Recent Biospecimen Projects
Capital Biosciences has supported a wide range of custom biospecimen collections. Representative recent project types are summarized below. More project summaries will be added here. Client names are not shown.
Colorectal cancer plasma
We collect treatment-naive colorectal cancer plasma for liquid-biopsy and screening work. Donors are adults with clinically and morphologically confirmed CRC across common histologic subtypes and grades. Typical inclusion is stage I–III, non-metastatic disease, with blood drawn before surgery or other cancer-directed therapy; a stage I–focused variant further restricts age and excludes IBD, FAP, Lynch syndrome, serrated polyposis, and a strong first-degree family history. Whole blood is drawn in Streck Cell-Free DNA BCT or K2-EDTA tubes, double-spun to plasma, aliquoted, and stored at −80 °C for dry-ice shipment, with recovered plasma in the high-single-digit to low-double-digit milliliter range. Annotations include TNM, pathology conclusion, draw and processing times, and negative HIV, HCV, HBsAg, and syphilis screens; pregnancy, breastfeeding, and those infections exclude.
Multi-indication oncology plasma
The same Streck double-spun plasma workflow is used for a panel of solid tumors when a study needs comparable liquid-biopsy material across indications. Confirmed, treatment-naive cases of bladder, breast, kidney, gastric, liver, lung, melanoma, ovarian, pancreatic, and prostate cancer are collected under IRB-approved consent. Blood is drawn in Streck BCT tubes, processed to plasma, frozen at −80 °C, and shipped on dry ice. Clinical packages include demographics, diagnosis date, TNM and grade, pathology conclusion, treatment status, and infectious-disease screens (HIV, HCV, HBsAg, syphilis). Pregnancy, breastfeeding, and a positive infectious-disease history are excluded.
Colorectal cancer serum
Treatment-naive CRC serum is collected after colonoscopy and before surgery or systemic therapy, with matched healthy-control serum prepared on the same SST workflow. Blood is drawn in serum-separator tubes, clotted at room temperature, centrifuged, aliquoted, and stored at −80 °C. Typical recovered volume is a few milliliters per donor. Annotations cover demographics, histology, TNM, and treatment-naive status. Pregnancy, breastfeeding, and HBV, HCV, or HIV in the clinical history are excluded.
Colorectal cancer stool collection
Prospective stool collections support CRC screening assay development across colonoscopy-confirmed cohorts: normal colonoscopy, hyperplastic polyps, significant polyps, advanced adenoma, and CRC. Adults in mid-to-late adulthood donate 10–20 g of stool, split into sterilized bags and a DNA/RNA-stabilized fecal tube, frozen within an hour of collection and transferred to −80 °C. Collection is timed before colonoscopy or, for some advanced-lesion cohorts, a short interval after. Exclusions include IBD, celiac disease, colitis, recent digestive instrumentation or fecal occult-blood testing, hereditary CRC syndromes, other recent cancers, and infectious-disease history.
Breast cancer plasma
Treatment-naive invasive ductal carcinoma plasma is collected at diagnosis, before anesthesia, surgery, or neoadjuvant therapy, with biopsy-confirmed benign breast findings and age- and BMI-matched non-cancer controls collected on the same protocol. Donors are typically fasted; extremes of BMI and any prior cancer treatment or cancer history are excluded. Whole blood is drawn in K-EDTA (no heparin), processed to plasma within a few hours on ice, aliquoted in equal volumes, and stored at −80 °C. Studies often request lipid and chemistry labs (cholesterol fractions, ALT/AST, creatinine, urea) plus collection-site coding. Pregnancy, breastfeeding, and HBV, HCV, or HIV exclude.
ER-positive and ER-negative breast tissue
Flash-frozen and FFPE breast carcinoma with documented ER-positive or ER-negative status is sourced from surgical resections for receptor-stratified IHC and molecular work. Adults with confirmed invasive carcinoma are included across common grades; treatment-naive material is preferred. Tissue is snap-frozen or fixed in 10% NBF (6–72 h) and paraffin-embedded. Standard data include receptor status when available, TNM, and demographics. Infectious-disease history and pregnancy exclude.
Hormone receptor–positive breast cancer after CDK4/6 inhibitor therapy
FFPE from HR-positive breast cancer collected after CDK4/6 inhibitor treatment is used for post-treatment biomarker work. Biopsies and resections are both acceptable; HR confirmation on the post-treatment block is preferred when available. Blocks are 10% NBF–fixed and stored refrigerated for ambient shipment. Pregnancy, breastfeeding, and HBV, HCV, or HIV in the history are excluded.
