Reference Lab Testing

Zepto FungiFlex® Reference Test

Direct from plasma cfDNA based organism identification for invasive fungal diseases, results in less than 24 hours after sample receipt.

Sample submission

Ordering providers collect a single plasma sample and submit it to Zepto’s CLIA reference laboratory with a completed test requisition form.

Shipping

Zepto Life Technology
Attn: Reference Lab
1000 Westgate Drive, Suite 2000
St. Paul, MN 55114
United States
Refernce Lab Contact Number+1 (651) 504-6873

New client inquiries

Setting up a new sending facility? Reach out to our CLIA lab team to get started.

Emailinfo.clialab@zeptolife.com

Established in 2020

For the past six years, Zepto Life Technology's high-complexity CLIA laboratory team has been committed to expanding access to molecular testing and improving turnaround times, giving clinicians the clarity they need, earlier.

Wei Wang, Ph.D.
VP of Regulatory

Doctor Wang is Vice President of CRO and Regulatory at Zepto Life Technology, where he has worked for over a decade. He holds a Ph.D. from Nanjing University and brings more than 15 years in IVD assay development, leading Zepto's CLIA laboratory, CRO services, and FDA regulatory submissions.

Wen-Wei Chung, Ph.D.
Laboratory Director

Doctor Chung is the Laboratory Medical Director of Central Regional Pathology Laboratory in Maplewood, MN. He earned his medical degree from National Yang-Ming Medical University in Taipei, Taiwan, along with a Ph.D. in Developmental Neuroscience, and completed combined anatomic and clinical pathology training at the University of Pittsburgh Medical Center.

How FungiFlex® works

01

cfDNA extraction

Extraction optimized for recovery of short-fragment, low-abundance cell-free DNA from plasma.

02

PCR Amplification

Amplifies pathogen-specific regions for every panel target in a single reaction.

03

Exonuclease digestion

Selective digestion removes one DNA strand, leaving probe-ready single-stranded DNA.

04

GMR detection

ssDNA binds its pathogen-specific probe on the multi-sensor array for magnetic readout.

Why FungiFlex®?

Directly from plasma

Obtain organism-level information from a simple blood sample—without waiting for culture or invasive specimen collection.

Results when time matters

Results reported in < 24 hours after sample receipt, helping support earlier treatment decisions when invasive fungal infection is suspected.

Targeted for the clinical question

Purpose-built to detect clinically important fungal pathogens rather than everything—providing focused information when fungal infection is on the differential diagnosis.

Organism identification that informs treatment

Reports clinically relevant fungal pathogens directly from plasma, providing actionable organism-level information to help guide antifungal therapy.

Designed for the point of suspicion

Designed to provide clinically useful information early in the diagnostic workup, when invasive fungal infection is first suspected.

A growing fungal testing menu

Available today through Zepto's CLIA-certified reference laboratory with a growing menu of targeted fungal assays.

Frequently Asked Questions

FungiFlex® is a family of targeted plasma cell-free DNA (cfDNA) liquid biopsy tests designed to detect clinically important fungal pathogens directly from a blood sample. Testing is performed through Zepto Life Technology's CLIA-certified reference laboratory.

Choose the test based on your clinical question:

  • FungiFlex® Mold Panel — Detection of invasive mold pathogens.
  • FungiFlex® Pneumocystis jirovecii — Targeted detection of P. jirovecii.
  • FungiFlex® Mold Plus — Combined detection of invasive molds and P. jirovecii.

FungiFlex® is intended for patients in whom invasive fungal infection is part of the differential diagnosis, including transplant recipients, oncology patients, individuals receiving immunosuppressive therapy, and other immunocompromised patients.

Plasma sample collected from k2EDTA whole blood (purple top).

Each FungiFlex® assay targets a defined group of clinically important fungal pathogens.

Results are reported in less than 24 hours after sample receipt at Zepto's CLIA-certified laboratory.

FungiFlex® is a targeted fungal assay designed for situations where invasive fungal infection is suspected. By focusing on clinically important fungal pathogens, the test provides rapid, targeted organism-level identification to support timely clinical decision-making.

Yes.

Positive results identify the detected fungal pathogen (or pathogen group, depending on the organism), providing clinically useful organism-level information that may help guide antifungal therapy.

No.

FungiFlex® is currently offered as a Laboratory Developed Test (LDT) through Zepto Life Technology's CLIA-certified laboratory.

The FungiFlex® assays are currently available through Zepto's reference laboratory. Development of the Zepto MDx™ integrated platform is underway.

Ready to order, or have a question?

Reach out about ordering FungiFlex®, clinical questions, or getting set up as a new client!

INFO.CLIALAB@ZEPTOLIFE.COM · +1 (651) 504-6873