Mary Meeker and Amplion Analysis

March 2017 Safety Biomarkers and Pharmacovigilance Webinar

Fail Early, Fail Fast - And Increase Likelihood-of-Approval

The First Ever Blood Biomarker For Multiple Sclerosis Discovered.

Top Blog Posts of 2016

Biomarkers and The Adoption Cycle: Where are we now?

Chart of the Week: Phase 3 LOA Vs Biomarker Coverage Percent

October Webinar - Improving Your Biomarker Intelligence

Chart of the Week: Phase 3 LOA Vs Precision Medicine Score

Biomarker Intelligence Management - Process (Part 2 of 5)

Chart of the Week: Missed Biomarker Information Without Comprehensive Synonyms

Chart of the Week: Percent Decrease in Curation Time with BiomarkerBase

Chart of the Week: Literature Review: Time Spent on Irrelevant Results

Chart of the Week: September is Alzheimer's Month

What we’ve learned about effective biomarker knowledge management

Chart of the Week: Pharma Trials Using Selection Biomarkers

Chart of the Week: 3x Improvement in Likelihood of Approval

Chart of the Week: Liquid Biopsy Focused on Lung Cancer

Chart of the Week: Cost of Biomarker Information

Liquid Biopsy in Precision Medicine Webinar

Chart of the Week: National Psoriasis Awareness Month

Chart of the Week: Rare Disease Activity Sample (LSDs)

Chart of the Week: Bladder Cancer Awareness Day

Chart of the Week: Can Liquid Biopsy Screen for Disease?

FDA Regulation to Support the Next Wave in Diagnostics

Chart of the Week: FDA Approved Multiplex Diagnostics Growing

Precision Medicine Focus: Psychiatric Biomarkers

Chart of the Week: Hepatitis C - Gilead Wins

LDT Companies Out-Perform IVD Companies

Chart of the Week: Value Network of Healthcare

Dx Test Developers Experience Declining Revenue Growth

Chart of the Week: Panels Emerging, Single Biomarker Tests Dominate

Chart of the Week: Biopharma Players in Alzheimers

Companion Diagnostics Play a Confusing Role with PD-1 Inhibitors

We collaborated with BIO and Informa on a ground-breaking study

New Releases Do Little to Clarify FDA's Definition of Complementary Diagnostics

Chart of the Week: Update: Unique Biomarkers in Pharma

Lawsuit a Catalyst for LDT Regulation Progress?

Chart of the Week: Alzheimer's Biomarker and Trial Landscape

Precision Medicine Innovation Not Just a Numbers Game

Chart of the Week: Celgene Precision Medicine Activities Graph

Biomarker Panels Explode in LDTs

Chart of the Week: Panel Opportunities in Lung Cancer

Precision Medicine Scorecard Revision: Novartis Leads The Way

Metabolic Biomarkers Dominate Companion Diagnostics

Tracking Biomarker Trends Still a Big Problem

Chart of the Week: Personalized Medicine Dependent on Time to Market

Chart of the Week: Innovative Biopharma = Faster Biomarkers to Trial

EUDAMED Access and LDT Uncertainty Threatens Personalized Medicine

Chart of the Week: Protein IVDs Flatline Nucleic Acid IVDs Explode

Chart of the Week: CDx Driving Biomarker Discovery - Bonus, Novelty

New white paper reveals how biomarkers contribute to the progress of Precision Medicine

Chart of the Week: The Race to the Biomarkers Tipping Point

CROs Identifying Business Opportunities with Biomarkers

Chart of the Week: Celgene Poised to Dominate Personalized Medicine?

