As the largest oncology-focused clinical reference laboratory in the United States, NeoGenomics is an ideal commercial partner. We are one of the few CROs that offers integrated testing for clinical trials and commercial launch for the United States.
NeoGenomics clinical reference laboratory covers more than 650,000 patients and providing more than one million diagnostic tests in 2019. With more than 15 years of experience providing oncology testing, and the scientific and clinical expertise from more than 120 PhDs and MDs, our team has more commercial launch experience than any other specialty laboratory. Our sales team of more than 100 individuals, covering oncologists, pathologists, hospitals, and private payer groups ensures ease-of-access for ordering physicians.
Even with an FDA-approved CDx developed, there is no guarantee of commercial success and widespread adoption in the US market. An assay that works well in clinical trials may not be readily adopted by physicians or commercial laboratories. A widely-utilized CDx is essential for the commercial success of your drug. NeoGenomics has developed several programs and approaches to assist with CDx adoption and utilization by physicians. We are here to ensure the success of your test, from inception in preclinical, to successful deployment in clinical practice.
Day One Launch
NeoGenomics can support Day One Launch in the United States. If NeoGenomics participates in the pivotal clinical trials for your diagnostic as a central testing site, we can readily support 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. As a full-service oncology laboratory, NeoGenomics can support all aspects of patient management, from diagnostic confirmation, and additional molecular diagnostic and prognostic testing required as part of standard cancer care. We make it easy for physicians to order companion diagnostic testing.
NeoGenomics recently launched the FDA-approved PIK3CA test to support launch of Novartis’ PIQRAY® therapeutic.
Sponsored Test Programs
Uncertainties regarding reimbursement can significantly hamper adoption of diagnostic testing for patient management. NeoGenomics has developed a Sponsored Test Program to eliminate this barrier to utilization and ensure that all decisions on patient care are based on the best available medical science.
Under this program, the Pharma Sponsor provides payment for CDx testing services so that eligible patients may be tested by their oncologist free-of-charge.
NeoGenomics has initiated two Sponsored test programs underway
Healthcare Information Services
As the largest oncology-focused full service laboratory in the United States, NeoGenomics has access to high quality data to accelerate clinical trial enrollment and physician outreach services.
Patient & Site Selection
Profile Patient cohorts
Identify potentially eligible patients
Medical team outreach to ordering physician
Determine level of interest and connect to trial sponsor
Sponsor provides physician with enrollment options
Please visit our Oncology Data Services page to learn more
Lab Developed Tests when a CDx is not available
Targeted drugs are not always developed in parallel with their CDx. Recent examples include microsatellite instability (MSI) for MSI-high cancers for Keytruda® and NTRK fusions or mutations for Vitrakvi®. In these instances, NeoGenomics can partner with drug developers to ensure that a well- validated and robust laboratory developed test is available to support commercial launch. Physicians can utilize this assay until the appropriate CDx is approved.
Following the approval of Vitrakvi, NeoGenomics partners with Bayer to ensure availability of laboratory-developed tests (LDTs) for NTRK fusions to support commercial launch through a sponsored testing program.