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Precision Diagnosis, Classification & Advanced Treatment

Presentation Overview

Hackensack Meridian Health Launches Anthology Diagnostics Laboratories for State-of-the-Art Lab Genomic Profiling of Cancers

POWER OF
PRECISION.

Anthology Diagnostics is at the forefront of a new era in genetic testing. We are actively bringing the power of precision diagnostics into the physician’s everyday practice and patient’s everyday victories.

WHY
PRECISION
DIAGNOSTICS

WHO
WE
ARE

WHAT
WE
DO

WHY
WE’RE
DIFFERENT

HOW
TO GET
STARTED

RESOURCES

WHY
PRECISION DIAGNOSTICS

  • Key to Advancing
    Precision Medicine
  • Evolving
    the Standard of Care
  • Facilitates
    Targeted Therapy
  • Saves Time
    and Cost

PRECISION DIAGNOSTICS:

THE KEY TO ADVANCING PRECISION MEDICINE

The field of precision medicine has evolved rapidly

  • < 250 personalized medicines are available1
  • New drugs are being approved regularly1

Incorporating precision medicine into routine clinical care has been challenging

  • Large and complex datasets
  • Incomplete genomic insights

Advances in precision diagnostics can make everyday precision medicine a reality1

Comprehensive genomic profiling can help

  • Detect disease onset at its earliest stage
  • Target treatments to those patients who will most likely benefit
  • Increase effciency of the healthcare system2
  •  

References:

  1. www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/Research_Program_2021.pdf

2. Pennell NA, et al. Economic impact of next-generation sequencing versus single-gene testing to detect genomic alterations in metastatic non–small-cell lung cancer using a decision analytic model. JCO Precis Oncol. 2019;3:1-9.

COMPREHENSIVE GENOMIC PROFILING:

EVOLVING THE STANDARD OF CARE

Single-gene testing

More >>>

May deliver results that keep
patients from receiving the most
appropriate treatment1

Testing may need to be repeated2
• Delaying treatment decision
• Increasing costs

Hotspot panel testing

More >>>

Do not detect a broad range of
potential alterations3
• Form an incomplete genetic
profile that can impede clinical
decision-making3
• Can miss up to 20% of clinically important mutations in some tumors4

Comprehensive genomic profiling

More >>>

One test can do it all
• Evaluates the most cancer-related genes in a single test in the most accurate and cost-effective manner4
• Shows the sensitivity or resistance of variants to targeted therapy4

References:

  1. Nesline MK, et al. Oncologist uptake of comprehensive genomic prole guided targeted therapy. Oncotarget. 2019;10(45):4616-4629.
  2. Kuo FC, et al. The relative utilities of genome-wide, gene panel, and individual gene sequencing in clinical practice. Blood. 2017;130(4):433-439.
  3. Shah D, et al. ASCO Connection. Hotspot testing versus next-generation sequencing for NSCLC. https://connection.asco.org/magazine/current-controversies-oncology/
    hotspot-testing-versus-next- generation-sequencing-nsclc. Accessed 06/16/2021.
  4. Hess JM, et al. Passenger hotspot mutations in cancer. Cancer Cell. 2019;36(3):288-301.e14.

COMPREHENSIVE GENOMIC PROFILING:

FACILITATES TARGETED THERAPY

Can help ensure patients receive targeted therapy, which can improve outcomes1

Hypothetical example


Reference:

  1. Sorich MJ, et al. Extended RAS mutations and anti-EGFR monoclonal antibody survival benet in metastatic colorectal cancer: a meta-analysis of randomized, controlled trials. Ann Oncol. 2015;26(1):13-21.

COMPREHENSIVE GENOMIC PROFILING:

SAVES TIME AND COST

In an analysis1 of the economic impact of next-generation sequencing (NGS) in metastatic non–small-cell lung cancer (NSCLC) using a decision analytic model

SAVES TIME AND COST

TIME TO RESULTS RECEIPT

Almost 3 weeks saved
NGS – Results in weeks: 2.0
HOTSPOT – Results in weeks: 2.0
EXCLUSIONARY – Results in weeks: 4.7
SEQUENTIAL – Results in weeks: 4.8

SAVES TIME AND COST

TOTAL COST MEDICARE INSURED PATIENTS

Up to $2M saved
NGS – COST (MILLIONS): 2.1
EXCLUSIONARY – COST (MILLIONS): 3.5
SEQUENTIAL – COST (MILLIONS): 3.7
HOTSPOT – COST (MILLIONS): 4.3


Reference:

  1. Pennell NA, et al. Economic impact of next-generation sequencing versus single-gene testing to detect genomic alterations in metastatic non–small-cell lung cancer using a decision analytic model. JCO Precis Oncol. 2019;3:1-9.

