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PrecisionMed, inc

Solana Beach, California, US

PrecisionMed, Inc. offers vital products and services facilitating breakthroughs in genetics, drug discovery, biomarker research and molecular diagnostics. We are a leading supplier of high quality, accurately annotated human biological material and we are the largest private global source of longitudinally collected Human Cerebrospinal Fluid from living normal control as well as diseased populations.

Our customers include nearly every major pharmaceutical and biotechnology company, as well as numerous academic, and government research institutions.

In the United States, we focus on prospective longitudinal collections of blood products and cerebrospinal fluid with associated relevant, detailed clinical data. All of our samples are collected in the United States under U.S. IRB approved clinical protocols. Collections span most therapeutic and diagnostic areas. Samples and data are procured through PrecisionMed... Show more »

PrecisionMed, Inc. offers vital products and services facilitating breakthroughs in genetics, drug discovery, biomarker research and molecular diagnostics. We are a leading supplier of high quality, accurately annotated human biological material and we are the largest private global source of longitudinally collected Human Cerebrospinal Fluid from living normal control as well as diseased populations.

Our customers include nearly every major pharmaceutical and biotechnology company, as well as numerous academic, and government research institutions.

In the United States, we focus on prospective longitudinal collections of blood products and cerebrospinal fluid with associated relevant, detailed clinical data. All of our samples are collected in the United States under U.S. IRB approved clinical protocols. Collections span most therapeutic and diagnostic areas. Samples and data are procured through PrecisionMed developed networks of research experienced specialist physician clinical sites.

Neuroscience Program

The neuroscience program covers major neurodegenerative and neuropsychiatric disease and provides our customers with biofluid sample types from difficult-to-reach populations. Within the neuroscience program, there is access to post-mortem brain regions in frozen or formalin format. The program allows for individualized processing and collection of biofluids. Clinical data is detailed and longitudinal with associated longitudinal samples.

Oncology Program

PrecisionMed’s oncology program provides access to US derived FFPE material as well as matched plasma and solid tumor from newly diagnosed patients. When possible, there is up to 5-year follow-up. Another important aspect of our oncology program includes specific sample collections/processing according to individual client specifications.

Collections performed by PrecisionMed have been part of U.S. NIH grants and have formed the basis of U.S. FDA submissions and subsequent U.S. FDA clearance for diagnostics.

We have a strong collaboration with one of the world’s largest tissue banks in Western Europe. Through this partnership we have access to a wide variety of accurately annotated tissue samples as well as the ability to undertake prospective tissue collections.

Samples and clinical data supplied by PrecisionMed are handled in accordance with the highest ethical standards and in strictest compliance with all applicable rules and regulations including the recommendations of the Council of the Human Genome Organization (HUGO) Ethical, Legal, and Social Issues Committee (HUGO-ELSI, 1998); with the United Nations Educational, Scientific, and Cultural Organization’s (UNESCO) Universal Declaration on the Human Genome and Human Rights (1997); and with recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions.

With our background and expertise in human sample procurement, PrecisionMed is uniquely positioned to provide a comprehensive approach to meet the research needs of pharmaceutical and biotechnology companies. PrecisionMed conducts sample procurement studies from collection concept to banked samples in record time.

Founded in 1994, PrecisionMed is located in San Diego, California.

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PrecisionMed, inc has not listed any services.

Human Biobanking
Price on request

Prospective Biological Sample Collections for discovery and/or development

We provide sample collection services from collection concept to banked samples, for single-center or multi-center collections. These services apply to all disease areas including cancer biomarkers.

Biospecimen Management

We provide biobanking... Show more »

Prospective Biological Sample Collections for discovery and/or development

We provide sample collection services from collection concept to banked samples, for single-center or multi-center collections. These services apply to all disease areas including cancer biomarkers.

Biospecimen Management

We provide biobanking and sample management services. Sample collection kits are assembled and shipped to sites. Samples are received, logged, processed and stored in our repository and distributed to testing sites as required.

General Biobank Consulting

Our consulting services cover most aspects of sample collection and banking for biomarker discovery and development. They include biomarker project feasibility and timing, remote clinical site identification and qualification, sample collection kit design, sample management SOPs and sample collection clinical protocol design.

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Clinical Development Strategy
Price on request

CLINICAL TRIAL AND REGULATORY AFFAIRS CONSULTING

Drawing on many years of experience, we provide advice to clients on clinical trial design, implementation and management through all stages, from conception to completion.

We also provide regulatory consulting which covers biomarker development and biomarker clearance... Show more »

CLINICAL TRIAL AND REGULATORY AFFAIRS CONSULTING

Drawing on many years of experience, we provide advice to clients on clinical trial design, implementation and management through all stages, from conception to completion.

We also provide regulatory consulting which covers biomarker development and biomarker clearance strategies, Good Clinical Practice (GCP), Institutional Review Board (IRB) submissions, Presentation Coaching and FDA interaction relating to cancer and other biomarker development.

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Human Tissue Procurement
Price on request

FFPE/Frozen/Fresh Tissue Samples

• US sourced diseased and TruNormal® solid tissue.
• Most diagnoses are available.
• All of our material is well annotated.
• Diseased/tumor and adjacent normal tissues from a single donor are immediately available in formalin fixed paraffin embedded (FFPE) format.
• Snap frozen is... Show more »

FFPE/Frozen/Fresh Tissue Samples

• US sourced diseased and TruNormal® solid tissue.
• Most diagnoses are available.
• All of our material is well annotated.
• Diseased/tumor and adjacent normal tissues from a single donor are immediately available in formalin fixed paraffin embedded (FFPE) format.
• Snap frozen is available but is limited.
• Fresh material is collected prospectively from ongoing clinical protocols.

