{"product_id":"seracare-seraseq-ffpe-tmb-reference-material-0710-1310","title":"Seraseq® FFPE TMB Reference Material","description":"\u003cp\u003eIn immuno-oncology, the goal is to enable a patient’s immune system to locate and eliminate cancerous cells. The immune system may normally protect against cancer – except, when cancers manage to evade it – since immunocompromised individuals have a higher likelihood of developing cancer. Checkpoint inhibitors, which have recently improved the prognosis for a significant number of cancer patients, work by blocking inhibitory molecules such as PD-L1 and CTLA-4 that may be allowing cancers to evade the adaptive immune system. However, by taking the brakes off the immune system, the use of checkpoint inhibitors is associated with a significant risk of developing autoimmune disease. Additionally, frequently checkpoint inhibitors are not effective.\u003c\/p\u003e\u003cp\u003eIn order to maximize the safety and efficacy of checkpoint inhibitors, it is beneficial to identify patients who are likely to respond to their use. Since the adaptive immune system can detect changes to proteins, it is thought that the number of somatic mutations that lead to such changes may be correlated with efficacy. The metric of non-silent somatic mutations per megabase of coding DNA has been termed tumor mutational burden (TMB), which has shown some correlation to the efficacy of checkpoint inhibitors. Assessments of TMB are being added to many NGS assays order to enable their use for patient selection for clinical trials and perhaps later as companion diagnostics. However, it is also known that TMB scores can differ significantly between assays and especially around levels that may be clinical decision points.\u003c\/p\u003e\u003cp\u003eTo improve and harmonize the measurement of TMB, we have generated and characterized tumor-normal human cell lines with different TMB scores for whole exome sequencing analysis of TMB in patient samples, for validating targeted NGS panel-based TMB assays, and as controls for TMB measurements in I-O clinical trial projects.\u003c\/p\u003e\u003cp\u003eThe TMB reference materials are available as genomic DNA (purified mix) format and\/or FFPE (require extraction) format, as tumor-normal standards.\u003c\/p\u003e\u003cp\u003eFFPE TMB Reference Standards:\u003cbr\u003eReference standards are made from human lung cancer cell lines at 30% tumor content, formalin-treated and paraffin-embedded into FFPE blocks, which are then cut into 10 µm sections.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e30% tumor-normal FFPE reference standards\u003c\/li\u003e\n\u003cli\u003ecompatible with a range of FFPE extraction kits\u003c\/li\u003e\n\u003cli\u003erange of TMB scores\u003c\/li\u003e\n\u003cli\u003emanufactured in GMP-compliant and ISO 13485 certified facilities\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eSpecifications\u003c\/h2\u003e\u003ctable\u003e\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003eSize\u003c\/td\u003e\n\u003ctd\u003e10 µm\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFormat\u003c\/td\u003e\n\u003ctd\u003eFFPE\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\u003c\/table\u003e\u003ch2\u003eDocuments\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\u003ca href=\"https:\/\/www.seracare.com\/globalassets\/seracare-resources\/PS-MKT-00504-04-0710-1326.0710-1325.0710-1586.0710-1324.0710-1323.0710-2087.0710-2088.0710-2089.0710-2090.0710-1310.0710-1308.0710-1618.0710-1309.0710-1307.Seraseq_gDNA_ctDNA_and_FFPE_TMB_Products.pdf\" target=\"_blank\" rel=\"noopener\"\u003eSeraseq