Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

So Many Posters, So Little Time

Have You Seen Our Latest Scientific Poster Presentation Videos?

Newly Published Multi-Laboratory Study Provides Utility and Validation of the Use of ctDNA Reference Standards

Making the Shift from Technological Innovation to Operational Excellence: Delivering on the Promise Of Next-Generation Sequencing for Personalized Medicine

Precision Medicine and Clinical Labs: AACR Dinner Seminar Recap

Presenting NTRK Reference Materials for Global Assay Standardization at AACR 2019

AACR 2019 Day Three: Understanding T-cell Therapy for Unique Cancer Mutations

AACR 2019 Day Two: Learning About the Microbiome in Immuno-Oncology

AACR 2019 Day One Highlights: Next-Generation Car T Cells

New Podcast: Target the Tumor Mutational Burden and Pursue Harmonization

A Featured Speaker Podcast by Friends of Cancer Research

Video: See How an EQA Improves Clinical Genomics Testing with Affordable Custom Reference Standards

Ground Control to Major Tom: Use Controls and Keep Your Assay Running On

The Full Authority Companion Diagnostic

Customer Data: Use of Seraseq ctDNA Reference Samples to Validate Detection of Low Frequency Variants in a cfDNA-based NGS Lung Cancer Panel

NTRK Fusion Testing for New Therapies

Detecting & Managing Rare Pediatric & Adult Cancers

Keys to Better Liquid Biopsy Assay Sensitivity – AMP Corporate Workshop Video

Tips for Better EGFR Mutation Testing

Workshop Video: Two Experts Take on Clinical Genomics QC and Standardization at AMP

Two Must-See Liquid Biopsy Poster Videos From AMP 2018

The Trouble with Troubleshooting Clinical NGS

Building and Implementing Liquid Biopsy Assays with the Industry’s Most Patient-Like Reference Materials

To Realize the Potential of Liquid Biopsies, Focus on Higher Quality Research and Clinical Data Sets

Keep Calm and Standardize On

A Panel of Experts Discusses Best Practices for Clinical NGS Quality Management in the Rapidly Evolving Field of Clinical Genomics

Are You Ready to Take the “Red Pill” and Enter a World of Standardized Clinical NGS Assays?

As Immunotherapy Use Rises, Critical Gaps Remain in Harmonizing Tumor Mutational Burden Measurements

A consortium of industry experts has combined forces to solve TMB challenges.

cccDNA and HBV:  New Testing Methods May Allow for Earlier, Non-Invasive Detection of Hepatocellular Carcinoma

If I Call Out of Tune, Would Mutations Stand Up and Walk Out on Me?

Microsatellite Instability Testing to Predict Immunotherapeutic Response: New Tools to Meet Testing Challenges

A First of its Kind Survey to Assess the QC Habits of Labs Running Clinical NGS Assays

Developing a Rock-Solid Lung Cancer Assay, Part 2

Ebola Outbreak 2018: Diagnostics Again are Essential to Minimize Spread and to Control Disease

How A New Generation of ctDNA Reference Standards Are Enabling the Promise of Precision Medicine

FAQ: What to do when your NGS assay fails to detect a variant contained in Seraseq Reference Materials?

Sensitive ctDNA Assays are Required for Minimal Residual Cancer Detection

Twists and Turns That Lead From “Curiosity Driven Research” To Innovative Diagnostics

Next-Generation QC Precision Metrics for Next-Generation Sequencing

Introducing the SeraCare Confidence Score, a comprehensive precision metric designed for NGS assays

What Is The Difference Between Quality Control Software Like iQ NGS And LIMS?

Developing a Rock-Solid Lung Cancer Assay

An Efficient and Ultrasensitive NGS Solution for Profiling ctDNA [Poster Talk Video]

CNVs and Tumor Profiling: New CNV Materials for Breast, Lung, and Brain Cancer

Reliable Interpretation of NGS Data: New Poster Talk Video

With so many options, how do you select the best NGS cancer assay?

How am I going to test my assay? Should I use patient samples or biosynthetic materials?

