SAGA Diagnostics offers SAGAsign® and SAGAsafe® laboratory testing as a service to SAGA partners and customers. You can choose to do the testing in your laboratory or use SAGA as your trusted supplier of the laboratory services. All our testing is carried out in our own laboratory in Sweden.
We provide a service with short turn-around time and customizable solutions. All SAGA tests are currently RUO.
SAGA operates its central laboratory in Lund, Sweden and anticipates GCLP compliance and ISO 17025 accreditation to be in place in Q1 2020, followed by ISO 13485 accreditation in Q3. CLIA/CAP facility will also be available.
Whether working with liquid or tissue biopsies, with SAGAsafe® a higher proportion of samples carrying a specific mutation can be identified. For example, when testing for mutations in the PIK3CA gene we have shown that we can identify up to 83% more patients than with targeted capture NGS. For EGFR T790M resistance mutations in non-small cell lung cancer (NSCLC), we routinely identify positive liquid biopsy samples down to 0.003% mutant allele frequency (MAF). We have tests for over 250 gene mutations and can develop custom assays to address your needs.
We assist biopharma companies with patient monitoring using liquid biopsies. ctDNA analyses can improve response monitoring as it interrogates all tumor deposits simultaneously in one test and can potentially measure tumor burden more precisely than other modalities such as imaging. For example, changes in very small tumors may be invisible or undiscernible on imaging. Moreover, radiologic pseudo-progression can give the false sense of disease progression when in fact the tumor is responding and shrinking but the mass appears larger due to inflammatory processes.
SAGA tests are inherently tumor-specific and highly quantitative. Depending on the cancer type and clinical setting, you can choose between SAGAsafe® or SAGAsign® to measure therapeutic response in your research project or clinical trial.
Either with the use of a selection of SAGAsafe® point mutations or SAGAsign® chromosomal rearrangements, minimal residual disease (MRD) can be measured with a new level of detection. This may eventually lead to patients being defined as sufficiently low-risk after surgery to not require adjuvant chemotherapy, or conversely, to up-stage patients who clearly have residual cancer after primary surgery.
SAGAsafe® technology is very suitable to be used in conjunction with therapeutic agents where therapeutic decisions can be informed using one or several biomarkers. We are keen to provide access to the best diagnostic tools available either in a direct collaboration with biopharma companies or as part of a wider consortium of highly experienced CDx developers and/or CROs. Moreover, dPCR-based CDx’s are attractive long-term solutions as clinical tests, due to the rapidly growing base of installed instruments and the entry of new global dPCR manufacturers.
Trials and Custom Solutions
In addition to the experience gathered in research studies and through clinical hospital use, SAGA is rapidly advancing its experience working with large global as well as SME pharmaceutical companies to offer tissue and liquid biopsy testing within oncology clinical trials. We are proud of our ability to customize solutions and rapidly adapt to new conditions. With our expertise in cancer genomics, dPCR, NGS, and liquid biopsies we are keen to provide you with any advice you may need.
The possibility to choose a liquid biopsy solution for our clinical trial is breaking new ground in the study of colorectal cancer. The SAGAsign® method is well suited for our needs in our current phase II study with Foxy-5.Peter Morsing, CEO of WntResearch