With known development and regulatory expertise, NeoGenomics has created a defined processes associated with each aspect of development that involves coordinated efforts in the areas of Consultation; Customization; Commercialization; and Consolidation. Development of companion diagnostics is complex and time-consuming. Our team of scientists, pathologists, and business development professionals are here to help.
Technology agnostics platform selection
CDx study design
Pathology expertise across multiple disciplines
Scientific expertise across multiple technology platforms
De novo assay development
Global harmonization of custom assays across multiple testing sites
Project, data, and regulatory management
NeoGenomics is the largest oncology-focused laboratory in the USA
Established relationships with major IVD providers
Single site FDA-approved test approvals and partnerships for Ex-USA launch
Day One Launch program
Sponsored Testing programs
Consolidate CDx and specialty testing with one CRO
Our position as the leading oncology reference laboratory in the United States makes NeoGenomics an ideal partner for CDx development. We have supported more than 90 CDx track projects, developing and deploying assays covering a broad range of technologies and platforms. NeoGenomics has extensive experience with assay development, transfer, and analytical validations in support of pre-clinical through Phase III drug development.
NeoGenomics has >120 MDs and PhDs across a broad range of medical and scientific expertise to guide assay development, analytical validation, and commercial development. Our development philosophy is to reduce risk by aligning early on with CDx commercialization goals whether it be for a single site FDA-approved test or a global distributable kit.
Biomarker assays that are intended for development as a CDx (prototype CDx) are generally referred to as a Clinical Trial Assay (CTA). We draw upon best practices found in FDA Guidances, CAP or CLIA guidelines, industry groups such as the Clinical Laboratory Standards Institute, advice from our IVD partners, as well as previous CDx approvals. NeoGenomics provides three options for development, validation, and deployment of a CTA:
A laboratory developed test (LDT) is developed and validated fit-for-purpose within NeoGenomics. This is the most popular option for earlyphase drug development programs because of low cost and shorter development timelines relative to an IVD kit. NeoGenomics will select a platform and appropriate reagents that are required for CDx development, manufacturing, and eventual regulatory approval. At a later stage, the assay can be bridged to an IVD kit or developed as an FDA-approved single site assay.
- Existing IVD Kit
An existing IVD kit is an ideal solution, if it exists, as it presents an optimized assay and an established pathway to regulatory approval and commercialization. IVD kits can be validated fit-for-purpose to support early phase development of your drug, and then passed back to the manufacturer for support of pivotal Phase 3 studies and regulatory approval.
- Custom Manufactured IVD Kit
A collaboration with an IVD partner to develop and manufacture an IVD kit is typically pursued for later-phase development. NeoGenomics has experience working with all major oncology IVD manufacturers and use of research-grade or investigational use only (IUO)-grade assays.
NeoGenomics can support the following platforms for CDx development. We also offer multiple FDA-cleared diagnostics that can be utilized for orthogonal accuracy studies. Our list of assays and platforms is constantly being updated, so please reach out directly to NeoGenomics for the most current options.
Anatomic Pathology (IHC and ISH)
- Ventana Benchmark Ultra XT
- Lecia Bond III (Bond Rx also available for research-grade projects)
- Agilent Dako Link 48
- Agilent Omnis
- Abbott Vysis
- Agilent IQFISH
- Illumina MiSeq, HiSeq, NextSeq, and NovaSeq
- Thermo Fisher Ion Torrent
- Thermo Fisher QuantStudio 7
- ABI 3500 and ABI 3730
- Nanostring Flex Dx
- Roche Cobas 4800
- Qiagen RotorGene RGQ
- BioCartis Idylla
- Beckman Coulter Navios 10-color
- Beckton Dickinson Fortessa 16-color
- Akoya Polaris 6-plex
- Nanostring GeoMx DSP
Single Site FDA Approved Tests
NeoGenomics offers multiple options for development of single site FDA-approved tests. This approach now dominates the majority of new approvals from the FDA. The choice of a distributed IVD kit versus single site test is complex and multifactorial. Our team of experts is here to provide guidance.
NeoHeme® NGS Panel
The NeoHeme CDx is a 302-gene NGS panel with broad applicability for myeloid and lymphoid neoplasms for comprehensive diagnostic, prognostic, and therapeutic reporting. The assay was developed and validated under design control and is currently onboarding new CDx-track projects in anticipation of future FDA approvals.
Whole Exome Sequencing NGS Panel
NeoGenomics has developed a whole exome sequencing (WES) assay intended as a comprehensive ssPMA CDx platform for solid tumors. The assay is CLIA-validated and is being used to support multiple pharma programs, including CDx-track studies. NeoGenomics is currently onboarding new CDx-track pharma projects in anticipation of future FDA approvals
NeoGenomics can additionally develop individual single site tests on multiple platforms including immunohistochemistry, molecular technologies, flow cytometry, and multiplexed immunofluorescence.
Companion Diagnostic tests are regulated devices. Careful oversight to ensure compliance with Federal Regulations and development according to agency guidelines is required for a successful marketing application.
Our regulatory and quality teams are an integral part of all CDx projects. Regulatory works closely with our scientific and medical teams to ensure that assays are sufficiently analytically validated for their intended use. Additionally, the NeoGenomics Regulatory Affairs group can support the following submissions and interactions with the Food and Drug Administration.
- Risk assessments
- Pre-submission meetings with CDRH
- IDE filings
- PMA filings
- HUD and HDE filings
Our laboratory licenses and accreditations can be found here.
NeoGenomics has been operating for over two decades and is the largest oncology-focused clinical reference laboratory in the United States serving >650,000 patients and running more than one million diagnostic tests annually (2019 data). We are one of the few CROs that offer integrated testing for clinical trials and commercial launch for the United States.
Our commercial team of more than 100 sales professionals, covering oncologists, pathologists, hospitals, and private payer groups ensures ease-of-access for ordering physicians. NeoGenomics has developed several programs and approaches to assist with CDx adoption and utilization by physicians.
Day One Launch
If NeoGenomics participates in the pivotal clinical trials for your diagnostic as a central testing site, we can readily support Day One CDx Launch for the US market immediately following FDA approval. The CDx test will be added to our menu of clinical services, and our sales force trained on appropriate use. We make it easy for physicians to order companion diagnostic testing.
Click below for a case study of our Day One Launch for Qiagen’s Therascreen PIK3CA RGQ PCR test to support the launch of Novartis’ PIQRAY® therapeutic.
Sponsored Testing Programs
Uncertainties regarding reimbursement can significantly hamper the adoption of diagnostic testing for patient management. NeoGenomics has developed a Sponsored Testing Program to eliminate this.
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