FAQs

Frequently asked questions about our solutions

Our wide range of solutions covers the oncology spectrum—from drug discovery to clinical treatment. Browse frequently asked questions about our solutions below. 

 

How can I work with 3D tumor models and what are the deliverables?
Contact us by filling out a form at the bottom of this page. We will be in touch to set up a call to discuss the details of your project. We will then provide a budget and timelines based on the study parameters.

For every project you will receive a report summarizing the key findings of the study. Additional deliverables are usually project specific and can include data tables, images, frozen cell pellets and culture supernatants.

I don’t see the system I need. Can I request a custom model?
Absolutely. We love to work on new models and welcome such requests. All custom models are developed by a dedicated team of scientists with expertise in a specific disease or site of interest. To get started, contact us with your model specifications. We will set-up a call to discuss your requirements and model specifications. If necessary, we will put a non-disclosure agreement (NDA) in place to protect any sensitive information. We will then provide you timelines and a budget for the development of your custom model. As a general guideline, a custom model will take 6-9 months to develop and validate with primary cells. You will work with a team of scientists and will receive regular progress reports for each development milestone.

What is 3D culture?
3D culture is a method of culturing cells that promotes formation of 3-dimensional (3D) cellular structures—spheroids, networks, tubules, etc. 3D culture format is preferable to the standard 2D culture, where cells are grown in a monolayer on the surface of cell culture plastic, because it provides a more physiological milieu.

How does our technology differ from other 3D culture platforms?
Our technology is based on 1:1 reconstruction of human tissues comprising of our proprietary organ-specific extracellular matrix (ECM) formulations and disease-specific medium supplements. Our ECM formulations are assembled from natural components. We do not use synthetic hydrogels or plant material; all our matrices have >90% identity with human ECM.

Our models do not simply force cells to clump into 3D structures, they provide a physiologically-relevant milieu where cell-cell and cell-ECM interactions mirror the native architecture of human tissues.

What is our organ-specific ECM?
Each of our organ-specific extracellular matrices is a mixture of ECM components—collagens, laminins, fibronectin, hyaluronic acid, etc.—formulated to mimic the ECM of each human tissue. Once mixed with cells and placed in a well of a cell culture plate it polymerizes to form a semi-solid environment where cells form 3D structures and establish cell-cell and cell-ECM interactions consistent with the architecture of the native tissue.

What is the difference between our various platforms (i.e. r-Bone vs r-Lung)?
Each of our model systems is designed to mimic the organ and the disease of interest. For example, our r-Bone system for multiple myeloma is composed of the bone marrow-specific ECM and multiple myeloma-specific medium supplements. The ECM provides the scaffold mimicking the endosteum and central marrow and the medium supplements provide the multiple myeloma cytokine environment. The same general principle applies to all our model systems.

Are the cells mixed with the ECM or do they grow on top of it?
Both are possible. However, mixing cells with the ECM establishes a more physiologically relevant system. Prior to adding cells, the ECM is a viscous liquid, which polymerizes at room temperature allowing the cells to be suspended within the ECM layer. Growth medium with disease-specific supplements is then overlaid on top of the cell/ECM layer. Over time, cells proliferate and migrate throughout the ECM layer forming 3D structures (i.e. spheroids, tubes, networks).

ls the ECM integrity maintained in presence of proteases produced by the tumor cells?
ECM stays polymerized throughout the course of the culture. However, its stiffness is model-dependent and can become looser when culturing highly aggressive migratory cells.

What is the thickness of your cultures?
The average thickness of the ECM in our models is 800?m-1mm and can be modulated depending on the study goals.

Do therapeutic agents penetrate our ECM after it has polymerized?

Yes. We have tested small molecules, antibodies, antibody-drug conjugates (ADC), and cellular therapies, such as CAR-Ts; in all cases we observe targeted elimination of tumor cells at all depths within the culture.

How long can you maintain primary cells in culture?
Our systems are validated to maintain viability for at least 21 days. However, most models can support primary cells for >30 days. For r-Bone cell cultures we can maintain primary cells in our models for up to 35 days, the maximum duration tested.

What type of therapeutic agents can be tested in reconstructed organ?
Any type of therapeutic agent can be used in reconstructed organ: small molecules, antibodies, antibody-drug conjugates, biologic agents, cell therapeutics (i.e. CAR-T cells).

