The science is ready. Let's make sure the market is too.
EvidenceDx Consulting is a fractional commercial strategy practice built exclusively for clinical diagnostics. We embed senior commercial expertise where early-stage companies need it most — market strategy, KOL development, reimbursement, and launch execution — at a fraction of the cost of a full-time executive
Consulting Offerings
Every engagement is built around one goal: getting your diagnostic to the clinicians and patients who need it.
Commercial 360º Dossier
A comprehensive, academically-grounded deep-dive into your commercial landscape — built to sharpen your strategy, validate your market position, and give investors the confidence that your path to revenue is real and defensible.
Project Sprint
Targeted, time-bound engagements built around a single commercial priority. Defined scope, clear deliverables, fast execution — without the overhead of a long-term commitment.
Fractional VP Commercial
Embedded fractional leadership — strategic and executional — without the cost or commitment of a full-time executive. Ideal for companies building commercial momentum and needing a steady hand at the wheel.
About EvidenceDx
EvidenceDx Consulting was founded by Karla Gonye, MBA — a clinical diagnostics commercialization expert with 20+ years of experience across pharma, biotech, and diagnostic innovation, including 30+ product launches spanning oncology, nephrology, cardiology, infectious disease, rare neurological disorders, and women's health.
Karla has spent her career working with exciting new technologies that helped define this space — NGS, PCR, ELISA, mass spectrometry, T2MR, and targeted oncology platforms — and understanding not just what they do, but how to position them in a way that drives clinical adoption and sustainable revenue growth. That depth of technical and commercial fluency is what EvidenceDx brings to every engagement.
She has worked closely with co-founders and leadership teams at early-stage diagnostic startups, helping translate scientific vision into commercial reality — from first market entry through clinical adoption and investor-ready growth strategy. That founder partnership experience is rare, and it shapes how EvidenceDx approaches every client relationship.
Beyond her commercial work, Karla was Founder and Past President of the Healthcare Businesswomen's Association, Boston Chapter — a reflection of her broader commitment to leadership and community in the life sciences.
At the heart of everything is a single conviction: that getting novel diagnostics into the hands of clinicians changes patient outcomes. That's what drives this work every day.
Latest Insights
Fractional VP Commercial — Maintaining Momentum Through a Leadership Transition
When a key commercial leader departed midway through a high-stakes launch, an early-stage oncology diagnostics company needed immediate experienced leadership with no learning curve. Over five months I served as embedded fractional commercial lead — managing a major pharmaceutical strategic partnership, keeping commercial execution and a parallel FDA approval pathway moving in tandem, directing PR and communications, and representing the company at key medical conferences. The product launched on time, the partnership remained strong, and investor confidence was strengthened through one of the company's most challenging periods.
Project Sprint — Launch-Ready in Record Time
An early-stage biotech company approaching its US soft launch had no GTM strategy, no market-ready materials, and a business development team unprepared for a crowded oncology diagnostic market. I developed a dual-track GTM strategy, created a full suite of launch materials on a rapid turnaround, built a social media calendar, led KOL engagement strategy, and designed a competitive training program for the BD team. The company entered the US market on schedule — polished, credible, and ready to compete.
Commercial 360° Dossier — Case Study Coming Soon
Currently completing our inaugural Dossier engagement with an early-stage stealth diagnostics company. Results will be published here upon completion. Interested before then? Let's talk.
CASE STUDIES