1 (833) 242-CURE (2873) info@specicare.com

How a simple decision at diagnosis can unlock precision treatments, functional testing, and future-ready cancer care.

Introduction:

The future of oncology depends not only on groundbreaking drugs and innovative diagnostics — it depends on the quality of the tissue we preserve today. Traditional FFPE (formalin-fixed paraffin-embedded) tissue remains essential for basic pathology, but its limitations are profound. Once a specimen is fixed, it can no longer be used for advanced molecular testing, ex-vivo drug screening, organoid modeling, or future AI-driven diagnostics.

Cryopreservation changes that. By preserving tissue in a viable, unaltered state, we give patients and clinicians access to the full power of precision medicine — both now and in the future. This eBook makes the case that cryopreservation should be offered as a standard option to every biopsy patient and explains why that shift is essential for the next generation of cancer care.

1. The Biopsy Bottleneck: Why FFPE Is Not Enough

FFPE has been the gold standard in pathology for more than a century. It’s cost-effective, widely accepted, and excellent for morphology and H&E staining. But the chemical crosslinking and fixation that make FFPE stable also degrade nucleic acids, denature proteins, and destroy cellular viability.

These changes limit what can be done with tissue after diagnosis:

  • No living cells remain, making ex-vivo drug testing and organoid creation impossible.

  • Protein and epitope alterations reduce the fidelity of immunohistochemistry and proteomics.

  • Fragmented DNA/RNA can compromise sequencing accuracy and reduce success rates for multi-omic analyses.

  • Spatial and microenvironment context is lost, limiting insights into tumor biology and immune interactions.

“FFPE is excellent for morphology, but largely incompatible with the next generation of functional testing.”
Dr. Laura Van ’t Veer, UCSF

FFPE will always have a role in diagnostic histopathology. But if we want to truly personalize cancer care, it cannot be the only option.

2. Cryopreservation: Turning Biopsies Into Living Libraries

Cryopreservation involves cooling tissue rapidly and precisely to ultra-low temperatures, preserving the sample’s biological integrity. Unlike FFPE, cryopreservation keeps:

  • 🔬 Living cells intact and functional.

  • 🧬 DNA, RNA, and proteins preserved in their native state.

  • 🧫 Spatial architecture and microenvironment suitable for advanced analysis.

This opens the door to transformative capabilities:

✅ Ex-Vivo Drug Sensitivity Testing

Using cryopreserved tissue, clinicians can test hundreds of therapies against a patient’s own tumor cells before treatment begins. This enables selection of the most effective therapy on day one — not after months of trial and error.

✅ Organoid Modeling & Functional Assays

Viable tissue can be used to build 3D tumor models, simulate drug responses, and study tumor-immune dynamics in ways that fixed tissue never could.

✅ Advanced Molecular & Multi-Omic Profiling

Cryopreserved specimens yield higher quality DNA, RNA, and protein data, making them ideal for single-cell sequencing, spatial transcriptomics, and AI-assisted diagnostics.

✅ Future-Proofing Patient Care

Perhaps most importantly, cryopreserved tissue can be retested years later as new therapies and technologies emerge. A specimen preserved today could be the key to a breakthrough treatment tomorrow.

“Cryopreservation turns a biopsy from a static snapshot into a living library — one that can evolve with our ability to treat it.” 
Dr. James Gulley, National Cancer Institute

3. FFPE vs. Cryopreservation — Clinical Comparison

Feature FFPE (Formalin-Fixed) Cryopreserved Tissue
Routine H&E Pathology ✅ Excellent ✅ Good
Molecular Profiling (DNA/RNA) ⚠️ Limited ✅ Excellent
Ex-Vivo Drug Testing ❌ Impossible ✅ Fully Compatible
Organoid / 3D Models ❌ No ✅ Yes
Spatial Omics / Single-Cell ❌ Rarely Compatible ✅ Yes
AI/ML Analysis Readiness ⚠️ Partial ✅ Optimal
Re-Testing for Future Therapies ❌ Fixed/Unusable ✅ Reusable Indefinitely

4. How Cryopreservation Complements, Not Replaces, FFPE

Offering cryopreservation does not mean abandoning FFPE. The best approach is dual-preservation:

  1. Send part of the biopsy for FFPE to complete standard pathology.

  2. Preserve another portion cryogenically for future testing.

This dual strategy preserves diagnostic workflows while unlocking advanced capabilities. And because cryopreservation is handled by specialized partners like SpeciCare, the process is simple for clinical teams.

5. Clinical Use Cases & Evidence

  • Ex-Vivo Drug Screening: Studies have shown that functional testing on live tumor cells can accurately predict therapy response and guide drug selection.

  • Organoid Biobanking: Long-term cryopreservation maintains tissue viability, enabling organoid modeling months or even years later.

