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GENETIC TECHNOLOGIES LIMITED — Investor Presentation 2021
Sep 12, 2021
65022_rns_2021-09-12_f9337ad7-4abb-484a-83eb-b5718873d6b2.pdf
Investor Presentation
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H.C. Wainwright 23rd Annual Global Investment Conference
13 – 15 September 2021
ASX: GTG NASDAQ: GENE
Authorised by the Board of Directors of Genetic Technologies Limited
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Notice: Forward looking statements
The purpose of the presentation is to provide an update of the business of Genetic Technologies Limited (the Company) ACN: 009 212 328 (ASX:GTG; NASDAQ:GENE). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by the Company and should not be relied upon as an independent source of information. Please refer to the Company’s website and/or the Company’s filings to the ASX and SEC for further information.
The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside the Company’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and the Company’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution.
This presentation should not be relied on as a recommendation or forecast by the Company. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.
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Our Overview
03 01 02 04 05 06 Our Vision & Our Markets Our Acquisition Our Channels & Our Portfolio & Our Capabilities Divisions Innovation Brand Pillars 2021 Overview Prioritising the EasyDNA - Building our Focused on three Executing through cutting Aligning our internal Where are market entry Direct-to-Consumer distinct and target edge innovation and ‘game capability aligned to we now strategy by region growth pathway routes to market changing’ partnerships execution
3
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Unlocking personalised preventative health
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geneType’s brand evolution reflects its commitment to personalised, preventative health care
Unequalled experience
Scientific team leveraging their extensive research track record in breast and colorectal to expand our medical-grade genetic test portfolio into further cancers and chronic conditions
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Leading integrated technology
The sophisticated integration of genomic and clinical risk factors deliver the most complete risk assessments for serious diseases in the world
Relentless innovation
Accelerating the world’s transition to personalised, preventative health care by converting genetic data into actionable solutions for consumers and doctors
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Setting new standards
Setting clinical, safety and ethical standards to ensure the best health outcomes
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Our 2021 Snapshot
Signed multi-year distribution agreement
License and distribution agreement for COVID-19 Risk Test with IBX for minimum of US$2.9 million over 3 years to maintain exclusivity Launched CIT in USA & AUS for other tests[1]
Focused on commercialisation of R&D
Over a decade of R&D translating to commercial launch of geneType for Breast Cancer, Colorectal Cancer & COVID-19
On track to launch new Multi-test
New Multi-test development on track for serious disease risk including major oncological, metabolic and degenerative diseases - covering up to 70% of mortalities and morbidities
Acquired revenue generating platform
Acquired EasyDNA for US$4m in cash and script[2 ] providing global platform with US$4.63m in unaudited revenue in CY20
Solid balance sheet
A$17.6 million pro forma cash balance following settlement of EasyDNA, providing a 24-month runway
Robust patent portfolio & clinical credibility
17 patents granted and 9 patent families pending multiple peer-reviewed publications and four collaborations with prestigious academic and medical establishments
- geneType for Breast Cancer and Colorectal Cancer certified for sale via online sales platform. 2. Runway based on current cash projections and including the acquisition of EasyDNA
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03 01 02 04 05 06 Our Vision & Our Markets Our Acquisition Our Channels & Our Portfolio & Our Capabilities Divisions Innovation Brand Pillars 7
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Our Markets and Collaborators
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United States Europe & UK
geneType® Polygenic Risk Commencing CE certification
Score (PRS) tests for breast, enabling EU launch of Novel
colorectal cancer and COVID- genetic risk test in CY2021
19 Risk Test available through
CLIA Certified “High
Complexity” Laboratories.
EasyDNA available multiple
Further products expected to
EU countries and UK
be submitted in next 12
months
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Australia & New Zealand
Asia
(Inc. SEA, China and India)
H2 CY2021 to commence a Certification by Australian scoping and Prioritising a regulators NATA , to sell into market entry strategy into the Australian market Asia Two products[1] currently certified and further products expected to be submitted in EasyDNA available in multiple next 12 months countries across SEA
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1 GeneType for Breast Cancer and Colorectal Cancer certified for sale via online sales platform.