Chart of the Week: Over 150 Companion Diagnostic Biomarkers in Current Development

Chart of the Week: Over 700 Unique Biomarkers in 2015 Clinical Trials

Chart of the Week: Huge Growth in Clinical Trials Involving Biomarkers

Unique Biomarkers Are Associated With More Drug Approvals

News From the Personalized Medicine World Conference: Platforms Dominate

Chart of the Week: Unique Biomarkers Used by Top Pharma

Chart of the Week: Algorithms Slow Test Review Period

[Infographic]: A Visual History of LDT Regulation

Chart of the Week: Test Approval - Experience Counts

Chart of the Week: Average Review Time for FDA Approved/Cleared Tests

10 Diagnostics Innovators: Smaller Companies Are Leading the Way

Variability in Reimbursed Amounts for Biomarker-Based IVD Tests

Is This a Big Opportunity for Diagnostic Test Developers?

FDA Finally Provides Better Evidence of LDT Risks

Personalized Medicine Pipelines: AstraZeneca, Genentech, and Novartis

Upcoming Congressional Hearing on Lab Test Regulation

CMS Plan for Test Pricing Seems to Favor Large Labs

Why Personalized Medicine Matters

Introducing the Personalized Medicine Scorecard™: Drug Companies Edition

73% Growth in the Use of Companion Diagnostic Biomarkers

Is Personalized Medicine Being Properly/Fully Utilized?

Two New Personalized Medicines Approved by FDA So Far in 2015

FDA Introduces a New Test Concept: "Complementary Diagnostics"

New Approaches To Identifying Targeted Therapeutics

Regulatory Delays Are Keeping the Diagnostics Industry in Limbo

Watson Tackles the Genomic Interpretation Gap

Where Are the Innovative Diagnostics Companies?

The Two Biggest Ideas for Personalized Medicine

CDx Breakdown Shows That Personalized Medicine is Gaining Ground

California Launches New Initiative to Integrate Statewide Healthcare Data

Logistics Present Yet Another Challenge for Clinical Genomics

Oncologists Struggle to Utilize Precision Medicine

FDA and CMS Have Formed a Joint Task Force for LDT Co-Regulation

Tackling Ovarian Cancer's Most Urgent Unmet Need: Ten Years and Counting for One Research Team

LDT Biomarker Panels: A First Look

Which Biomarkers Are Relevant? Making Sense of the "Incidentalome"

15 Years From Discovery To The Clinic

Documentation of Clinical Validation Inconsistently Provided by LDT Developers

FDA-Approved Biomarker Panels: The Good, The Bad, and The Ugly

Academic and Commercial Institutions Team Up to Enrich Variant Analysis

"As I lay dying" - A Powerful Personal Exhortation

Linking Data Silos is a Major Key to Clinical Genomics

Notes from the Personalized Medicine World Conference

Huge Growth in New Biomarkers During 2014

LDT Workshop Reveals New Insights

JAMA Publishes Pro/Con Opinions on LDT Regulation in Advance of FDA Workshop

BRCA1 and BRCA2 Now Validated for Companion Diagnostic Use

House Committee Seeks Feedback on LDT Regulation

FDA Approves Blinatumomab for Acute Lymphoblastic Leukemia

Margaret Hamburg (FDA) Measures Progress in Personalized Medicine; Describes Database-Driven Test Review

LDT Regulation: The Plot Thickens

Having More Biomarker Professionals Correlates With More Revenue per Employee Overall

NY-ESO-1, An Emerging Biomarker for Ovarian Cancer

Google is Developing a Nanoparticle System for Biomarker Detection

Is Ovarian Cancer Under-Served by Personalized Medicine?

Oxford University Makes Huge Investment in Personalized Medicine

U.S. Behind the Curve in RAS Mutation Testing

New Revelations from Congressional Hearing on LDT Regulation

Personalized Medicine Gains Traction

FDA's Draft Guidance on LDT Regulation Released In Full, Plus Guidance on Notification

Video of Congressional Hearing on LDTs Posted Online; FDA Defends Regulatory Authority

Congressional Subcommittee Hears Testimony on LDTs

AACR Affirms Its Support For FDA Regulation Of High Risk LDTs, But Is There Proof of Harm? Ovasure Doesn't Seem to Provide It.

