Straightforward ordering process to access OncoForma's organoid testing for your patients
Patient Eligibility
OncoForma testing is appropriate for patients with solid tumors who meet the following criteria:
Eligible Patients
- Diagnosis: Confirmed solid tumor malignancy (any stage)
- Clinical Scenario:
- Treatment-naïve patients planning first-line therapy
- Patients with disease progression on current therapy
- Patients with limited standard treatment options
- Patients considering experimental or off-label therapies
- Sample Availability: Fresh tissue or malignant fluid accessible via biopsy, surgery, or drainage procedure
- Timeline: Sufficient time window (3-4 weeks) to await results before urgent treatment decision required
- Performance Status: Expected survival ≥3 months to benefit from results
How to Order
OncoForma offers three convenient ordering methods:
Option 1: Online Portal (Recommended)
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Create Account: Register at portal.oncoforma.com using your medical license number
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Complete Test Requisition: Enter patient demographics, diagnosis, prior treatments, and clinical question
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Obtain Patient Consent: Download and complete informed consent form with patient signature
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Coordinate Sample Collection: Schedule biopsy or surgical procedure; coordinate with pathology
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Ship Sample: Use provided shipping kit with prepaid overnight label
Option 2: Phone/Fax Ordering
Phone: 1-800-ONCOFORMA (1-800-662-6367)
Fax: Download requisition form and fax to (306) 555-0199
Hours: Monday-Friday, 8 AM - 6 PM Central Time
Option 3: Clinical Liaison Support
For complex cases or institutions interested in establishing an ongoing relationship, request a dedicated clinical liaison who will:
- Assist with patient selection and eligibility determination
- Coordinate directly with pathology and surgery for sample collection
- Manage shipping logistics and track sample in real-time
- Provide results consultation and treatment interpretation
Contact us at clinical@oncoforma.com to request a liaison.
Sample Requirements
Acceptable Sample Types
| Sample Type |
Minimum Requirement |
Preferred Amount |
Notes |
| Core Needle Biopsy |
2-3 cores (18-16 gauge) |
4-6 cores |
Most common sample type; ensure adequate tumor cellularity |
| Surgical Resection |
3-5mm³ fresh tumor |
5-10mm³ |
Ideal for organoid culture; coordinate with pathology to ensure diagnostic needs met first |
| Malignant Pleural Effusion |
50-100 mL |
100-200 mL |
Cytology must confirm malignant cells |
| Malignant Ascites |
50-100 mL |
100-200 mL |
Cytology must confirm malignant cells |
| Fine Needle Aspirate (FNA) |
Contact lab first |
N/A |
Generally insufficient; discuss with OncoForma team for specific scenarios |
Sample Collection Guidelines
Critical Requirements for Sample Viability:
- Fresh, Never Frozen: Samples must be fresh tissue collected within 24 hours of shipping. NEVER freeze samples intended for organoid culture.
- Sterile Collection: Use sterile technique during biopsy/surgery to minimize contamination
- Appropriate Medium:
- Tissue: Place in sterile saline, RPMI, or provided transport medium (NOT formalin)
- Fluids: Collect in sterile heparinized tube or container
- Temperature: Store and ship at room temperature (15-25°C). Do not refrigerate or freeze.
- Timing: Ship same day as collection via overnight courier to arrive within 24 hours
Pathology Coordination
To ensure adequate tissue for both diagnostic pathology and organoid testing:
- Inform Pathology: Notify pathology team in advance that additional fresh tissue is needed for OncoForma testing
- Diagnostic Priority: Pathologist should allocate tissue for diagnosis FIRST, then provide remaining viable tumor for research
- Tumor Assessment: Request pathologist to visually identify tumor-rich areas and select samples with ≥30% tumor cellularity
- Rapid Processing: Coordinate to minimize time between sample collection and placement in transport medium
Shipping Instructions
Shipping Kit Contents
OncoForma provides a complimentary shipping kit containing:
- Sterile specimen container with transport medium
- Absorbent packaging materials
- Pre-labeled insulated shipping box
- Prepaid overnight shipping label (FedEx Priority Overnight)
- Step-by-step shipping instructions
Shipping Protocol
- Place fresh tumor specimen in provided sterile container with transport medium
- Seal container and place in absorbent pouch
- Place pouch in insulated shipping box (no ice packs required - room temperature shipping)
- Affix prepaid overnight label to box
- Call FedEx for pickup or drop at FedEx location for same-day shipping
- Email tracking number to samples@oncoforma.com
Shipping Address:
OncoForma Biotechnologies
ATTN: Sample Receiving
123 Innovation Drive, Suite 200
Saskatoon, SK S7N 2X8
Canada
Hours: Samples received Monday-Friday, 8 AM - 5 PM Central Time. Arrange delivery during business hours to ensure immediate processing.