Why do you wait 3-5 days prior to adding treatment to your culture systems?
We do not add therapeutic compounds to our model systems immediately post setup to avoid artificially skewing the results due to cellular stress and non-physiological cell organization. Culturing cells for 3-5 days gives them a chance to acclimate to the system and to form physiologically relevant cell-cell and cell-ECM interactions that drive the environmentally-mediated drug resistance (EMDR). Setting-up proper tissue architecture is crucial for the accurate prediction of drug response.

What should be the sample viability to obtain successful growth in the culture?
For successful cultures, the cells must retain >70% viability after thaw.

What is r-Bone?
Reconstructed Bone (r-Bone) is a 3D cell culture model system designed to reconstruct the bone marrow tissue for long-term culture of primary bone marrow cells. The first component of the r-Bone model is the ECM that provides the semi-solid scaffold reconstructing two distinct niches within the human bone: (1) the the endosteum, an interphase between the solid bone and the bone marrow, and (2) the central marrow. The second component is the medium supplement is formulated to mimic the disease-specific circulatory environment.

What indications have you tested in r-Bone?
The r-Bone system has been tested with primary bone marrow cells from patients with AML, multiple myeloma, MGUS, plasma cell leukemia, amyloidosis, as well as non-malignant bone marrow from healthy donors.

Can you culture both fresh and cryopreserved bone marrow samples in r-Bone?
Yes, both fresh and viably cryopreserved bone marrow samples can be cultured in r-Bone. Fresh samples are first run through a Ficoll gradient to isolate bone marrow mononuclear cells (BMMCs), which are then mixed with the r-Bone ECM and plated. Cryopreserved BMMCs are directly mixed with the r-Bone ECM without additional processing. For successful cultures, the cells must retain >70% viability after thaw.

Does r-Bone support both hematopoietic and stromal compartments of the bone marrow?
Yes. Lymphoid, myeloid, and stromal populations present in the patient sample prior to culture are present after 21 days of culturing in r-Bone.

Do malignant plasma cells from the BMMCs of multiple myeloma patients expand in r-Bone?
Yes. The primary malignant multiple myeloma plasma cells proliferate in r-Bone. The extent of the expansion is patient dependent, but we routinely observe 2-10-fold expansion of the malignant clone.

Can I follow proliferating cells in r-Bone?
Yes, BMMCs can be labeled with CFSE prior to plating in the r-Bone ECM. Proliferation can then be observed by microscopy, flow cytometry, or fluorescence measurement on a plate reader.

Do you enrich for multiple myeloma plasma cells before culturing in r-Bone?
No. To retain the heterogeneity of the ex vivo samples, we culture the mononuclear cells obtained from the bone marrow aspirates through Ficoll gradient.

Have you tested standard of care drugs against multiple myeloma in r-Bone?
Yes. Some of the drugs that have been tested in the r-Bone include: bortezomib, carfilzomib, lenalidomide, pomalidomide, daratumumab, dexamethasone and various combinations, such as RVD and CPD.

What readout is compatible with our technology?
Our technology is compatible with any standard readout techniques, including but not limited to, flow cytometry, microscopy, plate reader-based cell assays (CellTiter Glo, MTS, etc.), nucleic acid analysis (RNAseq, qPCR, arrays, etc.), proteomics, and in vivo studies.

Cells can be isolated from the organ-specific ECM using our proprietary non-enzymatic isolation solution that is compatible with flow cytometry and any other readout strategies that require intact surface receptors. Moreover, cells remain viable after isolation and can be subsequently used in both in vitro and in vivo studies.

What is the detection limit in our models?
The dynamic range of CellTiter Glo assay in our models is 10-80,000 cells per well in a 96-well plate.

Is it possible to image through the culture?
Yes, in-matrix imaging is possible. Our 3D tumor models systems have been tested with brightfield, fluorescence, confocal and high content imaging methods.

What is the cell viability and yield post isolation?
We routinely obtain cells with >70% viability post isolation from untreated cultures. The yield is model dependent since different numbers of cells are plated per well depending on the tissue being reconstructed. For example, in rBone the yield from a single well of a 96-well plate is approximately 100,000 cells, but from r-Lung, it is ~20,000 as the plating densities and proliferation properties of the cells differ significantly between these models.

Do you get enough material for gene expression analysis?
Yes. The number of wells required to obtain enough material will depend on the model type and cell plating density.

