Core Diagnostics located in Hayward, California is a full-service esoteric pathology laboratory with molecular diagnostic capabilities for pre-clinical and clinical research projects. Our capabilities include gene expression analysis (low and high-throughput PCR) on nucleic acid isolated from FFPE samples using both Fluidigm platform and NanoString technology. In addition we offer pathology, histology, immunohistochemistry and FISH assay services.
The CLIA certified laboratory conducts screening of clinical samples for assays developed internally or by a biotech/pharma client, analyzing both pre-clinical and Phase I to III clinical trial samples for customers. Our research laboratory works with clients to develop specialized assays and incorporate unique technology needs working as a seamless extension of the clients team.
Our unique capabilities include access to a sub-specialty expert panel of pathologists. Core Diagnostics is superbly positioned as a premier provider of biomarker discovery and assay services with state of the art laboratory facilities, an experienced management team and collaborations in place with technology vendors to be a partner from discovery through commercialization.
We develop molecular cytogenetic strategies for client projects, including developing novel FISH probes for their projects. We develop, optimize and validate novel and routine FISH assays and create scoring guidelines for these assays to be used for their projects. In partnership with Advanced Cell Diagnostics, we offer RNA in-situ hybridization assays in our CLIA laboratory including detection of both coding and non-coding RNA’s. Our state of the art AllegroTM fluorescent imaging system makes capture and transfer of images to clients easy and seamless.
We develop, test and validate custom protocols using new or already established antibodies for our clients employing open IHC platforms. Our assay development and validation studies are guided by resident board certified pathologists. We provide IHC services for analysis of research and clinical trial samples in our CLIA laboratory with protocols transferred from a client or developed in-house. Our pathologists develop scoring guidelines and review slides routinely.
Our expertise in pathologist directed recovery of nucleic acid from frozen and FFPE samples by macro dissection of tumors from slides enables us to provide nucleic acid for analysis with multiple technologies including RT-PCR, NGS and Nanostring, in addition to performing paraffin embedding, sectioning, H&E staining and pathology review of tumor samples.
We are trained and experienced in offering all Nanostring services including Gene Expression Assay Panels, Elements Technology, mIRNA, CNV, Single Cell Expression and RNA:Protein Assays.
We develop molecular strategies for client projects by designing and executing assays for mutational analysis. The technologies used include real-time PCR (Taqman, SYBR and other chemistries) and Sanger sequencing of amplified nucleic acid. Our expertise in pathologist directed recovery of nucleic acid from frozen and FFPE samples by macro dissection of tumors from slides enables us to use multiple platforms for identifying and characterizing mutations. In addition to developing and optimizing RealTime-PCR assays for individual client needs, the availability of our BioMarkTM HD and nCounterR Systems makes it possible to conduct high-throughput mutational analysis of research and clinical trial samples.
Employing both, standard RT-PCR (the BioMarkTM HD) and new cutting edge hybrid capture technology (nCounterR) platforms from Fluidigm and NanoStringR respectively, we offer solutions for high-throughput gene expression needs for our clients. The high-throughput capabilities of the nCounterR and the BioMarkTM HD System allow for rapid expression analysis of hundreds of genes from thousands of samples. These technologies combined with our expertise in isolating nucleic acid from tumor areas of FFPE sections delineated by our pathologists, allows us to readily analyze large numbers of clinical trial samples for our clients. The complementary technologies of Nanostring’s digital quantification of nucleic acids based on color-coded barcodes and Fluidigm’s nanolitre volume RT-PCR reactions driven by a microfluidics platform can also be used for gene fusion analysis, SNP genotyping, and copy number variation. In addition, we also provide services for developing and validating gene expression assays for low though-put studies on our ABI real-time PCR systems.
Laboratory and Facility Management Services
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