AMP Reference Material Forum: Themes and Highlights

Higher Quality for Better QC

As to Myeloid Diseases, Make a Habit of Three Things

Use genetic information to treat, or at least to diagnose and to predict

3 Steps for Building a Bulletproof Clinical NGS Assay: Step 3

We’ve already covered the first two steps. In this article, we’ll look at the third one. Choosing the right reference material technology can help control the high validation and running costs of highly multiplexed assays.

AMP 2017 Highlights: The Epigenetic Basis of Common Human Disease

3 Steps for Building a Bulletproof Clinical NGS Assay: Step 2

Because NGS assays are so complex, involving a dizzying number of genes, mutation types, and options for sequencing and bioinformatics, the bulletproof assay is no easy feat. But it can be done.

The First Comprehensive Myeloid Cancer Reference Materials for NGS Assays

Evaluate your detection of key diagnostic, prognostic, and therapeutic markers

3 Steps for Building a Bulletproof Clinical NGS Assay: Step 1

What do we mean by bulletproof? A bulletproof NGS assay is one that exhibits the highest performance and reliability in delivering patient results. If you want every assay your lab develops to be bulletproof, read on.

Clinical NGS Assay Developers: Eliminate Your Specimen Search Headaches

A New Focus on Implementing Clinical Genomics

This is the Number One Risk to Your Clinical Sequencing Assay

Critical missteps during the assay development phase can cause expensive delays and risk the quality of an assay. How can you be sure your bioinformatics pipeline is correctly calling variants?

Is Your NGS-Based Assay on the Right TRK?

From extraction, to library prep, to sequencing, to the bioinformatics pipeline, there are countless points where something could go wrong.

Expert opinions on LDT transparency and standardization

You can’t validate everything… can you?

Rapid and Early detection of Listeria to prevent food poisoning

Accelerating Liquid Biopsy Assay Development

Session Summary from Next Generation Dx Summit 2017

Does your NGS lab struggle with quality control? [Free Guide]

Three liquid biopsy problems solved by the most patient-like ctDNA reference materials

SeraCare’s new Seraseq™ Circulating Tumor Reference Materials

What specifically contributes to high levels of NGS accuracy?

Insight from the 2017 Precision Medicine World Conference

Get Out of QC Spreadsheet Agony

iQ™ NGS QC Management software for easy assessment of assay performance

Dr. Andrea Ferreira-Gonzalez on the Seven Benefits of Clinical Genomics Universal Standardization

The Chair of Molecular Diagnostics, Department of Pathology at Virginia Commonwealth University shares her success story

How Many Target Copies Are Present in Your Plasma DNA Sample?

A 0.1% measurement requires a reasonable amount of input material

2 Ways to Be Sure Your Clinical Laboratory-Developed Test Results Are Correct

How do I know my NGS-based LDT is producing the right results? And how do my results compare with others running similar tests?

Real-World Needs for Genetic Testing Reference Materials

From troublesome mutations to FDA validation studies

How to Validate Your Lab’s Clinical Genomics Tests Affordably … and Revalidate

For clinical genomics testing laboratories, validation — and to a certain extent, revalidation — is a fact of life. 

Improve the Reliability of Your Zika Diagnostic Assays

Robust molecular and serology reference materials for Zika diagnostic assays

Futureproof Your Clinical Genomics Lab’s Compliance: 3 Tips to Prepare for Potential Requirements

3 Tips for Reducing the Costs of Running Your Clinical Genomics Lab (While Maintaining Accuracy and Efficiency)

Your Lab Is Growing; Here’s How to Train Your New Staff Quickly

Do remnant patient samples perform well enough to train new laboratory personnel quickly and assess their proficiency?

Prevent Assay Drift In Your Clinical NGS Assay by Avoiding 2 Common Mistakes

Daily variations in your test performance can cause assay failure and may lead to false positives. Do you have the tools to detect them?

3 Root Causes of Downtime for Clinical Genomic Testing Labs (and How to Recover Fast)

Patients Can't Afford to Wait for Their Test Results

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