Slides/Wet Tissue
Not only do we provide slide preparation for your routine H&E, IHC, FISH, etc. we also provide wet tissue with ample tumor sections. In addition to our menu of services, we also provide tissue curls for your molecular study needs.

FFPE Tissue
US-sourced diseased and TruNormal® FFPE material. Most diagnoses are available.
• All of our material is well annotated.
• Diseased/tumor and adjacent normal tissues from a single donor are immediately available in formalin fixed paraffin embedded (FFPE) format.
• Snap frozen is available but is limited.
• Fresh material is collected prospectively from ongoing clinical protocols.
• All material is either consented or supplied under “waiver of consent”.
• All material is supplied by our fully-owned subsidiary, California Tissue Consortium.

Information About Sourcing of Tissue Samples
Samples and clinical data supplied by PrecisionMed, Inc. are handled in accordance with the highest ethical standards and in strictest compliance with all applicable rules and regulations including the recommendations of the Council of the Human Genome Organization (HUGO) Ethical, Legal, and Social Issues Committee (HUGO-ELSI, 1998); with the United Nations Educational, Scientific, and Cultural Organization’s (UNESCO) Universal Declaration on the Human Genome and Human Rights (1997); and with recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions.

Our customers include nearly every major pharmaceutical and biotechnology company, as well as numerous academic, and government research institutions.

Diseased/tumor and adjacent normal tissues from a single donor are available in formalin fixed paraffin embedded (FFPE) and/or snap frozen formats. Various combinations of tissue are available including matched tissue/biofluid sets.

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Matched Human Plasma and Tumor Tissue Samples
Price on request

Plasma and matched resected tissue from solid tumors (Liquid biopsy)

This multicenter clinical protocol, conducted in the United States is designed to collect blood, urine and solid tumor material as well as clinical data from prospectively consented donors with known solid malignant tumors including NSCLC, breast cancer... Show more »

Plasma and matched resected tissue from solid tumors (Liquid biopsy)

This multicenter clinical protocol, conducted in the United States is designed to collect blood, urine and solid tumor material as well as clinical data from prospectively consented donors with known solid malignant tumors including NSCLC, breast cancer and colon cancer and others. Samples, as well as clinical information are de-identified. Clinical data is collected over the course of the disease for up to five-years. There may also be intermittent collection of plasma and urine samples over the five-year period.

• Prospectively consented. Five-year follow-up.
• Banked Material–Breast cancer, NSCLC
• New collections: colorectal cancer, prostate cancer, others.
• Matched plasma and tissue samples with detailed clinical data are available.

Prospectively consented plasma and serum from many tumor types.

• May be paired with tumor tissue (contact us to check).
• Detailed clinical data

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Fixed Human Tissue
Price on request

Human Postmortem Brain Tissue

Post Mortem brain regions clinically characterized: Alzheimer’s disease and controls

• Fixed in 10% NBF
• FFPE (we will make the blocks for you from frozen or formalin fixed material)
• Frozen

Human Postmortem Brain Tissue

Post Mortem brain regions clinically characterized: Alzheimer’s disease and controls

• Fixed in 10% NBF
• FFPE (we will make the blocks for you from frozen or formalin fixed material)
• Frozen

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Alzheimers Disease
Human Cerebrospinal Fluid (CSF) Samples
Price on request

CSF Samples

Our CSF biorepository consists of CSF, CSF cell pellet, PAXGene RNA, serum, plasma, and blood cell pellet collections from diseased and TruNormal® donors, with associated detailed clinical data corresponding to each donor visit. Collections of diseased and TruNormal® CSF comprise samples from various age groups... Show more »

CSF Samples

Our CSF biorepository consists of CSF, CSF cell pellet, PAXGene RNA, serum, plasma, and blood cell pellet collections from diseased and TruNormal® donors, with associated detailed clinical data corresponding to each donor visit. Collections of diseased and TruNormal® CSF comprise samples from various age groups and visit formats. New donors, repeat visits for existing donors as well as additional disease types are regularly added. All CSF is collected in the United States under IRB approved protocols. PrecisionMed, Inc. performs custom CSF collections and custom CSF processing.

Banked CSF diseases

• Alzheimer’s disease ¹ ²
• Mild cognitive impairment ¹ ²
• Parkinson’s disease ¹
• Major depressive disorder
• Amyotrophic lateral sclerosis ²
• Multiple sclerosis ²
• Diabetic neuropathy ²
• Multiple system atrophy
• Schizophrenia ²

¹ Matching CSF biomarker data is supplied when available with AD, MCI, PD and older
controls.
² Multiple visits

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Clinical Research
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Clinical Trials, Consulting, and Management
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Biology
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Cells and Tissues
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Biospecimens
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Human Biospecimen Collection
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Biospecimen Management and Storage
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Human Biospecimens
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Human Biofluids
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Human Tissue
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2018-04-02 11:08:12 -0500

Net Promoter Score of 8 received for Human Tissue Procurement.

Additional Ratings: satisfaction with deliverable: 8, satisfaction with timeliness: 6.

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