WHO
WE ARE

  • Our
    Approach
  • Our People:
    Dr. Ewing
  • Our People:
    Dr. Albitar
  • Powered by
    Genomic Testing Cooperative

OUR APPROACH TO NEXT-GENERATION SEQUENCING

SETS US APART

A complete picture

with comprehensive analysis of both hematologic and solid tumors

Cutting-edge technology

informed by an algorithm that is continually updated with new information as it becomes clinically relevant and validated

Cost-effective solution

with actionable reporting
that can inform decision-making
in everyday practice



SOLID TUMORS
DNA & RNA Testing



HEMATOLOGIC TUMORS
DNA & RNA Testing

OUR PEOPLE ARE OUR GREATEST ASSETS

DR. ALEX EWING

MEDICAL DIRECTOR,
ANTHOLOGY DIAGNOSTICS

Dr. Ewing is Chair, Department of Pathology, and Medical Director of the Laboratories at JFK University Medical Center, where he has served since 2003.

Dr. Ewing received his B.S. degree from Davidson College in 1993, and his M.D. degree from Wake Forest University School of Medicine in 1997.

He completed his residency in Anatomic and Clinical Pathology at Georgetown University Hospital in Washington, DC, in 2001, also serving as Chief Resident.

OUR PEOPLE ARE OUR GREATEST ASSETS

DR. MAHER ALBITAR

FOUNDER, CEO OF
GENOMIC TESTING COOPERATIVE

Dr. Albitar has extensive experience in anatomic/clinical pathology, hematopathology, and molecular pathology.

He also has extensive business and administrative experience as an executive leader of large laboratories, board member, and director of large scientific and genomic diagnostic studies.

Dr. Albitar’s previous experience also includes his position as Senior Vice President, Chief Medical Officer, and Director of Research and Development at NeoGenomics.

POWERED BY GENOMIC TESTING COOPERATIVE (GTC)

We’re proud to be at the forefront of meaningful change for
physicians and patients


  • Founded in partnership with
    Hackensack Meridian Health
    and the GTC to bring
    comprehensive genomic
    profiling for cancer to the local
    New Jersey community and
    East Coast
  • The first lab to utilize GTC’s
    cooperative business model
    to internalize their nextgeneration
    sequencing
    for oncology
  • Participating labs share
    resources, best practices, and
    data; and help each other with
    publication studies

clia
cap

  • Founded in partnership with
    Hackensack Meridian Health
    and the GTC to bring
    comprehensive genomic
    profiling for cancer to the local
    New Jersey community and
    East Coast

WHAT
WE DO

  • Supporting Precision Medicine
  • Informing Clinical Decision-making

Comprehensive molecular profile

• All types of genomic changes (single nucleotide variants, insertions/deletions, copy number variations, fusions)
• Detection of minimal residual disease
• Treatment selection
• Surveillance monitoring for early recurrence

Quality results from small samples

Minimum sample requirements for comprehensive testing
• Bone marrow: 2 mL
• Fresh tissue: 5 microns
• Peripheral blood: 5 mL

Fast turnaround times

• 7 days for DNA
• 10 days for RNA

Clinically actionable reporting

• Customized treatment plans
• Confirmed by clinical pathologist

Variety of sample types supported

• Formalin-Fixed Paran-Embedded (FFPE)
• Peripheral blood
• Bone marrow
• Fresh tissue

Dedicated real-time support

• Expert team of pathologists dedicated to individual
treatment plans
• Physician-staed clinical support to help interpret
lab results

INFORMING CLINICAL DECISION-MAKING

Our testing provides the information that can help
make more informed clinical decisions regarding:

Making a
diagnosis

Identifying a
targeted treatment

Monitoring minimal
residual disease

Payers have potentially overlooked comprehensive genomic profiling as a sophisticated
testing approach that informs complex clinical decision-making and enables a patient’s
next best care option, be it drug therapy or no further treatment.

– Nesline MK, et al.

Reference:

  1. Reference: 1. Nesline MK, et al. Oncologist uptake of comprehensive genomic prole guided targeted therapy. Oncotarget. 2019;10(45):4616-4629.

