Issuing Body American Association for Laboratory Accreditation
Issuing Body Country UNITED STATES OF AMERICA
Issuing Body Website https://www.a2la.org/
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Eurofins CellTx is dedicated to offer testing support for living donor derived source material: stem cell, bone marrow, cord blood, birth tissues, egg and sperm donations. The laboratory’s extensive testing menu supports safety, quality and function of these cells from donor source to transplantable cell-based products, regenerative medicines and fertility applications.
Issuing Body American Association for Laboratory Accreditation
Issuing Body Country UNITED STATES OF AMERICA
Issuing Body Website https://www.a2la.org/
Issuing Body California Department of Public Health
Issuing Body Country US - United States
Issuing Body Website https://www.cdph.ca.gov
Issuing Body Maryland Health Department
Issuing Body Country US - United States
Issuing Body Website https://health.maryland.gov
Issuing Body New York State Department of Health Wadsworth
Issuing Body Country US - United States
Issuing Body Website https://www.wadsworth.org/regulatory/clep
Issuing Body Pennsylvania Department of Health
Issuing Body Country US - United States
Issuing Body Website https://www.pa.gov/agencies/health
Issuing Body State of Rhode Island Department of Health
Issuing Body Country US - United States
Issuing Body Website https://health.ri.gov/
Issuing Body West Virginia Department of Health
Issuing Body Country US - United States
Issuing Body Website https://bph.wv.gov/
Eurofins CellTx is a trusted provider of specialized testing services for cell therapy, tissue transplantation, fertility, and regenerative medicine programs. As part of the global Eurofins network, we combine scientific expertise, regulatory knowledge, and a commitment to quality to support clients throughout the donor screening and product testing lifecycle.
Our comprehensive service offerings include FDA donor eligibility testing, infectious disease screening, microbiology testing, fertility testing, and customized laboratory solutions designed to meet the evolving needs of healthcare and life science organizations.
With a focus on accuracy, responsiveness, and exceptional client service, Eurofins CellTx delivers reliable results and rapid turnaround times that help clients make critical decisions with confidence. We are dedicated to advancing patient safety and supporting innovation in reproductive medicine, cell therapy, tissue banking, and transplantation.
Scientific Excellence. Trusted Results. Responsive Service. That's the Eurofins CellTx commitment.
Ready to get started?
Due to the critical nature of Eurofins CellTx's work, it is imperative that back-up systems are in place to ensure continuity of business. Eurofins CellTx has a robust business continuity plan.
Eurofins CellTx's IT infrastructure is deployed via Azure Cloud. The platform has been deployed to full backup and disaster recovery capability. Eurofins CellTx also maintains two sources for internet services which are networked for redundancy purposes.
Eurofins CellTx maintains a dual feed electrical system and utilizes uninterruptible power supply for all critical equipment. All critical equipment is also duplicated which allows for maintenance and equipment repair.
Eurofins CellTx is part of the global network of Eurofins Clinical Diagnostics laboratories. In the unlikely event of a disaster, rendering the Tucson, AZ location incapable of performing testing, Eurofins CellTx is partnered with Eurofins DPT as a back-up testing facility for key protocol redundancies. Eurofins CellTx and Eurofins DPT also share a centralized Laboratory Information Management System that is connected via a bi-directional interface for data exchange as required.
Eurofins CellTx's partnership with the University of Arizona Technology Park (UA Tech Park) is essential to our carbon neutrality goals. UA Tech Park's commitment to the environment was key to choosing the location of our state-of-the-art facility.
Why we chose to locate at the UA Tech Park
Eurofins CellTx supports the local science ecosystem of Arizona by supporting the local universities and STEM and STEAM programs through educational and mentorship programs for future scientists, by being an active member of the AZBio organization and by fostering collaboration and innovation with other organizations based at the University of Arizona Technology Park.
Eurofins CellTx embraces a Quality Management System that adheres to regulatory requirements, applies clients’ expectations, and fosters a culture of continual improvement.
Brenna Guzman, Regulatory Affairs and Quality Assurance Manager
Ronnie Aga leads Eurofins CellTx as the Eurofins Legal Entity President and General Manager. As an original co-founder of VRL HCT/P Laboratories, Ronnie has executed several roles in donor testing and leadership since 1991. Ronnie believes the core business of Eurofins CellTx starts and ends with the customer. It should be an extension of our clients’ mission and care takers of the wish to donate life saving and enhancing human tissues.