Turnaround Time
| Milestone |
Standard Turnaround |
Expedited Turnaround* |
| Sample Receipt to Culture Initiation |
24-48 hours |
24 hours |
| Organoid Establishment & QC |
10-14 days |
7-10 days |
| Drug Screening & Analysis |
7-10 days |
5-7 days |
| Total: Sample to Report |
21-25 days |
14-18 days |
*Expedited processing available for urgent clinical scenarios upon request. Additional fees may apply.
Billing & Insurance
Current Billing Status
OncoForma testing is currently available as a laboratory-developed test (LDT) and is in the process of seeking insurance coverage. The following billing options are available:
Option 1: Institutional Billing
For hospitals and cancer centers with research budgets or precision medicine programs:
- Test invoiced directly to institution
- Typical cost: $3,500-$4,500 per test (contact for institutional pricing)
- Volume discounts available for ongoing partnerships
Option 2: Patient Self-Pay
For patients paying out-of-pocket:
- Patient responsibility: $2,995 (self-pay discounted rate)
- Payment plans available through CareCredit and other financing partners
- Financial assistance program available for qualified patients (contact billing@oncoforma.com)
Option 3: Research Studies
OncoForma is actively enrolling patients in clinical validation studies where testing is provided at no cost. Contact research@oncoforma.com to inquire about active studies and eligibility.
Insurance Coverage (In Progress)
OncoForma is actively working with payers to establish coverage policies. Current status:
- Medicare: Coverage determination in progress; anticipate MolDX policy review in 2025
- Private Insurance: Case-by-case prior authorization support available
- Single Case Agreements: Our reimbursement team can work with individual insurers for coverage on a case-by-case basis
Results Delivery & Consultation
Report Contents
OncoForma delivers a comprehensive report including:
- Patient demographics and sample information
- Organoid quality control metrics and culture success confirmation
- Drug sensitivity results for 25-50 tested therapies, categorized as Sensitive, Moderate, or Resistant
- Dose-response curves and IC50 values for each tested drug
- Combination therapy synergy analysis
- Clinical interpretation and treatment recommendations from oncology-trained medical team
- References to relevant clinical guidelines and published studies
Report Delivery Methods
- Secure Online Portal: Access report immediately upon release via HIPAA-compliant portal
- Electronic Fax: Report automatically faxed to number provided at time of order
- EHR Integration: Direct integration available for select EHR systems (Epic, Cerner)
Results Consultation
Every OncoForma report includes complimentary consultation with our medical team:
- Standard Consultation: 15-20 minute phone consultation to discuss results and treatment implications
- Tumor Board Presentation: OncoForma team available to present case at institutional tumor boards (virtual or in-person)
- Ongoing Support: Continued access to medical team as treatment evolves and questions arise
Frequently Asked Questions
Can I order a test before the sample is collected?
Yes! We recommend ordering in advance so the shipping kit arrives before your patient's procedure. This ensures no delays in sample shipping.
What if the organoids fail to grow?
While our success rate is 75-85%, some samples do not yield viable organoids. In these cases:
- We will notify you within 7-10 days if culture fails
- No charge is incurred for failed cultures
- We can attempt culture from a second sample if available
- Refund or credit issued if payment was already made
Can I send archived/frozen tissue?
No. Organoid culture requires fresh, viable tumor cells. Frozen or formalin-fixed tissue cannot be used. However, we can sometimes culture organoids from fresh tissue obtained at the time of surgical resection even if primary diagnosis was made from archived tissue.
How do I handle time-sensitive treatment decisions?
For patients requiring immediate treatment initiation, we recommend:
- Starting first-line standard-of-care therapy while awaiting organoid results
- Using results to guide second-line treatment selection if progression occurs
- Requesting expedited processing (14-18 days) when clinically appropriate
Can results change over time or with treatment?
Yes. Tumor biology can evolve with treatment, and acquired resistance mechanisms may develop. For patients on prolonged therapy or those with disease progression, repeat organoid testing from a new biopsy may provide updated drug sensitivity information.
Ready to Order?
Get started with OncoForma testing for your patient today.
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