SAGA Diagnostics announces CE-marking of SAGAsafe® EGFR T790M assay and hiring of two Sales Managers
LUND, Sweden — /October 20, 2020/ — SAGA Diagnostics AB, a cancer liquid biopsy and genomic testing company focused on precision oncology and non-invasive ultrasensitive monitoring of cancer patients, today announced the CE IVD-marking of its SAGAsafe® EGFR T790M assay*.
The assay is a digital PCR test run on cell-free DNA (cfDNA) obtained from a simple blood sample. It achieves industry-leading performance by employing the patented SAGAsafe® technology which in comparison to traditional approaches enhances true-positive signals and at the same time reduces false-positive signals. This leads to a 100- to 1000-fold improvement in detection limit compared to competitor technologies and kits. The SAGAsafe® EGFR T790M mutation detection assay features a limit of detection of 0.0037% mutant allele frequency (MAF) and may be ordered as kit product or as a service test.
Sequential use of anti-EGFR tyrosine kinase inhibitors (TKI) is standard practice for non-small cell lung cancers that are positive for an EGFR activating mutation. Resistance to early TKI therapy due to an EGFR T790M mutation arises in about 50% of cases. Patients with T790M mutation can then be treated with approved 3rd generation drugs. Therefore, in this situation the presence of T790M is important information and should be tested using a reliable, rapid, cost-effective, and minimally invasive method. The fact that SAGAsafe® EGFR T790M is performed on cfDNA obtained from a simple blood sample means that the assay can be used when tissue is unavailable and allows for easy and low-cost repetition of testing for monitoring T790M mutation status over time.
We are pleased to be able to now offer the CE-IVD marked SAGAsafe EGFR T790M assay to the diagnostics market. Providing a liquid biopsy-based digital PCR test with a limit of detection that is well below those shown by traditional methods means that more mutations can be detected earlier and even in patients for which invasive tissue samples are unobtainable. We therefore believe that this assay will make a difference in many cancer patients’ lives.
– Anthony George, CTO and co-founder of SAGA Diagnostics.
This first CE-IVD mark is an important regulatory milestone for SAGA and paves the way for broadening our portfolio of CE-IVD SAGAsafe kits chosen from over 200 RUO mutation tests already developed. We are also well prepared for the changes that lay ahead with the IVD Regulation.
– Karolina Holm, Director of Clinical Laboratory Quality Assurance.
Further information about the assay can be found on the SAGA Diagnostics website at sagadiagnostics.com/t790m.
To bring this new product to the market, together with our other commercially-available SAGAsafe and SAGAsign products and services, SAGA Diagnostics also announces the appointment of Julio Lopez, Sales Manager Spain, and Sven Langner, Sales Manager Germany. Joining the team on September 1, Julio and Sven come with many years of experience with sales and business development for molecular diagnostics products, with prior experiences at companies such as Qiagen and Bio-Rad, respectively.
SAGA hits the ground running with the launch of the new CE-IVD marked kit and expansion of the sales team with Sven and Julio. Traction with biopharma companies has been high, and we have high ambitions in Europe and are preparing for other markets such as the USA.
– Åke Nilsson, Director of Business and Corporate Development
* The CE-IVD product is not commercially available in all countries.
Contact: CEO Lao Saal, MD PhD. email@example.com Phone: +46 (0) 733 01 7242
About SAGA Diagnostics AB
SAGA Diagnostics AB is a personalized cancer genomics and disease monitoring company that offers molecular genetic testing of tissue biopsies and non-invasive “liquid biopsies” such as blood samples. SAGAsafe® is part of a portfolio of ultrasensitive technologies, which also includes SAGAsign® for personalized monitoring of cancer burden using chromosomal rearrangements, as well as novel technologies in development. SAGA helps pharmaceutical companies, scientists, and healthcare providers to detect actionable mutations, stratify patient groups, and monitor treatment response more accurately and to an industry-leading lower limit of detection of 0.001%. Analysis of circulating tumor DNA using these proprietary technologies gives SAGA unique ultrasensitivity, and provides the basis for optimal decision-making.