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THE PROMPT PARTNER IN BIOTEC RESEARCH.

Genoma partners with organizations dedicated to innovation in human tissue
research. Using the partners’ scientific and clinical expertise, we have
developed global collaborations and have implemented protocols for obtaining,
handling, processing and analysis of human specimens worldwide. The primary
focus of clinical trials are oncology, including solid tumours and hematologic
malignancies; but we also conduct projects in neurology, inflammation, metabolic
and cardiovascular diseases, maternal health and infectious diseases.

Learn More


OUR SERVICES


HIGH QUALITY FIXED TISSUE SPECIMENS FOR RESEARCH

Genoma BioBank provides access to thousands of ready-to-go fully consented or
consent exempt archival FFPE samples. These specimens have been prepared in
strict compliance with our standard operation procedure (SOP) requirements and
according to our ISO13485 certified Quality Management System for medical
devices.
Our standard procedure implies a small piece of human tissue to be prepared by a
certified medical pathologist, submerged in 10% neutral-buffered formalin for 18
– 24 hours, and embedded in IHC-grade paraffin. The target FFPE specimen will
generally allow preparation of 100+ sections and have at least 5×5 mm2 size, but
it can vary significantly depending on the nature of the disease and tissue
type. The fixation agent and the embedding media can be customized upon request
in prospective collections.


FRESH FROZEN TISSUES FOR RNA, DNA AND PROTEIN WORK

Genoma Biobank and Network provides access to fully pre-screened and consented
human samples in the FF (Fresh-Frozen) tissue format. These specimens have been
prepared in strict compliance with our standard operation procedure (SOP)
requirements and according to our ISO13485 certified Quality Management System
for medical devices.
Our standard procedure implies a a small piece of tissue prepared by a certified
medical pathologist is snap-frozen in liquid nitrogen within 30 min after the
surgical excision. A standard sample weighs 100 – 500 mg on average and is
supplied in a standard 2 ml cryovial. An embedding media (like RNA preserving
additives) can be added upon request in prospective collections; a mirroring
FFPE block to represent the frozen tissue may be available.


FROZEN BONE MARROW ASPIRATES

Bone Marrow aspirates of 0,5 to 3 ml and/or bone marrow trephine biopsies are
obtained from patients with hematologic malignancies. The specimens are
snap-frozen and supplied in standard cryovials as 0,5 or 1 ml aliquots.
Subcellular fractions from bone marrow aspirates (including viable frozen cells)
can be prepared per customer request. Available specimens are focused on, but
not limited to:
o Solid Oncology: Tumour and Adjacent Normal Tissues, blood and blood
derivatives
o Hematologic Oncology (AML, CML, ALL, AML, MM, MDS): Bone marrow, blood and
blood derivatives
o Inflammation and Autoimmune Diseases: Skin, Synovial tissue, blood
derivatives, others
o Neurological Diseases: Tissue and blood derivatives for diseases of CNS and
peripheric neurons
o Normal Controls: Various matching tissue samples from otherwise healthy
patients in other indications; blood derivatives from healthy controls and bone
marrow aspirates from non-malignancy conditions.


FRESH SPECIMENS

Genoma provides surgical tissues to be delivered in best non-frozen cold
ischemic conditions to most places in Europe and Middle East in 24 hours of
removal. Accompanying whole blood or blood derivatives may also be available in
a non-frozen form. Our standard operation procedure (SOP) requirements are
strictly applied for best viability, but custom procedures can be followed in
collection, processing or transportation.
Fresh tissues are always delivered to address using a special courier to
address, as all customs procedure is completed in delivered duty paid (DDP)
form, if not requested otherwise.


LOGISTICS AND CUSTOMS PROCESSING

Delivery of all specimens, either shipped ambient or frozen in dry-ice is
organised in a way that recipient will have a minimum or no document work at
all, including the customs processing in the final country, at the time of
delivery. Specimens are delivered using an expedited courier service for
delivery in 1-3 business days to most places in the world. Customisation for
delivery procedure is also possible.
Fresh tissues are always delivered to address in 24 hours, using a special
courier to address, as all customs procedure is completed in delivered duty paid
(DDP) form, if not requested otherwise.


FROZEN WHOLE BLOOD AND BLOOD DERIVATES

Whole blood from Genoma Biorepository is supplied as a 2 – 10 ml frozen blood
sample in a standard K2-EDTA tube. Serum/Plasma is obtained from whole blood
using standard blood fraction separation procedures provided by collection tube
manufacturers. The anti-coagulation agent can be adjusted to customer request in
prospective collections.
The specimens are generally supplied as snap-frozen aliquots of 0,5 or 1 ml in
standard 2 ml cryovials. Subcellular fractions from blood (including viable
frozen cells) can be prepared upon request. Also, other tubes and packaging are
available upon request.


VIABLE CELLS

Genoma also provides specimens of peripheral blood and bone marrow mononuclear
cells (PBMC and BMMC) or dissociated solid tumour cells that have been prepared
in strict compliance with our standard operation procedure (SOP) requirements to
achieve best viability. Custom procedures can also be applied.
Our standard procedure for mononuclear cells implies processing and freezing of
specimens in 2 hours of collection, maintaining a 95-98% viability proven by the
standard Tryphan Blue counting method. Viable mononuclear cells are available as
5 Million cells per ml in a suspension of a cell banking medium. Viable tumour
cells are available in various forms and rates depending on the nature of the
tissue and disease. Procedures or media can be adjusted to project needs in
prospective collections.


