Emphasis on personalized and precision medicines is driving partnerships between pharmaceutical and diagnostic organizations to develop companion diagnostics, with the goal of accelerating clinical trials and regulatory approval. The Personalized Medicine Coalition reports that personalized medicines topped 42% of approvals in 2018, doubling from 21% in 2014.


By definition a companion diagnostic is an in vitro device that provides critical information that can predetermine the safe and effective use of an established therapeutic in three ways.

  • Identify patients that will have optimal beneficial response to the drug
  • Identify patients that will not respond or may be at risk for the drug and should not receive treatment
  • Monitor responses to drug treatment for the purpose of adjusting treatment to potentially improve safety or effectiveness.

In our estimation, approximately one-third of early phase, oncology studies that NeoGenomics bids on either have a CDx already identified, or an assay that may be used as a CDx in later phases of development.

Because companion diagnostics are regulated devices, there are additional development requirements beyond those for biomarker or clinical assays used in clinical trials. Careful consideration must be given to the regulatory strategy, design of the assay and supporting technology platform to ensure that the device can be successfully commercialized. As a Global organization, NeoGenomics is powerfully sourced with strong clinical and scientific expertise in multiple biomarker technologies that can develop, initiate and deliver companion diagnostic programs worldwide from clinical trials all the way through commercialization

Experience

Our customers include 14 of the top 20 oncology drug companies.

As of January 2020, NeoGenomics to date has participated in more than 70 companion diagnostic (CDx) projects, developing and deploying a diagnostic test to select and enroll patients in a clinical trial. These cover a broad range of technologies and platforms. Of these projects, NeoGenomics typically has approximately 30 active programs at any given time, most of which are early stage projects using laboratory developed tests (LDTs) or repurposed in vitro diagnostic (IVD) kits for patient selection. NeoGenomics has additionally supported several pivotal CDx studies as a central testing laboratory. We have extensive experience with assay development, transfer, and analytical validation across a broad range of technologies.

Technology Count
FISH5
IHC48
ISH3
NGS3
PCR11
Sanger1
Nanostring1
Grand Total72
Technology Count Pie Chart

NeoGenoimcs can support multiple commercialization pathways for CDx development and approval. Most commonly, we are partnered with an IVD manufacturer to bring a test to market. Recent examples include the Agilent PDL1 test for NSCLC, Thermo Fisher's OncomineTM, Qiagen's PIK3CA test for Novartis' Piqray®, and Abbott's CLL Vysis kit. Additionally, NeoGenomics can support single-site FDA approved tests, including Premarket Approval (PMA) submission projects and humanitarian use device (HUD) projects, with two projects currently underway.

Our position as the leading oncology reference laboratory in the United States, and our ability to support assay development from inception through commercialization, makes NeoGenomics an ideal partner for diagnostic development. Our Day One Launch (link to DOL page) program ensures access to your CDx for the US market immediately following FDA approval.


CDx Experience

>30 ongoing CDx-related trials

Early-phase LDTs to late- stage regulated IVDs

Experience with 70+ CDx Programs

FISH (5), IHC (48), ISH (3), NGS (3), PCR (11), Sanger (1), Nanostring (1)

CDx Platforms

Molecular

Archer, Thermo Fisher, Illumina, ABI, Nanostring, Abbott, Biomerieux

IHC/ISH/FISH

Abbott, Agilent, ACD, Leica, Ventana

Up and Coming

Flow Cytometry

Multiplex IF

CDx Commercialization

LDT → ssPMA

LDT or HDE

Partner with IVD

Distributable kit

Day One Launch Program

Commercial Access


Case Study 1: PDL1 Launch with an IVD Partner

  • NeoGenomics selected as a PDL1/IHC testing site by Merck due to previous pathology expertise
  • Participated in early PDL1 validation program in support of Keytruda studies
  • PDL1 IHC clinical testing site in support of pivotal trials in partnership with Agilent
  • Launch of PDL1 testing immediately following FDA approval
  • NeoGenomics is currently the leading provider of PDL1 testing in the United States

Case Study 2: Re-purpose IVD kit for early phase development

  • Emerging pharma client developing a targeted therapeutic
  • NeoGenomics repurposed and re-validated an existing FDA-approved kit to support Phase 1-2 development
  • Project transitioned back to IVD manufacturer for Phase 3 development to support IUO kit manufacturing and PMA filing

Case Study 3: Transitioning from LDT to IVD Kit

  • Emerging pharma client developing a targeted therapeutic with an associated IHC-based CDx assay
  • IHC assay transferred to Neo as an LDT for early stage
  • Validated for use on IVD-capable equipment
  • Assay transferred to major IHC IVD manufacturer for support of late stage development, IUO kit manufacture, and eventual commercialization

Case Study 4: HUD Project

  • Emerging pharma client developing a targeted therapeutic
  • Requirement for CDx determined during late phase development
  • Economics of an ultra-rare patient population makes commercialization of the CDx assay as distributable IVD kit difficult
  • NeoGenomics supported testing in the Phase 3 study while simultaneously validating the assay to CDx-grade
  • HUD/HDE Regulatory filings with the FDA are underway for a single site approval with completion expected in 2020