VDx Preclinical Research
Our Goal
Our goal at VDx is to help you obtain the most meaningful and reliable results from your research studies from start to finish, whether it be protocol and methods development, necropsy support, histology processing, or comprehensive evaluation and data analysis.
Since 2001, the VDx Preclinical Research team takes pride in providing our clients in the medical device, biotechnology, and pharmaceutical industries with the highest quality full-service histopathology support. Our laboratory is fully compliant with FDA Good Laboratory Practices (GLP), and we have supported our clients on over 350 GLP studies.
Why choose VDx?
Comprehensive Reporting
Collaborative Approach to Research
Exceptional Customer Service
Experience
Study Flow Overview
1. Schedule a Consultation
- Discuss goals & scope of study
- Provide tailored support on study logistics
- Meet our team!
2. Structure Your Project
- Establish a Research Account
- Review NDA/CDA
- Provide support on study design, models & feasibility
3. Estimate & Statement of Work
- Estimate proposal
- Confirm agreement
- Establish a Statement of Work (SOW)
4. Study Scheduling & Finalization
- Finalize SOW, study timeline & deliverables
- Formally schedule study & services
5. Project Execution!
- Provide necropsy support & study oversight
- Share progress updates
Schedule a Consultation
Discuss goals & scope of study
Provide tailored support on study logistics
Meet our team!
Structure Your Project
Establish a Research Account
Review NDA/CDA
Provide support on study design, models & feasibility
Estimate & Statement of Work
Estimate proposal
Confirm agreement
Establish a Statement of Work (SOW)
Study Scheduling & Finalization
Finalize SOW, study timeline & deliverables
Formally schedule study & services
Project Execution!
Provide necropsy support & study oversight
Share progress updates
Outline of Services
Consultation & Necropsy Services
- Protocol, Methods Development, & Study Design
- Necropsy Support
- Study Coordination (including estimate and Statement of Work (SOW) preparation and scheduling of services)
GLP & Quality Assurance
Histology Services
Pathology & Reporting Services
Whole Slide Scanning
GLP Archive Preparation
Outline of Services FAQ
Can your pathologist perform our necropsy?
How do I submit my study samples to VDx?
Can I submit prepared slides or digital slides (whole slide images) for evaluation by a VDx pathologist?
I only need histology preparation for my study – can VDx help?
What histology staining do you provide?
What is “GLP”?
VDx Preclinical is fully compliant with FDA Good Laboratory Practices (GLPs), as detailed in CFR 21, part 58. Our laboratory has a full system of Standard Operating Procedures (SOPs) that facilitate the rigorous quality standards and consistent, repeatable methods necessary for a successful FDA study review. As such, we maintain an independent quality assurance unit (QAU) that monitors our facility processes and GLP studies in accordance with federal regulations. We are happy to host your management and / or Quality Assurance (QA) unit for an in-person test site visit. If you would like to conduct an audit of our facility, please contact us so that we may schedule a visit. Or, in lieu of visiting VDx, our QA unit can complete a desk audit and send you the results.
Help! I am not sure what histopathology support I need for my study
Don’t worry! Our team is experienced in providing protocol and methods development for our clients, and we are happy to work with your team and test facility contacts to facilitate the optimal histopathology work tailored for your study.
How much will my study cost?
We are happy to provide you with a cost estimate for your study! As every study is different in size, scope, and nature, please contact our Research Services Team and submit a Preclinical Study Cost Estimate form for review. We offer all new clients a complimentary 30-minute study consultation with our Research Services Team technical staff to discuss general study logistics (i.e., requested services, scheduling of necropsy / sample submission, study goals, etc.).
When will my project be completed?
During study scheduling, our team will provide you with a Statement of Work (SOW) outlining the scope of work to be performed, along with deadlines for deliverables (i.e., histology processing and / or reporting). As every study is different in size, scope, and nature, timelines for results may vary. Our goal with each study is to provide your team with our most competitive turnaround time while ensuring the highest quality results.
Can you expedite my study results?
In most cases, VDx can accommodate STAT turnaround times for specific study phases (i.e., histology processing and / or reporting) or all on-site VDx work. Please contact us to discuss STAT study availability, cost, and logistics.
Can your pathologist perform our necropsy(s)?
Yes!
Please contact us to discuss scheduling our team to attend and / or perform your necropsy(s). We work with many test facilities both locally in the Sacramento area, as well as across the state of California, and from coast to coast in the U.S.
How do I submit my study samples to VDx?
Sample Fixation & Packaging
Ensure the sample is appropriately fixed (12-24 hours) before shipment. Transfer the sample into a leak-proof container for shipment in a smaller volume of fixative to avoid spillage.
We recommend using jars/ containers (with tightened lids) or food-grade heat sealable bags. If utilizing a lidded container, use a flexible sealing film (such as Parafilm) if possible, to ensure a tight moisture-barrier.
Label the sample container with the following information (may vary):
– Study ID, Animal ID, Sample / Tissue
Sample Shipment
Ensure the contained sample is placed into secondary containment and additional absorbent material when placed into the shipping box.
- Double-line a box with two large, thick trash bags.
- Add absorbent material (such as puppy pads) to the inside of the bags at the bottom.
- Place the sample container(s) inside of the trash bags and tie them off tightly.
- If there is extra space in the box, we recommend adding additional packaging materials to prevent the sample container from shifting during shipment.
- If possible, please include a hard copy of the sample manifest.
If leaks occur that cause the box to become visibly soaked, UPS and FedEx may dispose of the box and its contents as a hazard. Additionally, we do not advise shipping out tissue samples over the weekend when they will be in prolonged transit.
Please address all shipments to the following:
VDx Preclinical
215 C Street, Suite 301
Davis, CA 95616
Can I submit prepared slides or digital slides (whole slide images) for evaluation by a VDx pathologist?
Absolutely! Please contact us to discuss and schedule your study.
I only need histology preparation for my study – can VDx help?
Yes! In addition to our pathologist-supported studies, VDx Preclinical provides histology preparation only support to our clients – ranging from processing of pre-trimmed tissues, to full tissue dissection and slide preparation. Please contact us to discuss and schedule your study.
What histology staining do you provide?
VDx offers a wide array of histological staining, from standard Hematoxylin & Eosin (H&E) staining, to routine and complex special stains and immunohistochemistry (IHC). Slide staining for cytology slides, including special stains and immunocytochemistry (ICC) is also available.
VDx Special Stains
If the stain you need for your study is not on our current list, please contact us to discuss further.
- AFB (Ziehl-Nielson) or (Fite’s)
- Alcian Blue
- Amyloid (Congo Red)
- Bielschowsky-PAS
- Calcium (Von Kossa)
- Copper (Rhodanine)
- Elastin
- Elastin Trichrome
- Giemsa (May-Grunswald)
- GMS
- Gomori’s Reticulin
- Gram (Brown & Brenn)
- Grimelius
- Hall’s Bile
- HBFP
- Iron (Prussian Blue)
- LFB (with H&E)
- Luxol Fast Blue (LFB)
- Masson’s Trichrome
- Melanin (Fontana Masson’s)
- Melanin Bleach
- Movat’s Pentachrome
- PAS
- PTAH
- Safranin-O
- Toluidine Blue
- Warthin Starry
VDx IHC / ICC Stains
Please contact us for our current list of available stain protocols. Additionally, if the stain you need for your study is not on our list, we would be happy to discuss staining optimization and protocol development.