Testing Services

Wide-ranging studies of genetic aberrations have identified recurrent genomic abnormalities as potential driving factors underlying a variety of cancers and other diseases.

At PacificDx Testing Services, we support many of these leading-edge molecular and non-molecular technologies for diagnostic biomarker interrogation, drug selection targeting and therapeutic monitoring. These include but are not limited to Next Generation Sequencing (NGS), Enzyme-linked immunosorbent assay (ELISA), Flow Cytometry and Real-Time PCR and Immunohistochemistry (IHC). If you don’t see what you are looking for, please ask — we are a premier high-complexity molecular laboratory with advanced capabilities.

Please visit our companion diagnostics company, ResearchDx, to learn how our IVD and biopharma development services can simplify delivery of your FDA-approved companion diagnostics on time.

Our Testing Services

Gluten ID Test for Celiac Disease Risk

The Gluten ID Test serves as a diagnostic aid for identifying genetic alterations encoding gluten recognition immune receptors. The absence of genetic alterations can rule out celiac disease risk with a predictive value of 99%.

For more information please visit our Gluten ID Test page..

For Patients: For information on obtaining the test, please visit Targeted Genomics.

ibs-smart™ for irritable bowel syndrome (IBS-D)

The ibs-smart™ assay serves as a diagnostic aid for IBS-D especially post-infection by providing relevant immunological information about antibodies to cytothelial distending toxin B (CdtB) and vinculin.

For more information please visit our ibs-smart™ page.

For Patients: For information on obtaining the test, please visit: ibs-smart.com.

trio-smart™ breath test for hydrogen, methane, and hydrogen sulfide

trio-smart™ uses the established breath testing method for characterizing fermentation patterns in the gastrointestinal tract in the assessment of small intestinal bacterial overgrowth (SIBO).

For more information please visit our trio-smart™ page.

For patients: For information about ordering this test, visit www.trio.smart.com.

PlasmaDx Test Suite

The PlasmaDx Test Suite is a collection of circulating tumor (ct)DNA assays validated for use in our CAP/CLIA certified laboratory covering a wide variety of clinical oncology scenarios .

For more information please visit our Plasma Dx page.

For patients: Talk with your physician about ordering liquid biopsy for non-invasive solid tumor analysis.

HADL30 NGS

HADL30 NGS, the Children’s Hospital of Orange County (CHOC) Hematology Advanced Diagnostics Laboratory (HADL) 30 gene panel, is an NGS assay designed to detect germline alterations in 30 genes associated with rare blood disorders including ADAMTS13, MTHFR, SERPINE1, and TBXA2R.

For more information please visit our HADL30 NGS Test page.

For patients: visit cibd-ca.org/about.

EsoGuard™ Esophageal DNA Test

EsoGuard™ is an NGS methylation assay developed and validated for the qualitative detection of Barrett’s esophagus (BE) and associated esophageal preneoplastic (dysplasia) correlating with methylated DNA markers in the esophageal lining.

For more information please visit our EsoGuard™ page.

For patients: For information about ordering this test, visit www.luciddx.com.

CD8 by Immunohistochemistry (IHC)

The CD8 antibody reacts with the 32 kDa CD8 protein and stains cells with cytotoxic activity including cortical thymocytes, cytotoxic/suppressor T-cells and a subset of natural killer (NK) cells.

Methodology: PacificDx performs CD8 using the Biocare mouse monoclonal antibody [C8/144B] for qualitative identification of CD8 protein by IHC in formalin fixed paraffin embedded (FFPE) tissue.

Gluten ID Test for Celiac Disease Risk

The Gluten ID Test serves as a diagnostic aid for identifying genetic alterations encoding gluten recognition immune receptors. Absence of genetic alterations can rule out celiac disease risk with a predictive value of 99%. Get comprehensive information by visiting our Gluten ID Test page.

For Patients: For information on obtaining the test, please visit Targeted Genomics.

ibs-smart™ for irritable bowel syndrome (IBS-D)

Get comprehensive information by visiting our ibs-smart™ page.

For Patients: For information on obtaining the test, please visit: ibs-smart.com

MCL-1 Dependency Assay

Overexpression of MCL-1 leads to resistance to programmed cell death in acute myelogenous leukemia (AML) and other cancers. Inhibition of the MCL-1 pathway in this subset of MCL-1 dependent AML patients results in improved sensitivity to chemotherapy.

Methodology: The MCL-1 dependency priming assay uses flow cytometry to measure MCL-1 dependency of bone marrow blasts in patients with AML.

NSCLC Targeted Sequencing Panel by NGS

Multiplex testing of squamous and non-squamous NSC lung cancer tissue allows interrogation of a maximum number of biomarkers from minimal tumor tissue.

Methodology: Sequencing of uniquely indexed target enriched libraries is performed using an Illumina MiSeq instrument with bioinformatics analysis through an assay specific pipeline. This assay only reports the following variants in the following genes:

MET:	Reported areas include Point mutations and Ins/Del
AXL:	Chromosomal rearrangements including but not limited to MBIP-AXL (or alternative) and amplifications
KRAS:	Point mutations involving codon 12, 13, 61
EGFR:	Point mutations and Ins/Del: L858R, T790M, G719A/D/S, S768I, L861Q/R, Exon 20ins, Exon 19del
ALK:	Rearrangements including but not limited to EML4-ALK
BRAF:	Point mutations: V600E, V600D, V600K, V600R, G464V, G466E, G466E, G466A, G469V, G469L, G469R, G469A, N581S, N581T, D594N, D594H, D594G
ROS:	Chromosomal rearrangements including but not limited to CD74-ROS, EZR-ROS, SDC4-ROS, SLC34A2-ROS, TPM3-ROS
RET:	Point mutations including, but not limited to, C630R, C634R/W/Y, M918T, Chromosomal rearrangements including but not limited to KIF5B-RET or CCDC6
NTRK1:	Chromosomal rearrangements including but not limited to MPRIP-NTRK1, CD74-NTRK1, TPM3-NTRK1, TFG-NTRK1
NTRK2:	Point mutations: R715G, M713I, R734C