Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
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Report on Roche CanadaffAbout the company• F.Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates
worldwide under 2 divisions: Pharmaceuticals and Diagnostics• Founded in 1896 by Fritz Hoffmann-La Rich
• The headquarters are in Basel, Switzerland• In 2020, the company held a revenue of 58.32 billion CHF• They are one of the few companies increasing their dividend every year, for 2018 as the
32nd consecutive year
• Descendants of the founding Hoffmann and Oeri families own slightly over half of thebearer shares with voting rights• Subsidiaries: Genentech (an American biotechnology company), Ventana• They also control the Japanese biotechnology company Chugai Pharmaceuticals• They are the world’s largest spender in pharmaceutical R&D• They are leaders in the ield of cancer treatment, treatment against virus diseases, and fortreatment of metabolic diseases• They have produced a plethora of drugs as well as diabetes management products• Their pipeline• Disease areas of focus:• In lammatory bowl diseases - ulcerative colitis and Crohn’s disease• Cardiovascular and metabolism• Haematology• Haemophilia• Immunology• Infectious disease• Neuroscience - has one of the strongest pipelines in the industry• This is a major focus of R&D at Roche• They are investigating more than a dozen medicines for various diseases of
the CNS• Oncology• Ophthalmology• Rare diseases• Respiratory• Personalized Her• In addition to internal research and development activities, F.Hoffmann-La Roche is also
involved in publicly funded collaborative research projects• Ex in the area of non-clinical safety assessment is the InnoMed PredTox• The company is expanding its activities in joint research projects within theframework of the Innovative Medicines Initiative of EFPIA and the European
Commission

Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5• The company has also demonstrated that they are committed to limiting their impact on
the environment and climate change by proactively seeking new, more sustainable
technologies to achieve this goal
• The company’s long-term goal is to reduce emissions from owned or controlled
sources or from the generation of purchased energy to 0 by the middle of thiscentury• They are also phasing out halogenated hydrocarbons which are very strong GHGs
that signi icantly harm the ozone layer• Their headquarters in Switzerland have implemented thermal networks in the newbuildings to use rejected, or otherwise wasted heat
• They have reduce energy intensity by approximately 40% since 2004
• At their site in Suzhou, China, the solar panel system produces enough electricity
from sunlight to cover almost 80% of the energy needs of the administrationbuilding• The solar power programmes of Genentech, a member of the Roche Group,
make the organization the largest corporate generator of solar energy in the San
Francisco Bay Area.
• The number of drug candidates in pivotal/late stage clinical development has increase by
50% over the past 3years• Breakthrough Therapy Designation is designed to accelerate the development and review
of medicines intended to treat serious or life-threatening conditions with preliminary
evidence that indicates they may demonstrate a substantial improvement over existing
therapiesffStrategy and Mission• Purpose: Doing now what patients need next
• Focus: itting treatment to patients - providing the right therapy for the right group ofpeople at the right timeEugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5• They are working to ensure personalized medicine becomes the norms acrossmainstream, everyday healthcare• They realize they can only achieve this goal through partnerships• They are developing their internal capacities and building strategic partnerships to moveto the next stage of personalized healthcare: to combine insights from multiple data
sources with sophisticated analytics to drive more effective and ef icient research andallow for better therapeutic decisions for patients• Access to their products are a critical part of their strategy• Their detailed access plans are embedded into the business at a local level• They claim they will continue to concentrate their energies entirely on prescription
medicines and in vitro diagnostics rather than diversity into other sectors• Roche is committed to helping countries scale up HIV elimination programs and reach the
WHO 2030 goals of 95% of people on treatment having suppressed viral loads• Roche also strives to help reach the 2030 hepatitis elimination targets of 90% reduction
in new chronic hepatitis B and C cases; 65% reduction in hepatitis-related deaths and
80% of eligible people with chronic hepatitis B and C infections receiving treatmenffProducts/Services
Integrated Core Lab• For nearly 50 years, Roche has provided hospitals and laboratories with the diagnostic
tests and instruments they need to better understand disease and patient biology• Worldwide, their instruments are used to conduct more than 20 billion tests every year
• In the increasingly complex healthcare environment, they offer a new vision: a resolution
in simplicity• Their vision is to empower laboratories to manage the future by streamlining how
they are designed and by simplifying their equipment and processes• The pioneered the ‘Serum Work Area’ - the integration of clinical chemistry andimmunochemistry• Their technology enables a single automated system to conduct a vast array of
testing that gives answers to challenges across the healthcare continuum• They believe that a fully connected laboratory is valuable in expanding theef iciency, scope, and quality of diagnostic capabilities• Less staff time is required to operate the system• Laboratory staff will be free to perform more skilled roles and higher value
work• Will results in cost savings• Providers will be better equipped to meet the emerging needs of individuals• Will generate a wealth of diagnostic data, allowing doctors to provide patientswith holistic, accurate, and precise diagnoses• Will provide faster answers to patients• As a key milestone towards this, they have developed state-of-the-art technology that
consolidates multiple systems in one easy-to-use and fully automated instrument andEugene Consulting Inc.
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offers the broadest range of tests to date in areas as diverse as HIV, hepatitis, oncology,
cardiology, and tests speci ic women’s health in pregnancy and beyond• In 2019, the company expanded their range of assays for the Integrated Core Lab withseveral launches and approvals• They also have important approvals for companion diagnostics in areas such as
Brest and gastric cancer

