Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Extracting Formalin-fixed, paraffin-embedded (FFPE) nucleic acids for NGS

Answering frequently asked questions (FAQs)

Highlights from the Precision Medicine World Congress

Status of FDA regulation of laboratory developed tests, the promise of precision medicine, and a workshop about achieving accurate NGS laboratory test results

Introducing A New Reference Material for KRAS Molecular Testing

Seraseq FFPE Tumor KRAS Reference Material Kit

Multiplexed Reference Materials as Controls for Cardiomyopathy Diagnostic Next-Generation Sequencing

A Journal for Molecular Diagnostics article describing ‘an attractive addition to the repertoire of materials for the development, validation, and quality monitoring of clinical NGS assays’

Clinical Laboratories: You Are Not Alone. (Part II)

"The most effective ways to use QC data to monitor the health of your NGS assay."

Clinical Laboratories: You Are Not Alone.

“Ensure NGS-based tests for Personalized Medicine are safe and effective for guiding medical management decisions”

Reference Materials for Your Unique Reproducibility Needs

The distinction between accuracy and precision.

What lessons for liquid biopsy have been learned from fetal aneuploidy testing?

FDA-AACR Liquid Biopsies in Oncology Drug and Device Workshop

Important information for assay development and review by the FDA

IVD Guidance for NGS Manufacturers

Mary-Claire King at the European Society for Human Genetics 2016

Her vision of genomic medicine as a dialogue at ESHG 2016 in Barcelona, Spain

SeraCare introduces AccuPlex™ Zika Reference Material

Recombinant viral technology to assist development of PCR-based Zika Virus diagnostic assays

American Association for Cancer Research 2016 ctDNA highlights

Circulating tumor DNA, along with immunotherapy, are two major themes of #AACR16

Previewing the American Association for Cancer Research 2016 Conference #AACR16

The premier cancer research conference heads to the New Orleans Convention Center April 17 - 20, 2016

The FDA NGS-based Oncology Panels Workshop

Impressions from the first FDA workshop focusing on NGS-based oncology diagnostic tests

Circulating Tumor DNA Reference Materials

The Seraseq Circulating Tumor DNA-I Reference Materials officially launches, as well as a Circulating Tumor DNA-I Mutation Mix

Highlights from the 2016 Molecular Medicine Tri-Conference

Diagnosing inherited disease, processing FFPE samples, state-of-the-art oncology in North Carolina, and developments in circulating tumor DNA technology

Molecular Tri-Conference Preview (San Francisco CA March 7-11 2016)

A molecular medicine, drug discovery and diagnostics conference recognizing the potential of new technologies and their role in mitigating disease and identifying transformative treatments

Oncology Regulatory Framework for NGS Webinar Friday Feb 26 2016

A webinar co-sponsored by TOMA Biosciences, Intermountain Health and SeraCare

Circulating Tumor DNA Poster at Keystone Symposium

Poster Titled “New Technical Approach to Construct ctDNA Materials for use in Characterizing, Developing and Validating Plasma Assays”, available for download

Does synthetic DNA sequence behave the same as cell-line DNA?

Performance analysis of SeraCare’s Seraseq Solid Tumor Mutation Mix-I AF10 and AF20

Analytical Validation using Biosynthetic Mutation Targets

Recent NCI publication for validation of a targeted NGS assay for treatment assignment in the NCI-MPACT trial

LDT Oversight Counterpoint: Tempering FDA Arguments

Counterpoint to the FDA arguments for laboratory-developed test oversight

Newsworthy Science in 2015

Three major themes in 2015 from SeraCare

LDT Oversight: Why the FDA makes a point

Laboratory-developed tests are in the spotlight by the US Food and Drug Administration

Sanger versus Next-Generation Sequencing Infographic

A handy infographic to compare the first-generation (Sanger) and next-generation sequencing (NGS) technologies

The current state of non-invasive prenatal testing

A personal story of an expectant father intersects with the complex problem of testing specificity and sensitivity

Video Interview: Developing Aneuploidy Reference Materials

Interview with Dr. Seth Harkins, Principal R&D Scientist

What is Non-Invasive Prenatal Testing (NIPT)?

A brief review of fetal aneuploidy testing

Association for Molecular Pathology 2015 Conference Highlights

Two presentations of note from the 2015 AMP Conference, Austin Texas #AMP2015

Posters from AMP 2015 Available for Download

The 2015 Association for Molecular Pathology (Austin TX) posters about Reference material stabilization technology, recombinant virus, fetal trisomy patient-like material, and somatic tumor mutation profiling.

Circulating tumor DNA liquid biopsy needs reference standards

How can you measure something without a ruler?

Association of Molecular Pathology Meeting Nov 4-7 2015

With the theme "Realizing the Promise of Precision Medicine" in Austin, Texas

Video: What are the sources of variability in FFPE material?

Interview with Dr. Greg Tsongalis, Professor of Pathology, Dartmouth-Hitchcock Medical Center

Genetic Profiling of Pediatric Oncology Patients

Recent publication highlights potential of personalized medicine for young cancer patients

Precision Medicine Perspective

Interview with Condie Carmack, Ph.D. Vice President Translational Medicine, GenomOncology

What is Precision Medicine?

Video Interview: Why use reference materials for precision medicine?

Are you wondering why reference materials are needed for precision medicine?

Introducing SeraCare’s Genomic Precision Blog

SeraCare, Precision Medicine and You


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