of the SNAQ
BCR-ABL pilot study conducted with MD Anderson at the 16th Annual John Goldman
Conference on Chronic Myeloid Leukemia.
The molecular tests for measuring of Philadelphia chromosome blood abundance has proven to
be an invaluable tool for monitoring CML treatment. However, despite intense international
efforts to control for process variation between clinical laboratories, there remains a need to
standardize CML abundance testing. As part of AccuGenomics plan to create clinical tests based
on its Standardized Nucleic Acid Quantification (SNAQ), AccuGenomics developed a method to
standardize CML testing. The preliminary results presented at the conference supports
AccuGenomics standardization claims.
“Attempts to use external reference standards or automation to control for variation in reagent,
instrument and sample has failed to achieve the desired BCR-ABL interlaboratory
standardization”, says Dr. Tom Morrison, CSO of AccuGenomics. SNAQ BCR-ABL method is
based on a novel ratiometric approach to eliminate the liquid handling, amplification and
detection variation. In addition, SNAQ has intrinsic quality controls to detect processing errors.
“Molecular testing is a complex, sensitive to process errors that can go undetected. SNAQ
analysis software performs over 30 quality control checks to prevent erroneous reporting.”
The SNAQ BCR-ABL pilot study compares the CML test process between two CLIA laboratory
developed tests (LDT) and the SNAQ method performed in these labs. CML patients provided
samples as part of their routine monitoring; these blood samples were sent to two sites, each of
which performed LDT and SNAQ methods. The preliminary data was drawn from analysis of
75% of the total sample recruitment. The %BCR-ABL LDT reported very different
measurements, differing by 7-fold, whereas the SNAQ results had no bias. Additionally, only
the LDT methods had outliers. These results indicate that the LDT process controls were
insufficient, whereas the SNAQ BCR-ABL intrinsic controls would support CML monitoring
The sample testing is expected to be completed in October 2014 and presented by the study’s
lead Dr. Jorge Cortes, University of Texas MD Anderson Center.
About Chronic Myeloid Leukemia
Chronic Myeloid Leukemia (CML) is a blood cancer that is often associated with a Philadelphia
chromosome rearrangement. CML is characterized as to uncontrolled growth of immature cells
that make a certain type of white blood cell called myeloid cells. The diseased cells build up in
the bone marrow and blood. In time, the cells can also invade other parts of the body, including
the spleen. CML can also change into a fast-growing acute leukemia that invades almost any
organ in the body.
About Standardized Testing
Deployable molecular tests based on transcript abundance signatures has proven unreliable due
to its sensitivity to variations in reagent handling, reagent specificity, instrument drift, and
specimen quality. The predictive performance of complex transcript abundance signatures is
reduced by the method variation and drift. AccuGenomics offers several transcript abundance
methodologies that control for these variations to ensure every measurement was made correctly.
These methods are ideal for development of kits that make many abundance measurements from
limited degraded samples.
About AccuGenomics
AccuGenomics is a diagnostic company focused on developing standardized molecular
diagnostic tests in oncology utilizing its patented technology. These tests will generate disease
specific data that provide accuracy and intrinsic quality control for patient solutions. Additional