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GENETIC TECHNOLOGIES LIMITED Interim / Quarterly Report 2021

Oct 25, 2021

65022_rns_2021-10-25_0efa36d7-16eb-4802-bccd-724e2db756d3.pdf

Interim / Quarterly Report

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Quarterly Business Update October 2021

Authorised by the Board of Directors of Genetic Technologies Limited

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ASX: GTG NASDAQ: GENE

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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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Unlocking personalised preventative health

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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

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Highlights and Results overview – Qtr. 1, 2021

  • Cash receipts of A$850k, a material increase on the prior quarter

Receipts from Customers

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850
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89
Full Year FY21 Actual Q1 FY22 Actual
A$'000
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  • Acquired, settled and integrated the acquisition of EasyDNA, the primary channel for the increase in cash from operations, for US$4 million in cash and scrip

  • Completed and submitted NATA validation pack for the Multi-Test; final step prior to the commercial launch of the Multi-Test

  • Invested in self-funded collaborative study to enable expanded Breast Cancer risk testing for populations of African descent with Professor Colditz at Washington State University

  • Published peer-reviewed paper titled “Ability of known colorectal cancer susceptibility SNPs to predict colorectal cancer risk: A cohort study within the UK Biobank” Gafni A, Dite GS, Spaeth Tuff E, Allman R, Hopper JL (2021) on PLoS

  • Strong cash balance of A$15.7 million, providing 24 months of runway post the integration and revenue contribution from EasyDNA

  • Net cash used for operations of A$1.9 million, due mainly to the increase in R&D and operating expenses as the Company executes on its commercialisation strategy

Results as published on the ASX Monday October 4, 2021

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01: Our 2021 Snapshot

Signed multi-year distribution agreement

License and distribution agreement for COVID-19 Risk Test with IBX 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 African American Breast Cancer Research Collaboration with Professor Colditz at Washington State University

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$15.7million 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

  1. 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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02: 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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Asia Australia & New Zealand
(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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02: 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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02: A cutting-edge geneType brand set for relaunch

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Digital
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Mobile
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Education

02: Core set of sales material to empower clinicians and consumers to trial and use geneType tests

At-a-glance HCP
brochure Guide Book
Patient Management
case studies guide
Clinical Patient
Summaries booklet
Expert Clinic
interviews poster

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03: EasyDNA – Acquisition of DTC Platform

  • Acquired EasyDNA in August 2021 for US$4 million

  • Current revenues of US$4.63 million through retail sales of its athome DNA tests

  • Agreements with 12 laboratories in North America, AsiaPac and Europe

  • 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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03: EasyDNA – Establishing our Lifestyle Division

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  • Headed by Kevin Camilleri

  • EasyDNA currently sells paternity, oncology and health and wellbeing genomics-based tests

  • This acquisition provides Genetic Technologies the foundation to grow in 40 countries

  • Expand the health-related tests with an extensive DTC marketplace

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04: Our Pathways

Direct to consumer testing (DTC) with no medical supervision

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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04: 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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NEW Universal sample collection kit with TGA, FDA and EU regulatory approval[1]

BC = Breast Cancer; CRC = Colorectal Cancer; PC = Prostate Cancer; CVD = Cardiovascular Disease; IHD = Ischemic Heart Disease; Atrial Fibrillation

  1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek

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05: 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.

05: Our Portfolio − Driving Growth

CIT Platform in AUS and USA selling BRC and CRC

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Moderate Revenue Expectations Q2 CY 2021

IBX COVID Risk Test released for sale May 31, 2021

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Revenue Commenced Q2 CY 2021

100% Germline + PRS test for Breast Cancer and CRC to launch in AU & USA

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Expanding into reimbursable
space Commercially
Available
Q4 CY 2021
BRCA Lynch
Panel Syndrome
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Multi Test to provide risk assessment for >70% of all morbidities to launch

Market Release to include up to 70% of morbidity : • Breast Cancer • Colorectal Cancer Commercially • Cardiovascular Disease Available • Type 2 Diabetes Q4 CY 2021 • Melanoma • Prostate Cancer

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December 2020

April 2021

July H2 2021 2021

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05: 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

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281,550 [5]
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1[st] degree relatives

Diagnosis of breast cancer annually in United States (19,974 cases diagnosed annually in Australia[3] )

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GTG Target Market for
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BRCA Panel + Breast Cancer PRS
Testing
providing up to 100% genetic
risk cover screening
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GTG Target Market for
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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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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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  1. 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

  2. PRS = Polygenic Risk Score

  3. https://www.canceraustralia.gov.au/affected-cancer/cancer-types/breast-cancer/breast-cancer-australia-statistics

  4. https://www.canceraustralia.gov.au/affected-cancer/cancer-types/bowel-cancer/bowel-cancer-colorectal-cancer-australia-statistics

  5. https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html

  6. https://www.cancer.net/cancer-types/colorectal-cancer/statistics

05: 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

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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05: Our Innovation - Multi Test Phase 1 Launch Test reports – NATA Validation pack submitted

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Phase 1 Launch [2]
Phase 2 Launch [3]
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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06: 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

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Innovation underpinned by
controlled operating expenditure
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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

Corporate Simon Morriss Genetic Technologies [email protected]

Investor Relations Stephanie Ottens +61 434 405 400 [email protected]

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Appendices

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Our Intellectual Property

7 Patents granted in the US

  • Patent 11,031,098, Computer systems and methods for genomic analysis

  • Patent 10,683,549, Methods for assessing risk of developing breast cancer

  • 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

  • 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)

  • 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

  • Methods for breast cancer risk assessment

  • Methods for assessing risk of developing breast cancer

  • Improved methods for assessing risk of developing breast cancer

  • Markers for breast cancer

  • Methods for genetic analysis

  • Methods for genomic analysis

  • Methods for assessing risk of developing colorectal cancer

  • Methods of assessing risk developing a disease

  • Patent No. 201080033130.5 Methods for Breast Cancer Risk Assessment

5 Patents granted in Hong Kong

  • Methods for assessing risk of developing a severe response to coronavirus infection

  • Patent Nos. 09101235.4; 12112875.1; 12112368.5 and 12112874.2 “Markers for Breast Cancer”

  • 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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Financial Overview

  • Cash burn of A$1.94 million a decrease on prior quarter (Q4 FY’21: A$2.12 million) as a result of product sales, mainly from the EasyDNA brand

  • Cash reserves of A$15.7 million after EasyDNA acquisition costs of A$3.5 million give 24 month runway to:

  • Support the introduction and distribution of new geneType products in the United States and Europe

  • Develop the direct-to-consumer sales channel through EasyDNA

  • Reimbursement studies for the polygenic risk tests;

  • Introduction of germline testing division;

  • General product research and development; and

  • For general working capital and potential acquisitions.

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Corporate Overview

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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.