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GENOMICS

Droplet Digital™ PCR

We offer a broad range of blood-based ddPCR solutions for our biopharma partners.

ddPCR Platform Overview

Droplet Digital PCR (ddPCR™) is a highly sensitive form of PCR that is based on the partitioning of DNA into droplets. It is a highly precise technology platform that has been recently optimized in oncology for clinical analysis of cell-free DNA (cfDNA) and cell-free RNA (cfRNA) in plasma to detect targeted tumor mutations and translocations. We use the Bio-Rad QX200 ddPCR system and QuantaSoft Software for data analysis.

Key Benefits of ddPCR

icon-sample Blood-Based
bdx-clock-icon Fast Project Turnaround
3Asset 28 Custom Designed Assays
icon-target Highly Accurate
icon-chart Quantitative
icon-clinical-testing PMA Ready QMS

GeneStrat® Test

The GeneStrat® test is our on-market genomic test using ddPCR to analyze cfDNA and cRNA. GeneStrat delivers actionable, blood-based genomic test results within 72 hours for patients with non-small cell lung cancer. GeneStrat covers actionable mutations in the following genes: EGFR (L858R, Del19, G719X, L861Q, S768I, T790M) ALK | ROS1 | RET | KRAS | BRAF

Learn more about our clinical diagnostic test: GeneStrat

PD-L1 Expression

Our blood-based PD-L1 assay measures both PD-L1 expression and tumor load (as reflected by CK19) through multiplexed ddPCR detection of circulating mRNA. The assay is currently in validation.

PD-L1 Assay One-Pager

Mellert 2017 (ASCO-SITC) - Feasibility Data

Microsatellite Instability

Microsatellite instability (MSI) has emerged as a relevant biomarker for guiding patient treatment with immune checkpoint inhibitors. We provide our partners with a blood-based ddPCR assay that quantitatively identifies mutations in five loci (BAT25/BAT26, NR21/NR24, and Mono27) that lead to the identification of MSI status.

Data coming soon at AMP 2019!

Custom Assay (e.g., EGFR C797S)

We develop custom blood-based assays based on your individual needs. We offer a menu of ddPCR mutation detection assays, and design multiplexed assays, to help with targeting in your drug development programs. Our partners use our tests for preclinical biomarker work, retrospective analyses, clinical study enrollment, treatment monitoring, and coordinated commercial deployment. We can analytically and clinically validate ddPCR assays in our CLIA/CAP/NYS CLEP/ISO 13485-certified laboratory.

Download Our Custom ddPCR Assay List

“If you are looking for a PCR-based focused assay, then ddPCR is perfect. It’s faster and cheaper, and it is the most robust method of achieving an answer. ddPCR is the ‘best in class’, because it is quantitative, extremely sensitive, and shows very high specificity. This is why the technology has become our ‘go-to’ PCR assay for both plasma cell-free DNA and tumor DNA genotyping.”

– Dr. Geoffrey Oxnard, SelectScience Interview, August 2017.