gDNA, ctDNA and FFPE TMB Product Sheet (Product Sheet)\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"https:\/\/www.seracare.com\/globalassets\/seracare-resources\/ds-0710-13070710-13080710-13090710-1310-seraseq-ffpe-tmb-rm-score-7-9-20-26.pdf\" target=\"_blank\" rel=\"noopener\"\u003eSeraseq FFPE TMB RM (Data Sheet)\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"https:\/\/www.seracare.com\/globalassets\/seracare-resources\/pi-0710-1307.1308.1309.1310-seraseq-ffpe-tmb-rm.pdf\" target=\"_blank\" rel=\"noopener\"\u003eSeraseq FFPE TMB RM Products (Package Insert)\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"https:\/\/www.seracare.com\/globalassets\/seracare-resources\/sds-seraseq-ffpe.pdf\" target=\"_blank\" rel=\"noopener\"\u003eSeraseq FFPE Safety Data Sheet (Safety Data Sheet)\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eOrdering Information\u003c\/h2\u003e\u003ctable\u003e\n\u003cthead\u003e\u003ctr\u003e\n\u003cth\u003eCat. no.\u003c\/th\u003e\n\u003cth\u003eProduct\u003c\/th\u003e\n\u003cth\u003eSize\u003c\/th\u003e\n\u003cth\u003eTMB Score\u003c\/th\u003e\n\u003cth\u003eDNA Yield\u003c\/th\u003e\n\u003cth\u003eDNA Yeild\u003c\/th\u003e\n\u003c\/tr\u003e\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e0710-1310\u003c\/td\u003e\n\u003ctd\u003eSeraseq® FFPE TMB RM Score 7\u003c\/td\u003e\n\u003ctd\u003e2 x 10 µm\u003c\/td\u003e\n\u003ctd\u003e7.2 ± 0.4 #\u003c\/td\u003e\n\u003ctd\u003e\u0026gt;100 ng\u003c\/td\u003e\n\u003ctd\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e0710-1308\u003c\/td\u003e\n\u003ctd\u003eSeraseq® FFPE TMB RM Score 9\u003c\/td\u003e\n\u003ctd\u003e2 x 10 µm\u003c\/td\u003e\n\u003ctd\u003e7.5\u003c\/td\u003e\n\u003ctd\u003e\u0026gt;100 ng\u003c\/td\u003e\n\u003ctd\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e0710-1618\u003c\/td\u003e\n\u003ctd\u003eSeraseq® FFPE TMB RM Score 13\u003c\/td\u003e\n\u003ctd\u003e2 x 10 µm\u003c\/td\u003e\n\u003ctd\u003e12.1 ± 0.3 #\u003c\/td\u003e\n\u003ctd\u003e\u003c\/td\u003e\n\u003ctd\u003e\u0026gt;100 ng\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e0710-1309\u003c\/td\u003e\n\u003ctd\u003eSeraseq® FFPE TMB RM Score 20\u003c\/td\u003e\n\u003ctd\u003e2 x 10 µm\u003c\/td\u003e\n\u003ctd\u003e18.6 ± 0.5 #\u003c\/td\u003e\n\u003ctd\u003e\u0026gt;100 ng\u003c\/td\u003e\n\u003ctd\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e0710-1307\u003c\/td\u003e\n\u003ctd\u003eSeraseq® FFPE TMB RM Score 26\u003c\/td\u003e\n\u003ctd\u003e2 x 10 µm\u003c\/td\u003e\n\u003ctd\u003e22.8 ± 3.6 #\u003c\/td\u003e\n\u003ctd\u003e\u0026gt;100 ng\u003c\/td\u003e\n\u003ctd\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e","brand":"SeraCare","offers":[{"title":"Score 7","offer_id":46798510686287,"sku":"0710-1310","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Score 9","offer_id":46798510719055,"sku":"0710-1308","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Score 13","offer_id":46798510751823,"sku":"0710-1618","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Score 20","offer_id":46798510784591,"sku":"0710-1309","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Score 26","offer_id":46798510817359,"sku":"0710-1307","price":0.0,"currency_code":"ILS","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0712\/0748\/5519\/files\/0710-1310.jpg?v=1789655827","url":"https:\/\/www.danyel.co.il\/products\/seracare-seraseq-ffpe-tmb-reference-material-0710-1310","provider":"danyel biotech","version":"1.0","type":"link"}