HPV-negative head and neck squamous cell carcinoma tissue and plasma
Matched snap-frozen HNSCC tumor and liquid biopsy are collected from HPV-negative (p16- or HPV-negative by local pathology) adults undergoing curative surgery. Current and former smokers are prioritized; later-stage and treatment-naive cases are preferred, with treated cases flagged by line of therapy. Tumor is snap-frozen in LN2 vapor within about an hour of dissection (target cube on the order of 5 mm; FFPE is not accepted). Whole blood is drawn in K-EDTA before surgery, double-spun to plasma within a few hours, and banked with buffy coat; plasma is aliquoted and held at −80 °C. Clinical packages include primary site, TNM, HPV result, tobacco and alcohol history, and treatment history including radiotherapy or immunotherapy.
Pembrolizumab-treated head and neck cancer PBMC, serum, and FFPE
Serial blood collections from HNSCC patients on pembrolizumab, alone or with chemotherapy, support on-treatment immune-monitoring. Whole blood (roughly 10–30 mL per draw) is taken at baseline, mid-cycle, and later pre-infusion visits through the early cycles, then split into viable Ficoll PBMCs (processed within about 12 hours) and SST serum. Optional matched post-treatment FFPE biopsy is 10% NBF–fixed. Frozen fractions ship on dry ice; FFPE ships ambient. Cycle number, TNM, and response data are captured when available. Pregnancy, breastfeeding, and HBV, HCV, or HIV exclude.
Head and neck cancer FFPE, including pre- and post-pembrolizumab pairs
FFPE HNSCC for IHC includes both archive blocks and matched pairs: a treatment-naive primary biopsy plus a post-pembrolizumab biopsy after documented progression, with pembrolizumab given alone or with chemotherapy. Tumor content below about 10% is excluded. Blocks are 10% NBF–fixed (6–72 h), stored at 4 °C, and shipped ambient. Outcome fields (best response, duration of response, PFS, OS) and subsequent therapy are requested when available.
Uterine serous carcinoma FFPE core needle biopsies
FFPE core needle biopsies of uterine or endometrial serous carcinoma are selected for IHC and companion-diagnostic work. Origin is restricted to uterus or endometrium; neuroendocrine carcinoma, endometrial sarcoma, and bone or bone-marrow tissue are excluded. Minimum tumor content is in the mid-30% range with necrosis kept at or below about 25%. Donors are adults; samples are not post-mortem. Blocks are 10% NBF–fixed, HIV/HBV/HCV-screened negative, fully consented for research, and shipped ambient with standard pathology annotations.
Ovarian and uterine carcinoma FFPE after PD-(L)1 therapy
Matched FFPE pairs from ovarian or uterine carcinoma capture a treatment-naive primary biopsy and a post-PD-(L)1 biopsy after documented progression on PD-(L)1 monotherapy or PD-(L)1 plus chemotherapy. Adults with confirmed carcinoma at various stages are included; tumor content below about 10% is excluded. Tissue is 10% NBF–fixed (6–72 h), stored at 4 °C, and shipped ambient. Clinical outcome on the checkpoint inhibitor and on any subsequent line (response, duration, PFS, OS) is requested when available.
Platinum-treated ovarian cancer sequential FFPE
Sequential FFPE from platinum-resistant and platinum-sensitive ovarian cancer follows patients from a pre-platinum block through post-platinum relapse and, when applicable, a later block after doxorubicin, bevacizumab, or gemcitabine. Relapse timing relative to the last platinum dose distinguishes the two cohorts. Tissue comes from debulking surgery or diagnostic biopsy (wedge, excisional, core, or FNA), is fixed in 10% NBF, stored at 4 °C, and shipped ambient. Pregnancy, breastfeeding, and HBV, HCV, or HIV exclude.
Diffuse large B-cell lymphoma FFPE and matched blood
DLBCL collections pair an FFPE block (minimum tumor content around 20%) with whole-blood derivatives: EDTA plasma (high-single-digit milliliter target), buffy coat (at least about 0.5 mL), and viable PBMC. Subjects are pre-treatment, with no restriction on subtype, stage, or demographics beyond adult consent. FFPE is 10% NBF–fixed; plasma, buffy, and PBMC are frozen at −80 °C and shipped on dry ice. Infectious-disease screens and standard lymphoma pathology annotations accompany the set.