WHY
WE ARE DIFFERENT

  • State-of-the-Art Innovation
  • Actionable Reporting

STATE-OF-THE-ART INNOVATION

Machine/deep learning meets next-generation sequencing (NGS)

NGS

Utilizing revolutionary genomic sequencing methods

  • Anthology Diagnostics is bringing new advances to this dynamic field with our comprehensive, cancer-specific DNA and RNA testing platforms

Co-Op

We work together to
achieve more

  • Our labs work together with physicians and patients to improve access to cutting-edge
    healthcare
  • We perform on-site genomic sequencing and upload the data to GTC, which uses its algorithms to analyze

AI Machine Learning

Bringing computer science
to laboratories

  • Our artificial intelligence (AI) technology helps us sort through and curate large sets of data
  • This allows us to quickly assess the impact of genomic alterations on a patient’s prognosis, diagnosis, and treatment response

Treatment Teams

World-class pathologists providing personalized treatment plans

  • Utilizing the information gained through machine learning, our team reviews the complete genomic output, including all relevant genetic alterations
  • Our team then creates individual treatment plans, which include personalized targeted therapies, immunotherapies, and clinical trial options

ACTIONABLE REPORTING

Simplified test reports with clear interpretation of results

  • Provides precise diagnosis of disease and subclassification
  • Identifies therapeutic options, including:
    • FDA-approved therapies
    • Therapies currently being investigated in clinical trials
    • Off-label use of therapies approved for other indications
  • Informs clinical actions, including:
    • Detection of minimal residual disease
    • Treatment selection
    • Surveillance monitoring for early recurrence
  • Customized treatment plan from world-renowned
    clinical pathology team


GETTING
STARTED

  • Get Started
  • Clinical Workflow
  • Simple Ordering Process
  • Broad Access & Reimbursement

GETTING STARTED

New customers will need to complete the New Client Information Form to
establish an account

Once registered, opt in to our online portal to:

  • Order Anthology Diagnostics–specific tests
  • Fill out Test Requisition forms
  • Easily search, sort, and review Anthology Diagnostics patient reports

 

Completed forms can be

  • emailed to info@anthologydiagnostics.com or
  • faxed to 732-321-7298

NEW CLIENT FORM

INSTRUCTIONAL VIDEOS

SAMPLE REPORT

CLINICAL WORKFLOW


SIMPLE 3-STEP ORDERING PROCESS

Anthology Diagnostics has simplified the process to incorporate
precision diagnostics into routine clinical care

Step 1: Understand the testing options

  • Both solid and hematologic tumors have a variety of molecular profiling tests available
  • Sample requirements will vary depending on chosen tests

Step 2: Complete the test requisition form*

  • Patient information and history
  • Patient diagnosis
  • Specimen information
  • Test selections

Step 3: Interpret the
final report

Your final report will include:

  • Diagnosis of disease and
    subclassification
  • Therapeutic options
  • Customized treatment plan

*Once this form is complete, Anthology Diagnostics will ship a Collection Kit for tumor sample collection if needed.

BROAD ACCESS & REIMBURSEMENT

Covered by most major insurance plans

  • Reimbursement rates vary by network
  • Currently cover over 132 million lives

Current as of 7/11/2020

RESOURCES

  • Hematology Testing Options
  • Solid Tumor Testing Options
  • Ordering Forms

Hematology

Profile
177
Genes

  • TAT

    5-7 Days

  • Indications

    MDS, CMML, AML, MPN (JAK2, CALR, MPL), MRD, lymphoma, multiple myeloma, other hematologic diseases

    –

  • Sample Type

    Bone marrow,
    Peripheral blood,
    Fresh tissue

  • Sample Requirements

    Bone marrow: 2ml.
    Peripheral blood: 5 ml.
    EDTA tube preferred
    FFPE: 1 H&E slide and 6-10 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative

  • Results Reported

    DNA

  • Diagnostic
  • Therapeutic
  • Prognostic
  • Heterogeneity
  • Clinical Trial Matching

Read More
Learn more about this test

Liquid Biopsy

Hematology Profile
177
Genes

  • TAT

    5-7 Days DNA

  • Indications

    cfDNA – MDS, CMML, AML, MPN, lymphoma, MRD

    –

  • Sample Type

    Peripheral blood

  • Sample Requirements

    Peripheral blood: 5-10 ml.
    EDTA tube preferred
    –

  • Results Reported

    DNA

  • Diagnostic
  • Therapeutic
  • Prognostic
  • Heterogeneity
  • Clinical Trial Matching

