SYNLAB Pharma, a subsidiary of SYNLAB Holding Deutschland GmbH announces that it has signed a collaboration agreement with Biotype with the intention to offer a Europe-wide clinical trial service for MSI and POLE/POLD1 mutation detection to indicate if patients harboring from GI cancer or EC would benefit from immune checkpoint inhibitor therapy. The tests will be performed with the Modaplex technology, a PCR load-and-go-away benchtop system that is used to detect all types of genetic aberrations simultaneously in just 3.5 hours
Under the agreement, the tests will be verified according to CAP or CLIA guidelines for clinical research organizations allowing for an immediate application of these assays in a clinical trial environment. The service will be initially set up at SYNLAB Germany (Oncoscreen) and is easily further expandable “Our desire is that through this collaboration more pharmaceutical companies and CROs will gain access to a multicenter laboratory service which is, in fact, as comfortable as planning and performing a single center study,” said Dr. Martin Roskos, Chief Medical Officer at SYNLAB Holding Deutschland GmbH.
Blocking of immune checkpoint pathways by targeting the PD-1/PD-L1 axis have proven clinical response to a variety of tumor entities1,2, but still there is a great heterogeneity in clinical response. MSI and POLE/POLD1 exonuclease domain mutations are indicated as suitable marker to identify patients most likely to derive benefit from ICI therapies3,4,5,6. Both are common events in GI cancers and EC, they are associated with increased number of neo-antigens and T-Cell infiltration and a co-occurrence between the phenotypes MSI-High and high tumor mutational burden (TMB-high) have been reported for gastrointestinal cancers7. With the Modaplex platform, Biotype supports SYNLAB´s philosophy of a highly effective laboratory service, said Dr. Karim Tabiti, Chief Executive Officer at Biotype. “This collaboration provides clients with a great set of MSI and POLE/POLD1 information in a time- and cost-effective manner.”
Both companies state that the Modaplex MSI Analysis Kit and the complementary Modaplex POLE/POLD1 Mutation Analysis Kit are just the beginning of the further cooperation of molecular multi-analyte testing services on the Modaplex platform.
- D.M. Pardoll,et al, “The blockade of immune checkpoints in cancer immunotherapy”, Nature Reviews Cancer, vol. 12, pp. 252-264, 2012.
- M.A. Postow et al, “Immune Checkpoint Blockade in Cancer Therapy”, Journal of Clinical Oncology, vol. 33, no. 17, pp. 1974-1983, 2015.
- D.T. Le et al, “PD-1 Blockade in tumors with Mismatch-Repair Deficiency”, N. Engl. J. Med., vol. 372, pp. 2509-2520, 2015.
- D.T. Le et al, “Mismatch-repair deficiency predicts response of solid tumors to PD-1 blockade”, Science, vol. 357, no. 6349, pp. 409-413, 2017.
- R. Bourdais et al, “Polymerase proofreading domain mutations: New opportunities for immunotherapy in hypermutated colorectal cancer beyond MMR deficiency”, Crit. Rev. Oncol. Hematol., vol. 113, pp. 242-248, 2017.
- J.M. Mehnert et al, “Immune activation and response to pembrolizumab in POLE-mutant endometrial cancer”, J. Clin. Invest., vol. 126, no. 6, pp. 2334-2340, 2016.
- Z.R. Chalmers et al, “Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden”, Genome Medicine, vol. 9, no. 34, 2017.
- SYNLAB Group is the leading medical diagnostics services provider in Europe. SYNLAB offers a full range of innovative and reliable medical diagnostics for patients, practising doctors, clinics and the pharmaceutical industry
- Providing the leading level of service within the industry, SYNLAB is the partner of choice for healthcare professionals. SYNLAB’s services also encompass veterinary and environmental laboratory analysis.
- SYNLAB operates in more than 40 countries across four continents and holds leading position in most markets. Over 20,000 employees contribute every day to the Group’s success across different geographies. SYNLAB carries out approximately 500 million laboratory tests per year, achieving sales revenues of ca. EUR 1.9 billion.
- More information can be found on www.synlab.com
- Biotype develops, produces, and offers molecular diagnostic products and OEM-services.
- Aside from assays, the company provides the unique Modaplex technology, which enables the examination of up to fifty different DNA/RNA targets simultaneously and thus simplifies complexities in molecular diagnostic approaches.
- Biotype’s OEM-services cover all the challenges ranging from the idea up to marketable products on various platforms.
- For more information visit: www.biotype.de