A Paradigm
Shift in Point-of-Care
Respiratory Assessment
Rapid differentiation between Bacterial vs Non-Bacterial Infections

Fingerstick Point-of-Care Test

Results in 10-15 Minutes

FDA Cleared

NPV to Rule Out Bacterial Infection¹

Supports Antibiotic Stewardship

Supports Urgent Care and ER Workflows
How FebriDx® Works
FebriDx uses a proprietary combination of two host immune response biomarkers CRP and MxA to aid clinicians in distinguishing bacterial infection from non-bacterial etiology at the point of care.

CRP (C-Reactive Protein)
CRP is an acute-phase inflammatory protein that rises in response to infection and systemic inflammation. It elevates rapidly within hours of infection and reflects the severity of the inflammatory response, but alone remains non-specific for bacterial infection at lower thresholds.

MxA (Myxovirus Resistance Protein A)
Individually, CRP and MxA are insufficient to differentiate bacterial from non-bacterial illness.
Together, they provide the clinical sensitivity and specificity needed to support respiratory decision-making.
By combining a marker of systemic inflammation (CRP) with a virus-specific immune marker (MxA), FebriDx delivers actionable insight into the underlying immune response driving acute respiratory illness¹.
Backed by Peer-Reviewed Evidence
Annals of Medicine
18 Apr 2018
Published in 18 May 2018
A prospective, multi-centre US clinical trial to determine accuracy of FebriDx point-of-care testing for acute upper respiratory infections with and without a confirmed fever
Shapiro, N. I., Self, W. H., Rosen, J., Sharp, S. C., Filbin, M. R., Hou, P. C., Sambursky, R.
Conclusion
Open Forum Infectious Diseases
2017 Nov 3
Published in 2018 Feb
Outpatient Antibiotic Stewardship: A Growing Frontier—Combining Myxovirus Resistance Protein A With Other Biomarkers to Improve Antibiotic Use
Joseph P, Godofsky E.
Conclusion
Journal of Clinical Medicine
14 Aug 2017
Published in 7 October 2017
Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections
Self, W.H.; Rosen, J.; Sharp, S.C.; Filbin, M.R.; Hou, P.C.; Parekh, A.D.; Kurz, M.C.; Shapiro, N.I.











Supporting
Antibiotic Stewardship
In acute respiratory care, lack of real-time diagnostic clarity often leads to unnecessary antibiotic prescribing.
FebriDx addresses that gap by providing rapid immune-response insight at the point of care , supporting more confident, evidence-aligned treatment decisions.
Multiple peer-reviewed studies demonstrate that FebriDx-guided management can:
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Reduce
Reduce unnecessary antibiotic use when bacterial infection is unlikely². -
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Improve
Improve clinician confidence in treatment decisions². -
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Support
Support stewardship initiatives across urgent care and emergency settings².
Demonstrated Economic Value in Acute Respiratory Care
Beyond clinical impact, published health economic models suggest FebriDx-guided care may significantly reduce the overall cost burden of acute respiratory infections (ARIs).
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~$8.25 billion
Estimated annual U.S. cost of ARI management under standard-of-care³. -
2
~$5.74 billion
Estimated cost with FebriDx-guided management³. -
3
~$2.5 billion
Potential annual system-wide savings³.
Sensitivity analysis (changing assumptions within ±20%) showed the potential savings ranged from as low as US $0.08 billion to as high as US $3.27 billion, indicating savings persist across a range of plausible scenarios, but depend on key variables like test sensitivity, prevalence, and population size³.
Empowered by compassion
Enhancing health through care
At Healer, we are committed to providing exceptional healthcare that prioritizes patient well-being. Our experienced team works collaboratively to create personalized treatment plans that cater to individual needs.
Empowering you with expert care and personalized support to take control of your well-being every step of the way.
Medical consult
Expert medical advice tailored to your needs.
Medical records
Secure and seamless access to your health data anytime.
Emergency help
Fast and reliable support in urgent medical situations.
Pharmacy care
Easy and reliable access to essential medications.
Order Through Dx Direct Today.
Dx Direct is built to eliminate the operational, administrative, and adoption barriers that slow down point-of-care innovation, helping clinical teams evaluate, implement, and use FebriDx confidently in real-world care settings.
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Before You Order: Clinical & Operational Confidence
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At the Point of Purchase: Speed & Simplicity
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After Go-Live: Ongoing Support That Actually Matters
Why Providers Choose Dx Direct?

Authorized & Preferred Distribution Partner
Direct alignment with Lumos Diagnostics — no gray market risk, no uncertainty

Dedicated FebriDx
Focus
Not a catalog reseller. One product. One mission. Deep expertise.

Low-Friction
Ordering
Streamlined purchasing designed for urgent care, EDs, and outpatient workflows

Subscription & Volume-Aligned Pricing
Predictable supply, reduced reordering burden, discounted pricing for committed usage

Education-First Support
Clear clinical context, onboarding guidance, and implementation support

