Tofurtheracceleratethevalidationandclinicalapplicationofliquidbiopsy-basedccfDNAtargetedNGSassays,SeracarehasdevelopedtheSeraseqctDNAComplete((TM)thatexpandscoverageofallrelevantvarianttypes(SNVs,INDELs,CNVs,andgenefusions)inasingle,highlymultiplexedreferencesample.ThesenewproductsareofferedineitherapurifiedctDNAformatoraplasma-likematrixformat,allpreciselyquantitatedbydigitalPCRagainstasinglewell-characterizedgenomicbackground(GM24385),andorthogonallyvalidatedwithNGStechnology.

ThisspecificctDNACompleteproducthasanallelefrequencyof5%.

• 25uniquemultiplexedvariantsin16genes,covering12SNVs,7INDELs,3CNVs,and3SVs,inpurifiedandplasma-likematrixformats

• 6differentallelefrequencies(AF)–WT,0.1%,0.5%,1%,2.5%and5%

• Allowsend-to-endevaluationofassayperformanceacrosstheentireworkflow,includingpre-analyticextractionsteps

• VariantsquantitatedwithdigitalPCRandorthogonallyvalidatedbyNGS

• Blendswithwell-characterizedGM24385humangenomicDNAasbackground‘wild-type’material

• ManufacturedwithincGMPcompliant,ISO9001andISO13485certifiedfacilities

SeraCare的Seraseq™体细胞癌产品组合可通过设计和制造类似患者的参考材料来实现临床基因组学的前景，这些参考材料可用于开发，验证和实施分子下一代测序（NGS）分析，以支持临床评估和癌症疾病的管理。