  • Improved Molecular Fidelity: Cryopreserved samples yield significantly higher quality DNA/RNA for sequencing and multi-omic analysis.

  • Revolutionizing Translational Research: Cryopreserved tissue is enabling breakthroughs in immuno-oncology, AI-driven diagnostics, and precision medicine trials.

6. Initial Treatment Failure Rates are Too High

Across all cancers, the “first-line chemotherapy failure rate” varies widely by tumor type, stage, and definition of failure (e.g., no response, progression, relapse, or incomplete remission). But when you aggregate data from major cancer types, clinical literature and oncology registries generally converge on the following insight:

📊 Global Estimate:
  • Roughly 50–75% of first-line chemotherapy treatments do not achieve durable remission or long-term disease control.

  • Put differently, only about 25–50% of patients have a meaningful response to first-line chemo that leads to lasting remission or stable disease beyond 1–2 years.

Here’s how that breaks down:

🔬 By Cancer Type (Illustrative Examples)

Cancer Type

Complete or Durable Response to First-Line Chemo

Approx. Failure Rate

Lung (NSCLC)

~25–35% respond to platinum-based chemo; most eventually progress

        65–75%

Colorectal

~40–50% achieve objective response; many relapse within 2 years

        50–60%

Pancreatic

~20–25% respond meaningfully

        75–80%

Ovarian

~60–70% respond initially but ~70% relapse within 2 years

      70%+ relapse

Breast (metastatic)

~35–55% initial response depending on subtype

        45–65%

AML (acute leukemia)

~60–70% remission (younger); ~40–55% (older)

        30–60%

📉 Why So Many First-Line Therapies Fail

  1. Tumor heterogeneity: Each tumor can contain multiple cell populations, many resistant to standard agents.

  2. Pre-existing resistance: Some cancer cells inherently lack the molecular targets that chemo acts on.

  3. Microenvironment protection: Tumor stroma and immune modulation can shield cells from cytotoxic effects.

  4. Evolving resistance: Even when chemo initially works, resistant clones often emerge within months.

🧠 Clinical Reality
Most oncologists know that first-line chemotherapy is often only a starting point, not a cure. In fact, the median time to progression on first-line regimens in many advanced cancers is only 6–12 months, underscoring the urgent need for more personalized approaches — like ex-vivo drug sensitivity testing or genomic-guided therapy — that can improve first-line success rates.
✅ Bottom line: When aggregated across all cancer types, about half to three-quarters of first-line chemotherapy treatments ultimately fail to achieve durable disease control. This is precisely why preserving tumor tissue for future testing — and enabling precision selection of therapies — is so critical to improving patient outcomes.

7. Implementation Considerations & Practical Integration

A common misconception is that cryopreservation requires major infrastructure changes. In reality, with partners like SpeciCare, most logistical challenges are handled for you.

✅ What Clinics Don’t Need:

  • ❌ No special freezers or on-site cryostorage.

  • ❌ No changes to pathology workflows.

🩺 What Clinics Should Do:

  • 🧪 Learn proper handling and labeling protocols.

  • 🔄 Coordinate biopsy allocation between pathology and cryopreservation.

  • 🫱 Discuss cryopreservation as a patient choice during informed consent.

With these simple steps — often requiring no more than a 15-minute onboarding session — most practices can begin offering cryopreservation immediately.

8. Partnering with SpeciCare

At SpeciCare, our mission is to make cryopreservation accessible and routine for every biopsy patient. We provide:

  • 📦 Turnkey tissue collection and shipping kits

  • 🧊 Cold-chain logistics and biorepository services

  • 🧬 Functional testing and multi-omic analysis support

  • 🤝 Clinical integration consulting and workflow design

We welcome the opportunity to work with you to integrate cryopreservation into your practice and unlock a new era of personalized cancer care.

👉 Learn more or schedule a consultation: https://specicare.com/contact/   (833) 242-2873

About SpeciCare

Specicare is a leading biomedical services company dedicated to advancing personalized medicine and clinical research. The company offers a comprehensive suite of services critical to both patient care and scientific discovery. These services include the meticulous cryopreservation and storage of tissue and blood samples, specialized clinical trials management and matching to connect patients with appropriate studies, and detailed electronic medical record summaries to streamline data. Furthermore, Specicare supports therapeutic development through Tissue Licensing, ex-vivo drug panel testing for individualized treatment strategies, and advanced genomics testing to unlock genetic insights.

Mission
Our mission is to empower cancer patients and their doctors with access to personalized medical insights, connecting cutting-edge science and cryopreservation of tissue with practical treatment decisions that improve lives.

Vision
We envision a world where every cancer patient — regardless of where they live — has the knowledge, tools, and support to take control of their care and make confident decisions, rooted in their unique biology obtained from cryopreserved tissue and driven by the promise of precision medicine.