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A strategy to own the personalised, preventative health testing market
Brand Recognition and Advocacy
Thought leadership
Demonstrating our leadership by informing the conversation on personalised, preventative health care
Seeded content
Amplifying our impact by starting and informing conversations in key consumer and clinical channels
geneType advocacy
Building a group of clinicians and consumers willing to share with their colleagues and friends their experience with geneType
Commercialization and Branding
Sales & marketing
Core set of sales and marketing tactics and assets tailored by therapeutic area, and adapted by geography
Medical education
Motivating trial and purchase with medical education for clinicians and consumers
geneType Hubs
Empowering clinicians to use geneType. Their clinic becomes a geneType Hub that taps into a GP referral network and reinforcing their leadership in personalised, preventative health care
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A cutting-edge geneType brand set for relaunch
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Mobile
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Digital
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Education
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03
01 02 04 05 06
Our Vision & Our Markets Our Acquisition Our Channels & Our Portfolio & Our Capabilities
Divisions Innovation
Brand Pillars
11
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EasyDNA – Acquisition of DTC Platform
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Acquired EasyDNA in August 2021 for US$4 million
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Current revenues of US$4.63 million through retail sales of its athome DNA tests
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Agreements with 12 laboratories in North America, AsiaPac and Europe
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A platform to launch the geneType Multi Test and portfolio of serious disease tests across 40 countries*
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- Subject to local regulatory requirement
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EasyDNA – Establishing our Lifestyle Division
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Headed by Kevin Camilleri
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EasyDNA currently sells paternity, oncology and health and wellbeing genomics-based tests
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This acquisition provides Genetic Technologies the foundation to grow in 40 countries
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Expand the health related tests with an extensive DTC marketplace
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03
01 02 04 05 06
Our Vision & Our Markets Our Acquisition Our Channels & Our Portfolio & Our Capabilities
Divisions Innovation
Brand Pillars
14
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Our Pathways
Medical – Business to Business Consumer initiated testing (CIT) Direct to consumer testing (DTC) (B2B) with medical supervision with no medical supervision A communication Certifying Launched US and Current products Recent Acquisition Provides Genetic and execution plan reimbursable Australia CIT include: announced for Technologies the curated for germline testing platforms in 2020 EasyDNA foundation to grow platform with medical geneType for Breast in 40 countries Payers / Insurers supervision with: Cancer BRCA test Primary Care InTeleLabs in the geneType for Leverage for Agreements with 12 Physicians LYNCH Syndrome US Colorectal Cancer paternity, ancestry, laboratories in test gut microbiome North America, Specialists Phenix Health in AUD$349 / US$249 testing and non- AsiaPac and Europe (More to follow)* Australia per test medical related Surgeons genomic tests Allied Health www.Easydna.com
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- Corporates and Insurance market entry assessment in progress.
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Our Divisions
Emerging divisions Existing divisions
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Germline t esting
BRCA, Lynch
Syndrome and
Somatic testing
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Mental Health
by Taliaz
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Metabolic
diseases
Diabetes
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NEW – Universal collection test kit to support Multi Test Launch
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BC = Breast Cancer; CRC = Colorectal Cancer; PC = Prostate Cancer; CVD = Cardiovascular Disease; IHD = Ischemic Heart Disease; Atrial Fibrillation
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03
01 02 04 05 06
Our Vision & Our Markets Our Acquisition Our Channels & Our Portfolio & Our Capabilities
Divisions Innovation
Brand Pillars
18
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Our Innovation
geneType integrates genetic risk and clinical risk to better stratify individual risk. Patients with potentially high risk may exceed actionable clinical guidelines 10 – 15 years earlier than those with low risk[1,2,3]
Breast Cancer (BC)[1]
Colorectal Cancer (CRC)[2]
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Chronic Heart Disease (CHD)[3]
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Low polygenic risk score High polygenic risk score
geneType detects patients at an actionable risk of serious disease 10 – 15 years earlier than currently possible Potentially significantly improving patient outcomes and health economics
