Academic · Early-stage · Late-stage
Bring us a great idea from any setting. We work with you to build and execute a complete commercialization plan, from assay development and optimization through the right regulatory path, coding, coverage and reimbursement, and market access.
From idea to revenue
Many promising tests never reach patients. The science works, but the path to a reimbursed, commercially available test is long and easy to get wrong: the wrong regulatory route, evidence that payers will not accept, or a lab and supply chain that cannot scale.
ResearchDx brings development, validation, regulatory, reimbursement and laboratory operations under one roof, so every decision is made with the end market in mind.
300+
new assays validated since 2015
Millions
of tests performed for clients in the US and internationally
15+ years
taking assays from concept to market
Any starting point
We step in at any stage, assess what you have, and build the plan from there.
Academic
You have
A published biomarker, a promising dataset, or a research-grade assay in a university lab
We help you
Define the intended use and market, transfer the assay, and build a development plan investors and partners can follow
Early-stage
You have
A prototype assay with early performance data and a company or program behind it
We help you
Optimize for real-world specimens, lock the design, choose the regulatory path and plan the evidence payers will need
Late-stage
You have
A validated or nearly validated test, or a program that has hit a regulatory, reimbursement or scale-up wall
We help you
Close the gaps, launch in a CLIA laboratory or as a kit, and secure coding, coverage and payment
Your commercialization plan
Review your science, data, intended use and competitive landscape, and identify the gaps between where you are and a commercial test.
Optimize the assay for real-world specimens, workflow and cost of goods, so it performs at scale and not just in the lab.
Decide between an LDT, an FDA-cleared or approved IVD, or an LDT first with an IVD to follow, based on your market, timeline and budget.
Analytical and clinical validation to CLIA/CAP or FDA standards, designed so the data also support coverage decisions.
Secure billing codes, payer coverage and pricing, and set up billing so claims are paid.
Launch from our CLIA-certified, CAP-accredited laboratory or yours, or as an ISO 13485-manufactured kit, and support growth after launch.
LDT · IVD
The path you choose shapes your timeline, your costs, who can run your test and how it is paid for. We help you choose it early, and build so you can change course later.
LDT
Best for
Getting to patients quickly, with testing performed in a single CLIA-certified laboratory
What it involves
CLIA and CAP validation, state licensure where required, and a laboratory to run the test, ours or yours
IVD
Best for
Distributing a test to other laboratories or the point of care
What it involves
Design controls, ISO 13485 manufacturing, analytical and clinical studies, and a 510(k), De Novo or PMA submission
LDT → IVD
Best for
Generating revenue and real-world evidence while an FDA submission is prepared
What it involves
An LDT built to FDA expectations from day one, so validation data and documentation carry into the submission
Coding, coverage and reimbursement
Reimbursement is planned alongside development, not after launch. We identify the coding, coverage and pricing route for your test, and design validation and clinical studies to produce the evidence payers and Medicare contractors expect.
We then prepare and support the applications, and set up billing so your laboratory can submit claims from day one.
CPT and PLA code applications
MolDX technical assessments
DEX Z-Code registration
Medicare coverage (LCD) strategy
Clinical Laboratory Fee Schedule pricing
ADLT applications
Billing and claims setup
Market access
Market access is more than a launch date. We help you reach clinicians, payers and partner laboratories, and keep the test competitive after launch.
Clinical validity and clinical utility studies designed to answer the questions payers and clinicians ask.
Offer your test from PacificDx, our CLIA-certified, CAP-accredited laboratory, or set up a laboratory of your own.
ISO 13485 and GMP-compliant kit manufacturing, from pilot lots to production, plus collection and shipping kits.
Transfer a validated assay to your laboratory or a partner laboratory, with training and documentation.
Post-launch quality, assay updates, new specimen types and claims, and the evidence for expanded coverage.
Tell us where your assay is today and where you want it to go. We’ll recommend a commercialization path and plan.