Mano has over 14 years of experience in a highly regulated transplant testing laboratory focused on Infectious Disease Testing and Laboratory Operations. For the past few years, he served as the Infectious Disease Director and Specialty Molecular Director for CellTx sister lab, Eurofins DPT. As a respected leader in his field, he was responsible for developing best lab practices and brought dynamic teams together, post-acquisition and merge of Eurofins VRL and LABS Inc. He has a Doctor of Medicine degree with an undergraduate Bachelor of Science degree majoring in Biology from the Lyceum Northwestern University, Philippines.
Brenna oversees the regulatory framework and quality systems for CellTx. Brenna has worked in a regulated environment since 2004 including Human Cell and Tissue Product manufacturing and medical device. Her regulatory and quality assurance experience includes CLIA, AABB Standards, 21 CFR 1271, ISO 9001:2015, ISO 13485:2016, MDSAP, 21 CFR 820; and 21 CFR Part 11. Brenna is a proven leader and believes in maintaining a business wide culture of quality and works collaboratively to set the quality and regulatory strategic direction.
Dr. Bauer is board certified in Clinical Pathology and Transfusion Medicine. He served as a blood bank physician in Michigan, New Jersey, and Colorado. In 2000 he founded MJB Lab Consulting, his CLIA-qualified laboratory consulting practice. He earned his MD and completed his residency in pathology at the Loma Linda University School of Medicine in 1997. His fellowship was in Blood Banking and Transfusion Medicine at Cedars-Sinai Medical Center in Los Angeles.
The Eurofins CellTx test menu continues to expand, delivering insights into living cell safety, quality, and function as medicine evolves from static diagnostics to cell-based decision-making.
FDA Donor Testing with Rapid Turnaround Times
When donor eligibility decisions can't wait, Eurofins CellTx delivers FDA donor testing with the speed, quality, and reliability your program depends on. Our comprehensive infectious disease testing services support donor screening requirements while helping fertility clinics, tissue establishments, and cell and biotherapy therapy programs stay on schedule.
With rapid turnaround times, expert scientific support, and a commitment to quality, we provide timely results that help accelerate donor qualification and minimize delays in treatment and product release. Trust Eurofins CellTx for responsive testing solutions that keep your program moving forward with confidence.
Fast Results. Trusted Quality. Reliable Partner.
Contact our team to learn more about our rapid FDA donor testing services.
Additional NAAT Assays for Cell and Biotherapy Donors with Rapid TAT
Our experienced microbiology team delivers accurate, reliable testing to support tissue establishments and cell and biotherapy programs. By understanding pre-disinfection contamination levels, clients can make informed decisions, validate cleaning and disinfection procedures, and strengthen quality assurance programs. A full suite of additional microbiology product testing is currently offered through Eurofins DPT.
Protecting Patients, Donors, and Reproductive Outcomes
Pre-screen infectious disease testing is a critical component of fertility and reproductive medicine. Whether you are a sperm donor, intended parent, fertility clinic, or reproductive tissue bank, comprehensive infectious disease screening helps ensure the safety of reproductive materials and supports compliance with applicable regulatory and clinical requirements.
At Eurofins CellTx, we provide reliable, high-quality infectious disease testing services designed to support fertility programs with accurate and timely results.
Comprehensive Testing Services
We offer testing for key infectious disease markers commonly required for fertility and donor screening programs, including:
Viral Diseases:
SpermQT is a peer-reviewed, proprietary, patent protected epigenetic sperm assay that analyzes the sperm’s genes to measure its ability to find, bind, penetrate, and fertilize an egg SpermQT analyzes the dysregulation in the DNA methylation patterns of 1,200+ genes that are essential for sperm function. The higher the number of dysregulated genes, the lower the quality of the sperm. Based on this measure, SpermQT categorizes the sperm sample as Excellent, Normal, or Abnormal quality.
Get a clear, clinical picture of your sperm health with Complete Semen Analysis. We measure key factors like sperm count, concentration, motility, and morphology. Designed for convenience without compromising accuracy.
You can check your sperm count from the comfort of your home with an at-home sperm check test. All you need to do is provide the semen sample.
Eurofins CellTx test menu, LabPort, sample collection network, international testing, licenses and registrations, and donor eligibility tests.
Use the link below to access the Eurofins CellTx test menu.
Use the link below to access our client portal, Eurofins LabPort.