Non-small cell lung cancer FFPE
NSCLC FFPE for IHC and molecular profiling is sourced as surgical resections, core or other diagnostic biopsies, and, when requested, matched normal-adjacent tissue. Adenocarcinoma and squamous histologies are both available. Typical quality gates are tumor content of at least about 20–30% and necrosis at or below about 20–25%. Blocks are 10% NBF–fixed (6–72 h) and shipped ambient with TNM, grade, and treatment status. Treatment-naive, TKI-treated, and outcome-annotated series are all in scope.
NSCLC after immune-checkpoint inhibitor therapy
Matched NSCLC FFPE pairs combine a treatment-naive primary biopsy with a post-PD-(L)1 biopsy after documented progression on PD-(L)1 alone or with chemotherapy. Inclusion is advanced (stage IIIA/IIIB) or metastatic (stage IV) squamous or adenocarcinoma. Tumor content is typically at least about 50% with necrosis at or below about 40%. Fixation is 10% NBF; blocks store at 4 °C and ship ambient. Outcome and subsequent-therapy data are requested when available.
EGFR-positive NSCLC after TKI therapy
Primary NSCLC adenocarcinoma FFPE collected after documented EGFR-directed TKI therapy, including cases that also received chemotherapy. Blocks may be trephine biopsies or surgical resections, generally less than ten years old, with tumor content of at least about 30% and necrosis at or below about 20%. EGFR status and TKI exposure are confirmed in the clinical notes. Fixation is 10% NBF; shipment is ambient.
NSCLC plasma, serum, and cytology
NSCLC liquid and cytology collections include EDTA or Streck plasma, SST serum from treatment-naive stage I–II donors with heavy-smoker nodule-positive and nodule-negative controls, and SurePath or CytoLyt cytology from diagnostic procedures. Serum protocols use red-top clotting, timed centrifugation, and a freeze within about four hours; plasma is double-spun and stored at −80 °C. Age windows, smoking history, and washout from systemic steroids, immunosuppressants, or antibiotics are applied when the study requires them.
Fresh surgical NSCLC and colorectal cancer
Fresh NSCLC, and in some programs matched fresh CRC, is recovered in the operating room for same-day or short-interval downstream use. Adults with confirmed primary disease are included; treatment-naive resections are preferred. Tissue is placed in transport media and moved on a defined cold chain rather than being fixed or snap-frozen. Infectious-disease history and pregnancy exclude.
Small cell lung cancer tissue and plasma
SCLC programs include FFPE, fresh-frozen tumor with matched plasma for spatial and single-nucleus work, and marker-selected series such as DLL3-positive cases. Adults with confirmed SCLC are included across stages; treatment status is annotated. Frozen tissue is snap-frozen and held at −80 °C; FFPE follows standard 10% NBF fixation; plasma is EDTA or Streck double-spun. Infectious-disease screens accompany the set.
Pancreatic ductal adenocarcinoma serum
Treatment-naive PDAC serum is collected from adults, typically middle-aged and older, before any cancer-directed therapy. Blood is drawn in plastic red-top serum tubes (not SST), clotted upright at room temperature, centrifuged, and aliquoted into polypropylene cryovials for −80 °C storage. Donors on high-dose biotin are deferred for a washout of several hours. Pregnancy, breastfeeding, HIV/HBV/HCV, and treatment for PDAC or another malignancy in the prior year are excluded.
PDAC FFPE after chemotherapy
Post-chemotherapy PDAC FFPE supports treated-tumor IHC. Adults with confirmed PDAC after systemic therapy are included; blocks are 10% NBF–fixed surgical or biopsy material, stored refrigerated and shipped ambient, with treatment regimen and timing annotated. Infectious-disease history and pregnancy exclude.
PDAC serial PBMC and serum on FOLFIRINOX or gemcitabine/oxaliplatin
Metastatic PDAC patients starting FOLFIRINOX or gemcitabine/oxaliplatin donate serial blood before each cycle from baseline through the early cycles, with a minimum of a pre-cycle-1 draw and two on-treatment draws. Neoadjuvant taxane or anthracycline in the localized setting is acceptable; checkpoint-inhibitor exposure in the months before this line is not. Blood is split into viable Ficoll PBMCs and SST serum, frozen at −80 °C, and optionally paired with a primary-tumor FFPE block.
Frozen viable pancreatic, breast, bladder, and lung tissue
Snap-frozen viable tumor from PDAC, breast carcinoma, bladder cancer, and NSCLC is banked for downstream live-cell or extraction work. Tissue is frozen in LN2 vapor shortly after resection, stored at −80 °C or colder, and shipped on dry ice. Treatment status and histology are annotated; infectious-disease screens are required.