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Global Access Program• The company created the Global Access Program to help developing countries gain accessto diagnostic tools for prevention and treatment of HIV• They have had major positive impact on diagnosing HIV in low- and middle-income
countries• Since 2104, over 14 million HIV diagnostic tests have reached 82 countries eligible
for access• In collaboration with the Clinton Health Access Initiative and other partners, they provide
accessible and reduced pricing for diagnostic solutions• They offer support programmes that help build healthcare system capacity,
including participation in public-private partnerships• They also invest in developing countries by helping them equip laboratories with
the newest technologies• The cobas Plasma Separation Card was launched in 2018 - it is a stable and easy-to-use
sample collection device for HIV plasma and viral load testing that is the size of a credit
card• With just a small amount of blood from the ingertip, the cobas Plasma Separation
Card allows for reliable quantitative testing of patients with HIV living in renmote
areas - even in places that experience temperatures of 45C and 85% humidity They
aim to ensure that more people in Kenya have access to HIV/AIDS testing Gand viralload monitoring• In 2018, they formally launched a partnership with the Kenya Medical Research Instituteby installing a cobas 8800 for HIV assays• Their public-private partnerships and initiatives like the Roche Scienti ic Campus inSouth Africa demonstrate their ongoing commitment to Africa through capacity building
and skills development• Their aim is that by 2020,90% of all those diagnosed with the HIV infection will receive
sustained antiretroviral therapy and 90% of those receiving this will have viral
suppression• In 2019, the programme was expanded to include tests for HIV-1 viral load, HIV-1 andHIV-2 early infant diagnosis, tuberculosis, hepatitis B and C, and HPV• They also expanded their range of tests with several launches and approvals• 21 billion tests were conducted with Roche produce in 2019
• 100k Roche Diagnostics has a total of more than 100,000 instruments installed inlaboratories, worldwide