European Medicines Agency Publishes Concept Paper on Biomarker Best Practices

Prognostic Applications Are Growing Rapidly for Cancer Biomarkers

The Personalized Medicine Coalition Has Issued Its Fourth State of the Industry Report

There Has Been a Surge in New Biomarkers During 2014

Draft Guidance for LDTs Has Finally Been Released

Survey About Personalized Medicine Shows Low Public Awareness

Based on Recent Trends, FDA Regulation of LDTs Could Certainly Adversely Affect Biomarker Test Innovation

10 Biomarkers to Watch in Metabolic and Endocrinology

LDT Regulation is Coming to a Head: Lab Directors Send Letter to OMB Urging Rejection of FDA Draft Guidance

Increased Clinical Trial Speed, and Decreased Adverse Events, Primary Drivers in Personalized Medicine

Mining Clinical Trials for Marketing and Product Development Opportunities

Senators Urge OMB to Release FDA's Draft Guidance on LDTs

10 Biomarkers to Watch in Cardiovascular

10 Biomarkers to Watch in Oncology

Biomarkers In Clinical Trials: 80% Are Used In Two Or More Therapeutic Areas

Clinical Trials Are Increasingly Using Multi-Biomarker Approaches

Industry Report: Using Biomarkers To Accelerate Clinical Development

Genetic Testing Is Becoming More Routine At Cancer Hospitals

Companies That Entered The Biomarker-Based IVD Market For The First Time During 2013

NanoString Inks $45 million CDx Collaboration With Celgene

Roche Leads The Way In Biomarker-Based Test Releases

IVD Developer Vermillion Opens CLIA Lab

IVD vs LDT Market Comparison:Key Findings

Part 2. IVDs: A Market Perspective

Part 1. LDTs: A Market Perspective

AstraZeneca Reveals All; Provides Detailed Support for Biomarker Use In Clinical Trials

Biomarkers and Commercial Strategy: Comparing The Three Leading Breast Cancer Panels

Multi-Biomarker Tests Dominated 2013 FDA Clearances

FDA-Cleared Biomarker Tests Are On The Upswing

Market-based Reimbursement Provisions for Lab Tests Passes Senate with Industry Backing (GenomeWeb)

Biomarkers in Clinical Trials:A 2013 Snapshot

Biomarkers Increase Clinical Trial Success Rates by Over 100%

510(k) Review Periods Shortening for Biomarker Tests

23andMe Case Highlights Regulatory Ambiguity

FDA Report: "Paving the Way for Personalized Medicine"

Biomarkers Market Exceeds 25 Billion: Kalorama Report

Qiagen receives FDA approval for EGFR mutation test

Medicare Punts on Establishing Dx Reimbursement

EGFR Mutation Testing Rates in Canada Increased with Financial Support

LDT for Thyroid Cancer Now Reimbursed for Over 110 Million Patients

Post Mortem for Pathwork Diagnostics

LDTs Clearly Remain Troublesome for FDA

Myriad's True Value

Reporting rates for clinical trials

CDx Partnership Bears Fruit with New FDA-Approved Test

Predictive Biosciences Has Closed Due To Validation Requirement (Burrill Report article)

Assay patenting instead of gene patenting to support diagnostic test development

Barrier to Adoption: Uncertainty About Sample Requirements

In Cancer Treatment, New DNA Tools -

Translational research: Crossing the valley of death : Nature News

Who will fund the next generation of diagnostic tests?

Diagnostic Errors Are the Most Common Type of Medical Mistake

Mathematical models out-perform doctors in predicting cancer patients responses to treatment

Post Mortem for a Diagnostics Company by a Founding Investor

Genetic Analysis is Already a Commodity Product

Doing it Right, part 3

Doing it Right, part 2

Doing it Right, part 1

Doing it Wrong

Testing Rates Seem to Be Low for Psychiatric Drug Metabolism

Treating Toe Fungus Increases Sudden Death Risk for Some Schizophrenics: A Case Study in Biomarker Awareness

Personalized Medicine: Rate of Advancement and Key Variables Affecting Same

Bowel Cancer Testing Rates Low in UK, High in France

Should psychiatrists be testing their patients for drug response?




Pharmacovigilance and Safety Biomarkers

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