MEDICAL DATA

Medical Data always complements the biospecimens in Genoma BioBank. Various
demographic data, medical records of patient including disease background,
details of the condition, treatment history, family history may be available or
can be acquired in prospective collection based projects. A complete pathology
report is always available for tissue specimens and other reports like
diagnostic imaging studies may be provided.
Medical data is always handled pursuant with the The Regulation (EU) N°910/2014
on electronic identification and trust services for electronic transactions in
the internal market (eIDAS Regulation), ISO/IEC 27001:2013 Information
Technology Security Techniques, IMS Requirements and ISO22301:2019 Security and
resilience, as well as Turkish Personal Data Protection Law no. 6698.


SPECIMEN SETS

Specimen sets accompanying frozen or fixed tissues or bone marrow aspirates,
including preoperative and postoperative serum/plasma or whole blood, as well as
viable PBMC or BMMC could be available.
Most fresh frozen tissue samples can be ordered with their matching FFPE block.
Some samples also have their frozen preoperative blood derivatives.
Most FFPE blocks can be ordered with their adjacent normal tissue (ANT)
specimens. Any prospective collection can be customised for collection of
multiple specimens and data from same source. Matching controls can be acquired
from healthy or otherwise healthy individuals of same sex and ±2-5 years age.


COMPLETE TRACEABILITY

Genoma BioBank provides a game changing approach for identifying the banked
biospecimens. All history of the specimen, including origin of the specimen, the
collection and processing date and times, applied SOPs for collection, storage
and transportation, ethical approval documents, customs documents; as well as
the complete available data about patient, diagnosis and follow-up can be
reached by simply reading the unique barcode on an individual cryovial,
collection tube or tissue cassette.


OTHER HUMAN BIOSPECIMENS

Genoma Biobank works closely with principal investigators and project managers
on developing custom protocols, conducting feasibility studies and managing
biospecimen acquisition projects. Specimen acquisition protocols for the
collection of clinically defined biospecimens also include the following
indications:
Metabolic Diseases: Diabetes Mellitus (Type I and Type II) collection of
diabetes blood, serum, plasma samples from patients with defined clinical
criteria. Gynaecologic Conditions: Collection of endometrium and ectopic
endometrium biopsies from patients with confirmed endometriosis and from a
non-endometriosis control group, collection of cervical or vaginal swaps or
vaginal bleeding samples. Cardiovascular Conditions: Atherosclerosis, Myocardial
Infarction, Cardiac Failure, Coronary Artery Disease matched serum samples, as
well as surgical tissue specimens as available. Maternal and Fetal Health: Early
non-invasive diagnosis studies and preterm birth or genetically inherited
conditions registries. Clinical outcome data are also available for longitudinal
collections.


CUSTOM PROJECTS

Genoma BioBank works closely with our customers to create a unique custom study
design for every custom biobanking protocol allowing to achieve specified
research objectives in the evidence-based and a cost-effective manner. We
prioritise ethical, medical, and technical considerations including patient
enrolment criteria, sample format and preparation, data collection and database
entry methods. In addition, our protocol development experts will ensure that
your study will be scientifically rigorous and meet the Ethical Committee’s
requirements in the applicable jurisdictions. We have worked with the following
protocols in the past:
o Drug RnD – from Discovery to Preclinical models
o Diagnostics – from Biomarker discovery to Companion Diagnostics
o Medical devices – from concept to clinical testing We are committed to apply
your study design considering all your needs for Study Objectives (SOW), project
specifications (Inclusion/Exclusion criteria; HBS specifications; laboratory HBS
processing protocols), clinical data (de-identified general medical history and
laboratory tests data; project specific CRF; DB); logistics, deliverables, and
timelines; budget and payment schedule.


ABOUT US

The cardinal component of a clinical validation is no doubt the patient and his
biological specimens. But, biological specimens are only valuable when they are
linked to their clinical data. The more parameters (gene expression status,
protein expressions, mutations,…) known about the patient and the specimen, the
more it is valuable. Organizing physicians and surgeons for collaboration in
clinical trials, managing the IRB approval, collection and transport of the
specimens and disclosing as many clinical parameters in them is one of the
services that can be ordered through Coral Biotec. CoralBiotec partners with
research organizations for a worldwide net for human clinical studies. Clinical
consultancy on international collaborations, project planning, custom protocols
and feasibility as well as retrospective and prospective biospecimen collection
and handling services and a wide range of research purpose laboratory and
molecular laboratory analyses are offered.

Genoma partners with organizations dedicated to innovation in human tissue
research. Using the partners’ scientific and clinical expertise, we have
developed global collaborations and have implemented protocols for obtaining,
handling, processing and analysis of human specimens worldwide. The primary
focus of clinical trials are oncology, including solid tumours and hematologic
malignancies; but we also conduct projects in neurology, inflammation, metabolic
and cardiovascular diseases, maternal health and infectious diseases.




CONTACT US

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