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1602- 111 St. Clair Ave W
Toronto, ON
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Phelophepa• Roche and Transnet (the main freight logistics company in South Africa) establishedPhelophepa, which is the world’s irst comprehensive primary healthcare facility on rail
• The 19-coach trains each have 6 clinics on board and are equipped with pharmacies anddiagnostic tools for diabetes and cancer screenings, such as breast examinations, cervicaland prostate cancer checks• They run extensive health education programmes for the local schools, HIV/AIDS andcancer awareness programmes for the surrounding communities, and primary healthcare
training for student doctors, nurses, and pharmacists• They also support the local economy by offering work on the trains in the communities
which they visit• Phelophepa has received the United National Public Service Award for its excellence inpublic service delivery• Roche renewed its support of Phelophepa in 2019
• They are the initiative’s main external sponsor• Roche Healthcare Consulting is a new service established by Roche Diagnostics• They consultant are experts in how to use VR and computer simulations to aid lab
leader’s decision making• With its Advanced, high-quality VR models, Roche Healthcare Consulting now leads
the diagnostic laboratory consulting sector in its use of VR in healthcare• Roche Diagnostics is also pioneering the techniques required to design entire labs
in real-time VR, down to the smallest architectural details and speci ications of each
instrument• The use of VR in hospitals is expected to rise exponentially, with the VR healthcare
market projected to be worth $5.1 billion by 2025

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Roche and Data Science• In July 2020, Roche and its subsidiary Genetech signed a deal with PicnicHealth - astartup that helps patients access and share their medical records• This deal will allow the companies to have access to PicnicHealth’s set of deidenti ied patient records in order to gain insights about certain diseases andtreatments• The deal will focus speci ically on multiple sclerosis• In later years, they are looking at teaming up to study Huntington’s disease,paroxysmal nocturnal hemoglobinuria and hemophilia• This coincide with the news that PicnicHealth is launching a new scienti ic researchplatform that lets patients hare their medical records with researchers• Roche has shown interest in using digital tools for real-world evidence - they stated this is
an important step in their personalized healthcare strategy• In 2017, they acquired oncology EHR software irm Flatiron health for $1.9 billion

Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5• With the goal to shorten time to market for new medicines, Roche employs real world
data, the re-use of clinical trial data along with advanced analytics to be on the cuttingedge of delivering medical solutions and develop R&D innovations for the future
Roche Data Science Coalition• Roche believes that one way the world can win the ight against COVID-19 is by sharing
knowledge and healthcare data to better inform patient care and health system decision
making• To help achieve this, they assembled a group of public and private organizations whoshare this vision• The coalition is dedicated to sharing knowledge and public data and break down the silos
between the people who have access to useful information and the people who can use it
to better understand the crisis• Alberta Machine Intelligence Institute (Amii)• doc.ai• NVIDIA• RGAX• Self Care Catalysts• COVID-19 Health Storylines• ThinkData Works Inc.
• Vector Institute• The Coalition has developed a centralized location with more than 200 curated publicly
available population datasets gathered from sources across the globe to enhance
COVID-19 research• To get this data into the hands of researchers, data scientists, and the community at large,
the Roche Data Science Coalition launched the United Network for COVID Data
Exploration and Research (UNCOVER) Challenge• Administered by the Coalition through Kaggle• They have developed over 100 digital solutions and insights including gAI models,advanced analytics, virtual dashboards, and market reports since its formationff

History of the company• The company was early on known for producing various vitamin preparations andderivatives• 1934 - became the irst company to mass produce synthetic vitamin C un de the brand
name, Redoxon• 1957 - introduced the class of tranquilizers known as benzodiazepines• 1982- the United States arm of the company acquired Biomedical Reference Laboratories
for US $163.5 million• That year, they merged it with all of its laboratories and incorporated the merged
company as Roche Biomedical Laboratories Inc.
• Early 1990 - Roche Biomedical became one of the largest clinical laboratory networks in
the U.S.