Cholangiocarcinoma FFPE
FFPE from clinically and morphologically confirmed cholangiocarcinoma is provided as surgical or biopsy blocks for IHC. Adults across stages are included. Tissue is 10% NBF–fixed (6–72 h) and shipped ambient with TNM, grade, and treatment status. Pregnancy, breastfeeding, and HBV, HCV, or HIV exclude.
Prostate cancer tissue and longitudinal plasma
Prostate adenocarcinoma collections include multi-time-point tissue or blood series and treatment-naive plasma. Gleason score, TNM, and treatment status are annotated. FFPE follows standard 10% NBF fixation; plasma is EDTA or Streck double-spun and stored at −80 °C. Infectious-disease screens and adult consent apply.
Melanoma FFPE and plasma
Confirmed cutaneous or metastatic melanoma is available as FFPE and as treatment-naive Streck plasma. Blocks are 10% NBF–fixed with standard tumor-content review; plasma is double-spun and frozen at −80 °C. Pathology (subtype, Breslow or TNM as applicable) and infectious-disease screens accompany the material.
Anal squamous cell carcinoma FFPE
FFPE blocks of anal squamous cell carcinoma are selected from surgical or biopsy procedures for IHC. Adults with confirmed diagnosis are included. Fixation is 10% NBF; shipment is ambient with histology and stage. Infectious-disease history and pregnancy exclude.
Urothelial carcinoma before and after immunotherapy
Urothelial carcinoma FFPE, and when specified matched blood, is collected before and after immune-checkpoint therapy so pre- and post-treatment tissue can be compared. Adults with confirmed urothelial carcinoma are included; treatment line and response are annotated. FFPE is 10% NBF–fixed; any plasma is frozen at −80 °C.
Metastatic colorectal cancer liver biopsy with matched blood
FFPE from CRC metastatic to liver is paired with matched plasma and serum from the same donor. Tissue is 10% NBF–fixed biopsy material; blood is processed to plasma and serum and stored at −80 °C. Treatment status, primary versus metastatic site, and infectious-disease screens are included.
Multiple myeloma and AML bone marrow
Hematologic programs include multiple myeloma serum with bone-marrow mononuclear cells, myeloma bone-marrow aspirate FFPE, and AML bone-marrow aspirate FFPE. Adults with confirmed diagnosis are included; treatment status is annotated. Aspirate FFPE is processed as 10% NBF blocks; serum and viable marrow cells are frozen at −80 °C or in LN2 vapor. Infectious-disease screens apply.
Viable PBMC collections
Viable PBMCs are isolated from EDTA whole blood by Ficoll gradient within about 12 hours of draw, counted, viability-checked, and cryopreserved for oncology and immunology studies. Typical inputs are tens of milliliters of blood; aliquots are stored at −80 °C or in LN2 vapor and shipped on dry ice or in a vapor shipper. Indication, treatment status, and infectious-disease screens are recorded. Pregnancy, breastfeeding, and HBV, HCV, or HIV exclude.
Matched FFPE tumor and buffy coat
Banked and prospective sets pair a resection or biopsy FFPE block with a germline buffy-coat aliquot from the same donor. Indications already represented include clear-cell and papillary renal carcinoma, invasive breast carcinoma (with receptor and treatment annotation), papillary and poorly differentiated thyroid carcinoma, and other solid tumors. FFPE is stored ambient with tumor-percentage and necrosis review; buffy coat from K2-EDTA or Streck is held at −80 °C. HIV, HCV, HBsAg, and syphilis results and smoking, alcohol, and comorbidity fields are included when collected.
Multi-indication FFPE inventory
Treatment-naive surgical FFPE blocks are available across colon adenocarcinoma, clear-cell renal carcinoma, lung adenocarcinoma and squamous carcinoma, and high-grade urothelial carcinoma, among other solid tumors. Blocks are 10% NBF–fixed, reviewed for tumor content, and shipped ambient with TNM, grade, and naive treatment status.
Normal control lymph node FFPE
Normal inguinal lymph node FFPE is recovered incidental to hernia-repair surgery for use as a non-malignant control in IHC. Donors are adults without a cancer diagnosis at the node; tissue is processed as a standard 10% NBF paraffin block and shipped ambient with demographics and procedure date.