What is tumor drug-response testing

Drug-response profiling is a treatment selection marker. It determines how an individual cancer patient’s tumor is likely to respond to the various types of chemotherapy by testing the treatment options on that patient’s live cancer cells and measuring cell response. This provides valuable insights that help guide physicians’ treatment decisions, giving you an edge against cancer.

What is genomic testing?
Genomic testing is a group of clinically relevant cancer-related biomarker tests that look at your genetics to predict your cancer’s response to various types of chemotherapy and/or the course your disease is likely to take. The biomarkers included in genomic testing are well-validated and supported by current research and key opinion leaders.

Why have a tumor tested with us?
Your physician is using every advantage available to improve the odds in your fight against cancer. Combining drug-response profiling and genomic profiling of your tumor generates a more comprehensive picture to provide information to help your oncologist individualize your therapy. These tests are designed to reduce your risk of receiving therapies that are ineffective or to identify alternatives when the typical treatments recommended for your type of cancer cannot be tolerated.

How does a tumor get tested?

Tumor tissue is obtained during surgery and your oncologist will send that tissue to our CLIA-certified laboratory using our special collection kit. Two samples of your tumor tissue are obtained, fixed and live. The fixed tumor tissue is used for a panel of genomic biomarker tests. The live tumor tissue is grown in the lab and used to test the drug response of the tumor to a panel of standard-of-care (SOC) drugs. When testing is complete a report is provided back to your clinician with recommended SOC therapies based on the drug response and genomic profiles.

What is the value of having a tumor tested?

The data generated from testing the unique mutations of your tumor and from the drug response profiling, which essentially performs chemotherapy on your tumor outside of the body, provides information to your oncologist to improve the odds in your fight against cancer. In addition, and with your consent, de-identified data generated by testing your tumor is added to our cancer knowledgebase of existing tumor data. Deeper analysis of this data will improve the recommendations we give to clinicians to help patients like you, as well as provide insights to guide research into new cancer therapies.

How much will it cost?
We are committed to providing access to functional precision medicine to as many people as possible. Our panel of biomarker/genomic tests are covered by most insurers/Medicare. We have continued to offer tumor drug-response tests amidst reimbursement uncertainty from both commercial insurers and Medicare. Due to continued clinical demand and interest across the community, we remain committed to meeting the needs of patients. To keep this testing available to patients and their treating physicians, we offer our tumor drug-response profiling at a drastically reduced rate such that no patient will pay more than $615. We also provide a Compassionate Care Program for those patients who need further help with payment. Contact us for more information.

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Shareholder Q&A

We sat down for a Q&A with investors in a conversation moderated by Shareholder Nathan Reese. Watch our recording of the webcast here. 

Learn more

David S. Smith

DIRECTOR

David S. Smith, JD, is a life sciences and intellectual property attorney, veteran biotech industry executive and leading authority on the legal issues surrounding the therapeutic use of human tissue and cells. He has extensive transactional experience, venture financings and regulatory matters for life sciences companies and investors.

Mr. Smith frequently speaks on matters related to the commercial development of tissue, cell and stem cell technologies, and has authored extensively on topics like human tissue therapies and tissue engineering research. He currently serves on the Board of Directors with Foundation for Cell and Gene Medicine; is a current fellow and past member of the executive committee of Tissue Engineering and Regenerative Medicine International Society; was a member of the Board of Directors of the Pennsylvania Biotechnology Association; and was a past officer of the Pittsburgh Tissue Engineering Initiative.

“ Having worked in the healthcare industry for over 30 years, helping the companies who deliver patient care utilize the best technology, improve their processes and receive all the revenue they can within all compliance standards;
I was excited to join Predictive Oncology’s Board of Directors in helping to guide this exciting company with all of their cutting edge capabilities for improving
the health care of patients
with cancer.”

Pamela Bush, Ph.D.

SVP, Strategic Sales and Business Development,

PREDICTIVE ONCOLOGY
At Predictive Oncology

Pamela Bush comes with more than twenty years of experience in venture creation, finance, and business development in the life sciences industry. At POAI, she leads the sales efforts and business development activities across the portfolio.

Before Predictive Oncology

Prior to joining POAI Pamela worked at Eli Lilly & Company in various roles including Corporate Business Development, Finance and Patient Services. In addition to her Lilly work experience, Pamela has worked in economic development, academia, and business consulting supporting the creation and growth of 80+ life sciences start-ups.

“ POAI has developed solutions to help biopharma partners increase the probability of success of their oncology pipeline.”