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1602- 111 St. Clair Ave W
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M4V 1N5ff• 20 major laboratories and US$600 million in sales• 1992- bought the patent for the polymerase chain reaction (PCR) technique• 1994- Roche acquired Syntex• 1995 - the era of highly active antiretroviral therapy (HAART) was initiated by the U.S
FDA’s approval of their HIV protease inhibitor sanquinavir• Within 2 years of its approval, annual deaths from AIDS in the U.S. fell from over
50,000 to approximately 18,000• April 28 1995 - Hoffman-La Roche sold Roche Biomedical Laboratories Inc. to National
Health Laboratories Holdings Inc. (which later changed its name to Laboratory
Corporation of America Holdings)• 1996 - Roche purchased the rights to Oseltamivir (primary antiviral drug used to combat
bird lu)• Roche is then only drug company authorized to manufacture the drug, which was
discovered by Gilead Sciences• Roche settled a royalty dispute in 2005 - agreeing to pay Gilead tiered royalties of
14-22% of annual net sales without adjusting the payment for manufacturing costs• Soon after, they decided to license other companies to manufacture Oseltamivir• 2002- Roche acquired Chugai Pharmaceuticals• 2005 - acquired the Swiss company GlycArt Biotechnology in order to acquire technology
to afucosylate antibodies• One of its products in development at the time, obinutuzumab, gained FDA approvalin November 2013 for treatment of chronic lymphocytic leukaemia• January 22, 2008 - acquired Ventana Medical Systems for $3.4 billion• January 2, 2009 - acquired Memory Pharmaceuticals For.
• March 12, 2009 - agreed to fully acquire Genentech, which it had held a majority stakesince 1990
• As a result of this, they moved its Palo Alto based research facilities to their campus
in New Jersey• Roche’s United States headquarters was moved to Genentech’s facility in South San
Francisco• Genentech became a wholly owned subsidiary group of Roche on March 25, 2009
• March 26, 2009 - acquired Genentech for $46.8 billion• April 2010 - acquired Medingo Ltd. for $160 million• August 2010 - acquired BioImagene Inc. for $100 million• 2011- the company received the International Society for Pharmaceutical Engineering
Facility of the Year Award for Process Innovation for Roche’s "MyDose" Clinical Supply
project• March 2011 - acquired PVT Probenverteiltechnik GmbH for up to €85 million• July 2010 - acquired mtm laboratories AG for up to 190 million EUR• October 2010 - Racquired Anadys Pharmaceuticals, Inc. for $230 million• December 2020 - announced it would acquire Munich-based Verum Diagnostica GmbH,gaining entry to the fastest-growing ield in the coagulation diagnostics market

Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5f• June 26, 2012, announced the closure of the Nutley/Clifton campus, which was completed
in 2013• July 2013 - Roche Diagnostics acquired blood diagnostics company Constitution Medical
Inc. for $220 million• April 7 2014 - announced its intention to acquire IQuum for up to $450 million, as well as
the rights to an experimental drug (ORY-1001) from Spanish company Oryzon Genomics
for $21 million and up to $500 million in milestone payments• June 2, 2014 - announced its intention to acquire Genia Technologies Inc. for up to $350
million• August 2014 - company agreed to purchase Californian-based pharmaceutical irm
InterMune for $8.3 billion, as well as Santaris Pharma A/S for $450 million• December 2014 - company acquired next-generation sequencing processing company
Bina Technologies for an undisclosed sum• They also acquired Dutalys GmbH, a developer of next-generation anti-bodies• January 16 2015 - announced they would acquire Trophos for 470 million euros in order
to increase the company’s neuromuscular disease presence• The deal entered around on the Phase II and III spinal muscular atrophy drug
olesoxime• April 2015 - acquired CAPP Medical and its chief development of technology for cancer
screening and monitoring via the detection of circulating tutor DNA• August 2015 - company announced its intention to acquire GeneWEAVE Inc. for up to$425 million in order to strengthen its microbial diagnostics business• Days later, the company acquired Kapa Biosystems Inc., which focuses on next
generation sequencing and polymerase chain reaction applications, for $445M• October 2015 - company acquired Adheron Therpeutics for $105 million• Plus up to $475 million in milestone payments• January 2016 - company announced it would acquire Tensha Therapeutics for $115
million upfront, with $420 million in contingent payments• January 2017- company acquired ForSight VISION4• June 2017 - acquired the diabetes management platform, mySugr GmbG for an
undisclosed price• November 2017 - acquired Viewics, Inc.
• December 2017 - announced that would acquire Ignyta Inc. to expand its global oncology
business• February 2018 - announced they would acquire Flatiron Helath, a business specializing in
US cancer data analytics for $1.9 billion• June 2018 - announced it would acquire the outstanding shares of Foundation Medicine
for $2.4 billion• September 2018 - announced its intention to acquire Tusk Therapeutics for up to 655
million euros to expand their oncology pipeline• Tusk announced that the anti-CD38 antibody it is developing will be spun off toform a new company, Black Belt Therapeutics