1 Mavaddat et al. (2015) JNCI.
2 Jenkins et al. (2019) Familial Cancer.
3 Abraham et al. (2016) Eur Heart J.
Our Portfolio − Driving Growth
CIT Platform in AUS and USA selling BRC and CRC
IBX COVID Risk Test released for sale May 31, 2021
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Moderate Revenue Expectations Q2 CY 2021
Revenue Commenced Q2 CY 2021
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Expanding into reimbursable
100% Germline + PRS test space
Commercially
for Breast Cancer and CRC Available
to launch in AU & USA Q4 CY 2021
BRCA Lynch
Panel Syndrome
Market Release to include up to 70% of morbidity :
• Breast Cancer
Multi Test to provide risk • Colorectal Cancer Commercially
assessment for >70% of • Cardiovascular Disease Available
all morbidities to launch •• Type 2 DiabetesMelanoma Q4 CY 2021
• Prostate Cancer
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December 2020
April 2021
July H2 2021 2021
20
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Significant market opportunity
To provide predictive, pre-symptomatic testing to inform lifestyle choices and healthcare discussions Guideline driven, reimbursable for inherited and non inherited disease
Near Term Addressable Market
281,550[5] 1[st] degree Diagnosis of breast cancer annually in United States relatives (19,974 cases diagnosed annually in Australia[3] )
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149,500 [6]
Diagnosis of colorectal cancer
annually in United States
(15,494 cases diagnosed annually in Australia [4] )
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1 [st] degree
relatives
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GTG Target Market for
BRCA Panel + Breast Cancer PRS
Testing
providing up to 100% genetic
risk cover screening
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GTG Target Market for
LYNCH Syndrome Panel + Colorectal
Cancer PRS Testing
providing up to 100% genetic
risk cover screening
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Global Predictive Genetic Testing Market anticipated to exceed $28bn by 2026 [1]
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Genetic Testing Market Size By Test Type (Predictive Testing, Carrier Testing, Prenatal and New-born Testing, Diagnostic Testing, Pharmacogenomic Testing, Nutrigenomic Testing), By Application (Cancer, Genetic Disease, Cardiovascular Disease), Industry Analysis Report, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2020 – 2026; Published Date: Feb 2020; Authors: Sumant Ugalmugle, Rupali Swain
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PRS = Polygenic Risk Score
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https://www.canceraustralia.gov.au/affected-cancer/cancer-types/breast-cancer/breast-cancer-australia-statistics
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https://www.canceraustralia.gov.au/affected-cancer/cancer-types/bowel-cancer/bowel-cancer-colorectal-cancer-australia-statistics
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https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html
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https://www.cancer.net/cancer-types/colorectal-cancer/statistics
Our Innovation - Multi Test
A companion diagnostic PRS to help identify risk of serious disease for up to 70% of Mortalities and Morbidities Committed to continually invest in developing multi population testing solutions
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Phase 1 Launch [2]
Oncology GeneType Multi-test to include
Breast Cancer
Phase 2 Launch [3] 1 >70% of mortality & morbidity
Colorectal Cancer
Prostate Cancer
Melanoma
Pancreatic Cancer
Ovarian Cancer
Cardiovascular
2
Atrial Fibrillation
Coronary Artery Disease
Metabolic
Type 2 Diabetes 3
Mental Health
Taliaz 4
NEW Universal sample collection kit with
TGA, FDA and EU regulatory approval [1]
1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek
2. Commercial availability expected Q4 CY2021
3. Commercial availability expected Q1 CY2022
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03
01 02 04 05 06
Our Vision & Our Markets Our Acquisition Our Channels & Our Portfolio & Our Capabilities
Divisions Innovation
Brand Pillars
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Our Capability
Dedicated Innovation Hub
Developing and capturing the next generation of innovation in genomics
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Genetic based
preventative
healthplatform
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Marketing and Positioning
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Enhanced Sales and Distribution
Creating a consumer and patient led infrastructure for a direct to consumer e-commerce and B2B sales platform
Capitalise on Licensing, JV and M&A opportunities Partner with leading commercial labs in regions
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Commercial Finance
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Education and Advisory
Innovation underpinned by controlled operating expenditure
Leveraging partnerships with institutions Oversight and advise to guide ethics and inform innovation
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Enhanced IT infrastructure
Futureproofing our platform
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Internal Structure
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Resourced to deliver with significant medical and business acumen inhouse to continue to drive value
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03
01 02 04 05 06
Our Vision & Our Markets Our Acquisition Our Channels & Our Portfolio & Our Capabilities
Divisions Innovation
Brand Pillars
Focused and
Targeted and Positioned for Cutting edge Aligned to
deliberate growth distinct innovation execute
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Thank you
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Appendices
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Our Intellectual Property
7 Patents granted in the US
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Patent 11,031,098, Computer systems and methods for genomic analysis
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Patent 10,683,549, Methods for assessing risk of developing breast cancer
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Patent Nos. 9,051,617; 9,068,229 and 9,702,011 covering three of the core genetic markers included in the BREVAGenplus® risk assessment test
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Patent No. 7,127,355 offering broad protection re: methods of genetic analysis (the concept of combining clinical risk assessment with genetic risk factors to improve predictability over clinical risk assessment alone)
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Patent No. 6,969,589 covering the identification of informative SNPs
5 Patents granted in China