Education
Carnegie Mellon University

Ph.D., Molecular Biology
MBA, Tepper School of Business

Lawrence J. DeLucas, Ph.D

SVP, OPERATIONS,
Predictive Oncology
President, Soluble Biotech
At Predictive Oncology

Dr. DeLucas is the Vice president of Operations for Predictive Oncology and President and co-founder of Soluble Biotech, Inc. DeLucas is currently working to complete development of GMP facilities at Soluble Biotech and at TumorGenesis. In addition, he oversees Soluble Biotech’s solubility and stability contracts for numerous pharmaceutical/biotech companies.

Before Predictive Oncology

From 1981-2016 Dr. DeLucas was a faculty member at the University of Alabama at Birmingham (UAB) where he served as a Professor in the School of Optometry, Senior Scientist and Director of the Comprehensive Cancer Center X-ray Shared Facility, and Director of the Center for Structural Biology. Dr. DeLucas received five degrees from UAB culminating in a Doctor of Optometry degree and a Ph.D. degree in Biochemistry. He also received honorary Doctor of Science degrees from The Ohio State University, Ferris State University, the State University of New York (SUNY), and the Illinois College of Optometry. He has published 164 peer-reviewed research articles in various scientific journals, co-authored and edited several books on protein crystal growth and membrane proteins and is a co-inventor on 43 patents involving protein crystal growth, novel biotechnologies and structure-based drug design. DeLucas was a payload specialist NASA astronaut and member of the 7-person crew of Space Shuttle Columbia for Mission “STS-50”, called the United States Microgravity Laboratory-1 (USML-1) Spacelab mission. Columbia launched on June 25, 1992, returning on July 9.  In 1994 and 1995, Dr. DeLucas served as the Chief Scientist for the International Space Station at NASA Headquarters in Washington, D.C. In 1999, Dr. DeLucas was recognized as one of the scientists who could shape the 21st century in an article published by “The Sunday Times” of London titled “The Brains Behind the 21st Century.”  In 2004, he was recognized as a Top Ten Finalist for the Entrepreneur of the Year award from the Birmingham Business Journal. 

“ Soluble Biotech is continually demonstrating to pharmaceutical and biotech companies the significant value of its novel HSC technology for optimizing protein therapeutic formulations to treat a variety of chronic and infectious diseases. ”

Education
  • Five degrees from Univ. of Alabama at Birmingham (UAB): B.S. Chemistry, M.S. Chemistry, B.S. Physiological Optics, O.D. Optometry, Ph.D Biochemistry
  •  
  • Published 164 peer-reviewed research articles in various scientific journals
  •  
  • 1993-2016: Director of the UAB Comprehensive Cancer Center X-ray Shared Facility, and Director of the Center for Structural Biology
  •  
  • NASA Astronaut, flew on Columbia Space Shuttle
  •  
  • 1994-1995: Appointed Chief Scientist for the International Space Station at NASA HQ

Arlette Uihlein, MD, FCAP, FASCP

Dr. Arlette Uihlein is Senior Vice President of Regulatory Affairs and Quality for Predictive Oncology and Site Leader of Helomics, serving as the Vice President of Operations, Pathology Services and Medical Director of Helomics® Clinical and Research Labs since 2011. Dr. Uihlein is Board Certified in Anatomic and Clinical Pathology, Cytopathology and Family Medicine. Dr. Uihlein completed her Pathology Residency at Allegheny General Hospital, where she served as Chief Resident in Pathology and completed Fellowships in Cytopathology and Surgical Pathology. During that time, she conducted extensive clinical research involving molecular pathology diagnostic and predictive markers, imaging of solid tumors, and novel applications of cellular tumor markers. While serving as Medical Director at Helomics, a CLIA and New York State certified lab, Dr. Uihlein has published research in molecular assay development, lab automation, and tissue and cell processing. She is a Designated Civil Surgeon for the U.S. Dept. of Justice and a certified Medical Review Officer for the Department of Transportation. She is a Fellow of the College of American Pathologists and the American Society of Clinical Pathology, NYSDOH Certificate Qualified, and a member of ASCO.

“ At Helomics we’re delivering better-informed decision making saving pharma time and money, while providing cancer patients with appropriate therapies.”