• November 2018 - announced that Genetech would acquire Jecure Therapeutics which
would allow them to gain access to Jecure’s portfolio of NLRP3 inhibitors developed toight in lammatory disease like non-alcoholic steatohepatitis and liver ibrosis• February 2019 - announced it would acquire gene therapy company, Spark Therapeutics
for US$43 billion• Spark had an already approved treatment for Leber’s congenital amaurosis,
Luxtuma- price edit US$850,000 per patient• The offer to acquire Spark Therapeutics was extended to May 2019 after Roche wasunable garner majority support from Spark shareholders• The company stated that they believe this acquisition will allows Orche tosigni icantly improve the lives of patients through innovative genes therapies andthat this acquisition supports their commitment to bringing transformational
therapies and innovative approaches to people around the world• November 2019 - acquired Promedior and its lead treatment, PRM-151, for the treatmentof idiopathic pulmonary ibrosis for $390 million upfront and another $1 billion inmilestone payments• December 2019 - acquired non-U.S. rights to an investigational Duchenne muscular
dystrophy gene therapy developed by Sarepta Therapeutics• 2019 - launched new cancer medicines Polivy and Roxlytrek• March 2020 - the Rich Diagnostics division reached a signi icant milestone with the FDAapproval of its high-volume SARS-CoV-2 diagnostics test that is capable of analyzing
1,400-8,800 samples within 24 hours on the proprietary cobas 6800/8800 molecular
testing system• May 2020 - announced it had acquired US-based Stratos Genomics for an undisclosed
amount• September 2020 - acquired Ireland-based In lazome, for 380 million euros• This allowed them to gain control of its NLRP3 in lammasome inhibitors• March 2021 - announced it would acquire GenMark Diagnostics for $1.8 billion

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2019-2020 Achievements• In 2019, the company invested about 1/5 of the company’s sales to develop new tests andmedicines for patients in need of new options• In the area of oncology, they are now entering new disease areas with very low incidence
rates such as multiple sclerosis, haemophilia and neuroscience diseases• Of the last 20 medicines that have been approved over the last 20 years, 17 were irst-inclass medicines• Some of their latest innovations are irst-in-class in small-cell lunch cancer and in triplenegative breast cancer• They also offer the irst medicine that can cross the blood-brain barrier to treat a
speci ic type of brain cancer• They have launched 2 medicines in 2019 - a total of 15 since 2012
• They are preparing for the launch of another 2 in 2020

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Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
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Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5• In November 2020, Hoffmann-La Roche Limited (Roche Canada) launched the Roche AI
Centre of Excellence (CoE) with Amii, Mila and Vector Institute• This is the irst collaborative centre to combine the expertise of all 3 national AI
institutes under the CIFAR Pan-Canadian AI Strategy• The CoE seeks to leverage collaboration and specialized expertise to work towardoutcomes such as enhancing access to the right diagnostics and treatments at theright time, informing and de-risking healthcare decision making, elevating andscaling up Canadian AI startups, nurturing AI talent, and bringing science closer tocitizens.
• Roche recognizes the important role AI will play in delivering transformative
solutions, and that only through meaningful partnerships and co-creation will webe able to deliver signi icantly more value to the health ecosystem
2020 Annual Report• Roche has been monitoring and actively minimizing its environmental impact for many
years while growing the business