- Patent Nos. 200680051710.0; 201310524782.4; 201310524916.2 and 201310524765.0 “Markers for Breast Cancer”
9 Patent families pending
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Methods for breast cancer risk assessment
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Methods for assessing risk of developing breast cancer
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Improved methods for assessing risk of developing breast cancer
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Markers for breast cancer
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Methods for genetic analysis
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Methods for genomic analysis
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Methods for assessing risk of developing colorectal cancer
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Methods of assessing risk developing a disease
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Patent No. 201080033130.5 Methods for Breast Cancer Risk Assessment
5 Patents granted in Hong Kong
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Methods for assessing risk of developing a severe response to coronavirus infection
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Patent Nos. 09101235.4; 12112875.1; 12112368.5 and 12112874.2 “Markers for Breast Cancer”
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Patent No. 12109000.5 Methods for Breast Cancer Risk Assessment
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Board and Management: Sales and Scientific expertise leading GTG
Mr. Peter Rubinstein BEc, LLB Chairman - Non – Executive Director
Dr. Lindsay Wakefield MBBS Non – Executive Director
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Mr Nick Burrows B.Com, FAICD, FCA, FGIA, FTIA, F Fin Non – Executive Director
Simon Morriss GAICD Chief Executive Officer
Dr. Jerzy “George” Muchnicki MBBS Executive Director & Chief Medical Officer
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Erika Spaeth PhD Director of Clinical Affairs & Medical Education
Richard Allman BSc, PhD Chief Scientific Officer
Mike Tonroe BSc, FCA, MAICD Chief Financial Officer
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Carl Stubbings Chief Commercial Officer
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Strong Scientific Leadership: Advisory Board
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Professor Jon Emery
MBBCh MA DPhil FRACGP MRCGP Research & Education Lead, Primary Care Integration, Victorian Comprehensive Cancer Centre Herman Chair of Primary Care Cancer Research, University of Melbourne
Professor Finlay Macrae AO
MBBS, MD, FRACP, FRCP, AGAF MWGO is Principal Fellow and Professor, Department of Medicine, University of Melbourne, and Head of Colorectal Medicine and Genetics, The Royal Melbourne Hospital
Ora K. Gordon, M.D.
MD, MS, FACMG
Regional Medical Director, Center for Clinical Genetics & Genomics. Clinical Director, PSJH Population Health Genomics Program. Chair, Integrated Network Cancer Program, Professor of Genetics, St John Cancer Institute
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Corporate Overview
Top 50 share registry breakdown
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Other, 20%
Board &
Management ,
6%
BNY Mellon,
74%
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Defined Terms
Common Complex Diseases (CCP) – A complex disease is caused by the interaction of multiple genes and environmental factors. Complex diseases are also called multifactorial. Examples of common complex diseases include cancer and heart disease.
Polygenic risk score - a number associated with one’s disease risk based on the aggregated effects of individual risk variants through a multiplicative algorithm.
Variant - Single Nucleotide polymorphism (SNP), an alteration in DNA that may be a common or rare event.
Genomic - pertaining to function of genetics from structure to relationship between genetic events.
Genetic - pertaining to a gene.
GWAS - genome-wide association studies are large population level studies which enable scientists to identify genes and genetic markers involved in human disease. This method searches the genome for SNPs that occur more frequently in people with a particular disease than in people without the disease. Each study can look at hundreds or many thousands of SNPs at the same time. Researchers use data from this type of study to pinpoint genetic variations that may contribute to a person’s risk of developing a certain disease.
SNP - Single nucleotide polymorphisms, frequently called SNPs (pronounced “snips”), are the most common type of genetic variation among people. Each SNP represents a difference in a single DNA building block, called a nucleotide. For example, a SNP may replace the nucleotide cytosine (C) with the nucleotide thymine (T) in a certain stretch of DNA.
- Serious Disease Risk (SDR) Risk associated with acquiring COVID-19 and requiring hospitalisation withs its associated morbidities and mortalities.
Germline Testing – Germline testing is done on cells that do not have cancer. It is done to see if a person has a gene mutation that is known to increase the risk of developing cancers and other health problems. This test uses cells (such as blood or skin cells) that do not have any cancer cells. Germline mutations can sometimes be passed down from parents.
Clinical Laboratory Improvement Amendments (CLIA) - Regulates laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing
National Association of Testing Authorities (NATA) - the authority responsible for the accreditation of laboratories, inspection bodies, calibration services, producers of certified reference materials and proficiency testing scheme providers throughout Australia. It is also Australia's compliance monitoring authority for the OECD Principles of GLP. NATA provides independent assurance of technical competence through a proven network of best practice industry experts for customers who require confidence in the delivery of their products and services.
Next Generation Sequencing ( NGS) – Next-generation sequencing (NGS), also known as high-throughput sequencing, is the catch-all term used to describe a number of different modern sequencing technologies. These technologies allow for sequencing of DNA and RNA much more quickly and cheaply than the previously used Sanger sequencing, and as such revolutionised the study of genomics and molecular biology.
Laboratory Developed Tests (LDT) – A type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.
Consumer Initiated Tests (CIT) - laboratory testing that is initiated by the consumer without a physician order but reviewed and communicated back to the consumer via a physician.
Direct to Consumer (DTC) – laboratory testing that is initiated by the consumer without a physician order. The results are reported back directly to the consumer.