 

 

Education

Medical College of Ohio
Doctor of Medicine

Baldwin-Wallace University
BS, Biology

Richard Gabriel, BS, MBA

SVP, RESEARCH & DEVELOPMENT
Predictive Oncology
Site Leader, TumorGenesis
At Predictive Oncology
My role at Predictive Oncology is to bring the business sense to managing Research and Development programs at all our companies. To seek new ways and opportunities to commercialize exciting new technologies that we have built, licensed, acquired, or are developing through our own research and development. The success of any company is to get the research off the bench and to the customers. That is what I do at POAI and help the other companies as well.
Before Predictive Oncology
Prior to starting his first company in 1984 and registering with the FDA a pilot plant facility to make pharmaceutical actives, Mr. Gabriel managed a $50 million product line for W.R. Grace, developed new marketing and sales strategies for Ventron a Division of Morton Thiokol, research work at Ashland Chemical for pressure sensitive adhesives and plant scale-up. Since then, he ran a genetics company, built three GMP/Research facilities, and helped 5 drugs reach their markets in AIDS and cancer. Real expertise in cGMP process scale-up and compliance. Completely understand the needs of an API manufacturing facility and build processes that are scalable, environmentally acceptable, and safe. 3 FDA inspections with no 483’s, ISO certification, DEA registration, DoD compliance, NCI contractor and inventor. Has also broad-based experience in start-up companies and how to make them operational and profitable. 7 years of Team set-up, R&D management, and implementation for 165-person (85 PhD’s and Engineers) company (Pharm-Eco) and lecturer on cGMP and Teams within the Pharmaceutical Industry.

“ Patients are always first, is our driving force. Oncology is a tough space, and we are determined to bring the best validated science to help cancer patients and as our CEO says, ‘Eliminate Cancer.’ That takes teamwork and a lot of smart hard-working people, our team members at POAI are up to the challenge. ”

 

 

Education
Suffolk University
Executive MBA Program

Ohio Dominican College
BS, Chemistry

Ohio State University
Microbiology and Virology

University of Cincinnati
Associates Degree, Liberal Arts

Bob Myers, BBA, MBA

CHIEF FINANCIAL OFFICER
Predictive Oncology
Site Leader, Skyline Medical
At Predictive Oncology

Executive Officer, Compliance Officer, Corporate Secretary, and member of the Senior Leadership Team. Responsible for Finance, Administration, Human Resources, Investor Relations, and IT. Skyline Medical Site Leader.

Before Predictive Oncology

Numerous years as CEO/Controller consultant including medical devices companies. Executive positions with CES Computer Solutions, Computer Accomplishments, Hi-Tech Stationary & Printing, Capital Distributors Corp, International Creative Management American Express, Showtime Entertainment and public accounting with Laventhol & Horwath, CPA’s.

“ It’s a privilege to work with a highly talented team to pursue oncology advances, while protecting and increasing shareholder value. ”

Education

Adelphi University
MBA, Finance

Hofstra University
BBA, Public Accounting 

Raymond Vennare

CHIEF EXECUTIVE OFFICER
& CHAIRMAN OF THE BOARD
Predictive Oncology
At Predictive Oncology

Raymond F. Vennare became Predictive Oncology’s CEO and Chairman of the Board on November 1, 2022. He has served on the Board of Directors since September of 2021.

Mr. Vennare brings more than thirty years of experience as an accomplished senior executive, board director and biotechnology entrepreneur. As a seasoned professional who has founded, built and managed multiple companies on behalf of institutional investors, private foundations and research institutions, Mr. Vennare has a long history of leading companies that range from bioinformatics, diagnostics and therapeutic drug delivery to FDA-cleared medical devices. Throughout his career, Mr. Vennare has played a key role in the capitalization, development and commercialization of innovative and novel technologies.

Since 2015, Mr. Vennare has served as CEO and Chairman of Cvergenx, Inc., a genomic informatics company developing decision-support tools for radiation oncology, and is currently an Investment Partner in Inventeur, LLC, a holding company of medical technologies in anesthesiology. Mr. Vennare’s previous experience includes co-founding ThermalTherapeutic Systems, Inc., where he served as President and Chief Executive Officer, President and Chief Executive Officer of ImmunoSite, Inc., Senior Vice President and Chief Information Officer of TissueInformatics, Inc., and President of VS/Interactive.

 

Mr. Vennare earned his undergraduate degree from the University of Pittsburgh (BA) and holds graduate degrees from Duquesne University (MS) and Case Western Reserve University (MA).

What we do for our customers today will directly impact the lives of those patients who may benefit by these discoveries in the future.”