Cardiac tissue: atrial fibrillation and infarcted myocardium
Cardiac FFPE covers two distinct sources. Surgical left-atrial-appendage blocks from adults with atrial fibrillation and no thrombus are annotated for AF type, anticoagulation, thromboembolic history, and cardiovascular comorbidities. Separately, autopsy ventricular myocardium is collected within about 12 hours post-mortem as normal (no inflammation or fibrosis), acute infarct (necrosis with myeloid inflammation, no fibrosis), or chronic infarct (necrosis without active inflammation), with adjacent viable myocardium required and autolysis minimized. Both are 10% NBF–fixed; H&E images can be reviewed before shipment. Valvular-only tissue is not accepted.
Prenatal cell-free DNA plasma
Maternal Streck Cell-Free DNA plasma is collected in the first or second trimester from pregnancies with a positive carrier screen, an abnormal ultrasound, abnormal NIPT or karyotype, or a fetal variant on microarray or sequencing, including PGD/IVF carrier couples. Egg-donor pregnancies are excluded. About 20–40 mL of blood is drawn in Streck BCT tubes; plasma is frozen at −80 °C. Infant oral swabs, or cord blood or placental/fetal tissue after termination, are collected for follow-up. HBV, HCV, and HIV history exclude.
Celiac disease tissue, PBMC, and serum
Confirmed celiac disease and matched normal-control donors provide a snap-frozen intestinal wedge biopsy, viable PBMCs from roughly 25–30 mL of blood drawn before biopsy, SST serum, and an H&E or FFPE scan. PBMCs are aliquoted at low- and high-million-cell densities. All frozen fractions store at −80 °C and ship on dry ice. Stage and treatment status are annotated; pregnancy, breastfeeding, and HBV, HCV, or HIV exclude.
Systemic lupus, lupus nephritis, and multiple sclerosis PBMCs
Autoimmune collections include lupus biospecimens and paired pre- and post-rituximab PBMCs from lupus nephritis and multiple sclerosis. Post-rituximab draws are timed to B-cell reconstitution or, if reconstitution does not occur, about three months after the last cycle. Blood is drawn in K-EDTA, processed to Ficoll PBMCs within about 12 hours, aliquoted at tens of millions of cells per vial, and stored at −80 °C. Infectious-disease history and pregnancy exclude.
Meibomian gland (meibum) secretions
Meibum is collected from adults with clinically documented meibomian gland dysfunction for lipid and ocular-surface research. Collection follows a site-defined expression protocol; material is frozen and shipped on dry ice. Infectious-disease screens and a clear MGD diagnostic note are requested.
Gastrointestinal metaplasia FFPE
FFPE from clinically confirmed gastrointestinal metaplasia is provided for IHC. Adults are included; blocks are 10% NBF–fixed surgical or biopsy tissue, stored refrigerated and shipped ambient with histology and site of origin. Infectious-disease history and pregnancy exclude.
BAP1-inactivated melanocytic tumors
Skin FFPE from BAP1-inactivated melanocytic tumors, including accepted related diagnoses with documented BAP1 loss, is selected from surgical resections or excisional biopsies of adequate thickness. Minimum tumor and maximum necrosis gates are applied; material older than about 15 years is typically excluded. Blocks are 10% NBF–fixed and shipped ambient.
Grade 3 neuroendocrine carcinoma FFPE and plasma
Prospective sets of FFPE plus matched plasma from grade 3 neuroendocrine carcinomas, excluding small-cell lung cancer, are in scope for studies that need high-grade NEC tissue and liquid biopsy from the same donor. Adults with confirmed G3 NEC are included; FFPE is 10% NBF–fixed and plasma is double-spun and frozen at −80 °C.
NTRK fusion–positive FFPE
FFPE from NTRK1-, NTRK2-, or NTRK3-fusion-positive tumors is sourced across cancer indications when local or send-out NGS documents the fusion. Blocks are 10% NBF–fixed with tumor-content review and ambient shipment. Infectious-disease screens apply.
NF2-altered FFPE
Neurofibromatosis type 2 and NF2-altered tumor FFPE is collected for assay development. Adults with a confirmed NF2-related diagnosis are included; blocks follow standard 10% NBF fixation. When molecular NF2-altered versus wild-type split is not available, clinically confirmed NF2 cases are offered with that limitation stated.
Longitudinal colorectal cancer plasma
Stage II–III CRC plasma can be collected longitudinally at standard-of-care visits, from a treatment-naive or early-treatment baseline through follow-up draws over subsequent years when the donor remains in care. Streck or EDTA double-spun plasma is frozen at −80 °C. Attrition at later time points is expected; remaining visits are still banked. Infectious-disease screens and pathology from the index diagnosis are included.