Reimbursement & Documentation Resources
Practical support to help teams navigate billing and internal justification
We’re more comfortable not prescribing antibiotics when the test supports it. It helps align our decisions with stewardship goals without slowing down care.
Dr. Anjali Patel, DO
Urgent Care Physician
Having a tangible result makes conversations with patients much easier. It’s no longer just an explanation — we can show them why antibiotics aren’t needed.
Dr. James Reynolds, MD
Emergency Medicine Physician
Implementation was straightforward. Training was minimal, and our staff were comfortable using it quickly.
Lisa Gomez, RN
Clinic Manager
It’s easy to find a vendor. It’s much harder to find a team that actually helps when you’re using something day-to-day. Dx Medical Solution has been consistently available when we’ve needed guidance.
Jason Miller
Operations Manager, Urgent Care Group
One of the biggest benefits has been how it changes patient conversations. When we can show a result, patients better understand the decision, and there’s noticeably less pushback around antibiotics.
Dr. Steven Morales, MD
Urgent Care Physician
“
FebriDx provides a
tangible, visual result
that clinicians can
share during
the visit.
”
tangible, visual result
that clinicians can
share during
the visit. ”
By the numbers
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Loyal clients
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Patients treated
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Years
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Patients treated
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Wellness starts
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Community reach
Step-by-step
Clear steps to get started now
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Personalized care
We tailor treatment plans to each patient’s unique health needs for the best outcomes. -
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Advanced technology
Our clinic uses cutting-edge equipment and techniques for accurate diagnosis and effective treatment. -
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Experienced specialist
Our skilled medical team brings years of expertise to provide top-quality healthcare.
Common questions
Frequently asked questions
01 Is FebriDx FDA approved?
FebriDx is FDA cleared, It is cleared for use by healthcare professionals to support clinical decision-making in acute respiratory infections. Learn More about FDA Clearance here
02 What does FebriDx actually measure?
FebriDx measures the host immune response, not a specific pathogen, using two biomarkers:
- MxA → associated with viral infection
- CRP → associated with bacterial infection
03 Does FebriDx diagnose infection or replace clinical judgment?
No. FebriDx is not a standalone diagnostic and does not replace clinical judgment.
Results should always be interpreted in the context of clinical signs, symptoms, and patient history.
04 How long does it take to get results?
Results are available in approximately 10–15 minutes, while the patient is still in the room.
05 How is the sample collected?
FebriDx uses a simple fingerstick capillary blood sample. No venipuncture. No lab send-out.
06 Is this only for pulmonologists or respiratory specialists?
No. FebriDx is designed for front-line acute care, including:
- Urgent care
- Emergency departments
- Primary care and outpatient respiratory assessment
07 How does FebriDx support antibiotic stewardship?
By helping differentiate bacterial vs non-bacterial immune responses, FebriDx can support more confident treatment decisions and reduce unnecessary antibiotic use when bacterial infection is unlikely.
08 Does FebriDx detect COVID, flu, RSV, or other pathogens?
No. FebriDx does not detect specific pathogens. It evaluates the body’s immune response, which is a different clinical question.
09 Can FebriDx be used in pediatric patients?
Yes. FebriDx has been studied in pediatric emergency settings and has demonstrated clinical utility in supporting antibiotic decision-making in children with febrile acute respiratory infections.(12-60)
10 How do we order FebriDx?
FebriDx can be ordered directly through Dx Direct, the preferred and dedicated Lumos Diagnostics partner, offering fast ordering, reliable delivery, and ongoing support.
11 Does Dx Direct provide reimbursement support?
Dx Direct provides reimbursement support resources and guidance, but does not guarantee reimbursement. Coverage and payment are subject to payer policies.
12 What if CRP is elevated due to chronic or non-infectious conditions?
FebriDx uses a CRP threshold of ≥20 mg/L to help minimize low-level, non-specific inflammation. However, CRP can be elevated in some non-infectious conditions, which is why FebriDx results must always be interpreted in the context of clinical history and examination.
13 What is the reimbursement rate for FebriDx?
FebriDx is listed on the CMS Clinical Laboratory Fee Schedule (CLFS) with a national reimbursement rate of $41.38 per test.
14 Can FebriDx be used in pediatric patients?
FebriDx is FDA cleared for patients aged 12–60 years and has demonstrated clinical utility in adolescent acute care settings when used alongside clinical judgment.
15 What is the storage requirement of FebriDx?
FebriDx tests can be stored at room temperature (4-25°C or 39-77°F).
16 What is the ideal timing for using FebriDx?
The test is most appropriate when: Symptoms have been present for 7 days or less The patient is within 3 days of fever onset This timing aligns with the expected immune-response window for the biomarkers measured by FebriDx and supports more reliable clinical interpretation.
17 Is training required?
FebriDx is designed for ease of use by trained healthcare professionals. Dx Direct provides education and implementation support to ensure smooth adoption
18 What is the CPT Code for FebriDx ?
The CPT (Current Procedural Terminology) PLA (Proprietary Laboratory Analyses) code for the FebriDx test is 0442U
Clinical Operations Journal
by Dx Direct
FDA Approved vs. FDA Cleared: Understanding the Key Difference You Need to Know
Have inquiries? Reach out to us!
References
[1] Shapiro, N. I. et al. (2018) ‘A prospective, multi-centre US clinical trial to determine accuracy of FebriDx point-of-care testing for acute upper respiratory infections with and without a confirmed fever’, Annals of Medicine, 50(5), pp. 420–429. doi: 10.1080/07853890.2018.1474002.
[2] Wilcox, Christopher R et al. “Use of the FebriDx® host-response point-of-care test may reduce antibiotic use for respiratory tract infections in primary care: a mixed-methods feasibility study.” The Journal of antimicrobial chemotherapy vol. 79,6 (2024): 1441-1449. doi:10.1093/jac/dkae127
[3] Dick, Katherine, and John Schneider. “Economic Evaluation of FebriDx®: A Novel Rapid, Point-of-Care Test for Differentiation of Viral versus Bacterial Acute Respiratory Infection in the United States.” Journal of health economics and outcomes research vol. 8,2 56-62. 30 Sep. 2021, doi:10.36469/001c.27753