Read More
Learn more about this test

Hematology Fusion /

Expression Profile
1408
Genes

  • TAT

    7-10 Days RNA

  • Indications

    ALL hematologic neoplasms:
    Fusion: BCR-ABL1, FIP1L1-PDGFRA, ETV6-RUNX1, PML-RARA, RUNX1-RUNX1T1, ALL-Ph-Like fusions
    Expression: PD-L1, B-cell markers, T-cell markers, myeloid markers, KI67, MYC, BCL2, BCL6, BCL1, BCMA, PAX5
    alternative splicing, Mutations in all 1400 genes

  • Sample Type

    Bone marrow,
    Peripheral blood,
    Fresh tissue

  • Sample Requirements

    Bone marrow: 2ml.
    Peripheral blood: 5 ml.
    EDTA tube preferred
    FFPE: 1 H&E slide and 6-10 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative

  • Results Reported

    RNA

  • Diagnostic
  • Therapeutic
  • Prognostic
  • Heterogeneity
  • Clinical Trial Matching

Read More
Learn more about this test

Hematology

Profile Plus
177/1408
Genes

  • TAT

    5-7 Days DNA
    7-10 Days RNA
  • Indications

    Classification and diagnosis of lymphoma, multiple myeloma, acute lymphoblastic leukemia, acute myeloid leukemia

    –

  • Sample Type

    Bone marrow,
    Peripheral blood,
    Fresh tissue

  • Sample Requirements

    Bone marrow: 2ml.
    Peripheral blood: 5 ml.
    EDTA tube preferred
    FFPE: 1 H&E slide and 6-10 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative

  • Results Reported

    DNA+RNA

  • Diagnostic
  • Therapeutic
  • Prognostic
  • Heterogeneity
  • Clinical Trial Matching

Read More
Learn more about this test
PLUS

Solid Tumor

Profile
434
Genes

  • TAT

    5-7 Days

  • Indications

    All solid tumors:
    Mutations in 434 genes,
    copy number variation and chromosomal structural abnormalities,
    TMB, MSI

    –

  • Sample Type

    FFPE

  • Sample Requirements

    1 H&E slide and 6-8 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative

  • Results Reported

    DNA

  • Diagnostic
  • Therapeutic
  • Prognostic
  • Heterogeneity
  • Clinical Trial Matching

Read More
Learn more about this test

Solid Tumor Fusion / Expression Profile

1408
Genes

  • TAT

    7-10 Days RNA

  • Indications

    ALL Solid tumors:
    Fusion: ALK, ROS1, RET, NTRK1/2/3, FGFR1/2/3/4, BRAF, CIC, EWSR1 and other sarcoma genes
    Expression: PD-L1, MYC, CCND1, MET, FGFR1/2/3/4, Ki67,
    ERBB2, MDM2
    Alternative splicing: MET exon 14 skipping, EGFR vIII , NTRK
    Mutations in all 1400 genes

  • Sample Type

    FFPE

  • Sample Requirements

    1 H&E slide and 6-8 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative

  • Results Reported

    RNA

  • Diagnostic
  • Therapeutic
  • Prognostic
  • Heterogeneity
  • Clinical Trial Matching

Read More
Learn more about this test

Solid Tumor

Profile Plus
434/1408
Genes

  • TAT

    5-7 Days DNA
    7-10 Days RNA
  • Indications

    ALK, ROS1, RET, NTRK1/2/3, BRAF, CIC, EWSR1, PD-L1,
    MET exon 14 skipping and various alternative splicing,
    MET, HER2,
    EGFR amplification,
    PIK3CA, PTEN, AKT1 and RAS

    –

  • Sample Type

    FFPE

  • Sample Requirements

    1 H&E slide and 6-8 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative

  • Results Reported

    DNA+RNA

  • Diagnostic
  • Therapeutic
  • Prognostic
  • Heterogeneity
  • Clinical Trial Matching

Read More
Learn more about this test
PLUS

Solid Tumor

Monitoring
275
Genes

  • TAT

    5-7 Days DNA

  • Indications

    Monitoring therapy,
    resistance and relapse

    –

  • Sample Type

    Peripheral blood

  • Sample Requirements

    Peripheral blood: 5-10 ml.
    EDTA tube preferred

  • Results Reported

    DNA

  • Monitoring
  • Therapeutic
  • Prognostic
  • Heterogeneity
  • Clinical Trial Matching

Read More
Learn more about this test
Liquid Biopsy


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