Expanding Access Beyond Traditional Patient Service Centers
Through our partnership with My One Medical Source (MOMS), Eurofins CellTx offers access to a nationwide network of more than 2,000 collection locations, providing convenient donor specimen collection services across the United States.
Designed to support fertility clinics, sperm and egg donor programs, cell and biotherapy donors, and reproductive health organizations, our collection network helps eliminate geographic barriers and simplifies the donor testing process. Donors can complete required collections at conveniently located healthcare facilities, reducing travel time and improving participation and compliance.
By combining specialized FDA donor testing expertise with a broad physical collection footprint, Eurofins CellTx delivers a compelling alternative to traditional laboratory patient service center networks. The result is greater flexibility, improved donor access, and a seamless testing experience for both clinics and donors.
Benefits include:
Specialized Donor Testing. National Collection Access. One Trusted Partner.
Eurofins CellTx specializes in supporting donor testing programs on a global scale. With experience managing donor collections from more than 50 countries across 6 continents, we have the expertise, infrastructure, and logistical capabilities to coordinate complex international donor testing requirements.
Our team works closely with clinics, donor agencies, reproductive programs, and collection facilities worldwide to ensure compliant specimen collection, efficient transportation, and seamless testing coordination. Whether supporting directed donors, reproductive donor programs, or international fertility patients, we help simplify the challenges of global donor management.
Our global capabilities include:
| License | Expiration |
| A2LA Clinical Testing | 04/20/2027 |
| CA License | 03/14/2027 |
| CLIA Certificate | 06/01/2027 |
| FDA Registration | Non-Expiring |
| Maryland Laboratory Permit | Non-Expiring |
| Pennsylvania Permit | 08/15/2026 |
| Rhode Island License | 12/30/2026 |
| West Virginia License | 12/31/2026 |
| New York License | 06/30/2026 |
| ISO 15189:2022 | 04/20/2027 |
| cGMP | 06/01/2027 |
| Analyte and package insert | Method | Test kit name | Manufacturer | Test type | FDAlicensed, approved, or cleared for donor screening |
CE Mark |
| HIV 1/2 Antibody | Automated/Manual | Elecsys HIV Duo | Roche Diagnostics | Screening | Yes | Yes |
| Hepatitis B Surface Antigen | Automated/Manual | Elecsys HBsAg IIand HBsAg II Auto Confirm | Roche Diagnostics | Screening | Yes | Yes |
| Hepatitis B Core Antibody | Automated/Manual | Elecsys Anti-HBc II | Roche Diagnostics | Screening | Yes | Yes |
| Hepatitis C Antibody | Automated/Manual | Elecsys Anti-HCV II | Roche Diagnostics | Screening | Yes | Yes |
| HTLV I/II Antibody | Automated/Manual | Elecsys HTLV-I/II | Roche Diagnostics | Screening | Yes | Yes |
| Syphilis Non-Treponemal RPR | Automated | ASI Automated RPR | Arlington Scientific, Inc. | Screening | Yes | Yes |
| Syphilis Treponemal CAPTIA-G | Manual | CAPTIA-G | Trinity BioTech | Screening | Yes | Yes |
| Elecsys Syphilis | Automated | Elecsys Syphilis | Roche Diagnostics | Screening | Yes | Yes |
| CMV Antibody | Automated/Manual | Elecsys Anti-CMV | Roche Diagnostics | Screening | Yes | Yes |
| NAT HIV-1/2, HCV & HBV | Automated | Procleix Ultrio Elite Assay Panther | Grifols | Screening | Yes | Yes |
| NAT - WNV | Automated | Procleix WNV Assay Panther | Grifols | Screening | Yes | Yes |
| Chagas | Automated | Elecsys Chagas | Roche Diagnostics | Screening | Yes | Yes |
| Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) | Automated | GEN-PROBE® Aptima Combo 2® Assay | Hologic | Detection | * 510K K180681 | No |
*Although there are diagnostic tests available, there are currently no FDA-licensed, approved, or cleared tests for donor screening. In the absence of such screening tests, you must use an FDA-licensed, approved, or cleared diagnostic test labeled for the detection of these organisms in an asymptomatic, low-prevalence population (§ 1271.80(c)). The use of Chlamydia trachomatis and Neisseria gonorrhoeae tests utilizing NAT technology adequately and appropriately reduces the risk of transmission of these relevant communicable disease agents (§ 1271.80(c)).