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• Roche started Flexcare transport in the Philippines to get patients in strict lockdown
areas to get care
• Roche developed an open ecosystem for diabetes care that enables more meaningfulinteraction between people with diabetes and their physicians in response to the need ofdigital technologies due to the COVID-19 pandemic• Developed 15 COVID-19 diagnostic solutions• Roche launched 4 new medicines in 2020
• Venclexta in combination with azacitidine, or decitabine, or low-dose cytarabine forthe treatment of newly diagnosed acute myeloid leukaemia in adults 75 years orolder, or who have comorbidities that preclude use of intensive induction
chemotherapy• A irst-in-class targeted medicine designed to selectively bind and inhibit the
B-cell lymphoma-2 protein• Developed by AbbVie and Roche

Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5• Ecrysdi for the treatment of spinal muscular atrophy in adults and children 2
months of age and older• Gavreto for the treatment of adults with metastatic RET fusion-positive non-small
cell lung cancer• A once-daily, oral precision therapy that selectively inhibits RET-alteredcancers• Genentech and Blueprint Medicines will co-commercialise Gavreto in the
United States• FDA also granted Priority Review to Gavreto for the treatment of people withadvanced or metastatic RET-mutant medullary thyroid cancer and RET
fusion-positive thyroid cancer• Xo luza for the prevention of in luenza following contact with an infected person
FDirst single-dose in luenza medicine approved to prevent in luenza for those whohave had contact with an infected person• 9 new molecules were moved to pivotal clinical studies• There are currently 92 new molecular entities in clinical development• Partnering efforts provided access to 4 late-stage medicines• The GDA approved FoundationONe Liquid Cdx - a pan-tumour liquid biopsy test forpatients with solid tumours analyzing the tumour one more than 300 cancer-related
genes and genomic signatures• They also received FDA approvals for 2 addition companion diagnostic indications:advanced ovarian, breast, and non-small cell lunch cancer• Following the explosion in Beirus on August 4, 2020, Roche contributed to relief efforts bysupporting emergency response and rebuilding initiatives, donating a Roche antibiotic tohealthcare centres, and replacing damaged diagnostic laboratory equipment

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Roche’s response to COVID-19• Roche has developed a number of diagnostics solutions that help to detect and isganose
the infection in patients• A high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19,(FDA Emergency Use Authorisation (EUA) and available in countries accepting the
CE Mark)• A SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence ofantibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)• An IL-6 test to assist in identifying severe in lammatory response in patients with
con irmed COVID-19 (FDA EUA and CE Mark)• Roche v-TAC, which could help simplify the screening, diagnosis and monitoring ofpatients with respiratory compromise in the current COVID-19 pandemi• A SARS-CoV-2 rapid antibody test to help determine at the point of care whether aperson has been exposed to the virus (CE Mark)• A rapid antigen test to support in the detection of SARS-CoV-2 at the point of carewithin 15 minutes (CE Mark)• A high-volume molecular test to simultaneously detect and differentiate between
SARS-CoV-2 and in luenza A/B, as the symptoms are similar for both (FDA EUA andCE Mark)• A second SARS-CoV-2 antibody test, aimed at measuring the spike protein to
support vaccination development and complement our existing portfoli• A point-of-care molecular PCR test that simultaneously detects and differentiates
between SARS-CoV-2 and in luenza A/B infections to support urgent triage anddiagnosis (FDA EUA and CE Mark)• In August 2020, they signed a collaboration agreement with Regeneron on developing
and manufacturing and signi icantly increasing global supply of an investigational
antibody combination for COVID-19 if it proves safe and effective in clinical trials andregulatory approvals are granted• They are also partnering with Atea to jointly develop AT-527, an orally administereddirect-acting antiviral currently in Phase 2 clinical trials• If approved, Roche will be responsible for global manufacturing and distribution
outside the U.S• On September 18, 2020, they announced that the phase III EMPACTA study showed
Actemra/RoActemra plus standard of care reduced the likelihood of progression tomechanical ventilation or death in hospitalized patients with COVID-19 associatedpneumonia compared to placebo plus standard of care
• However, there was no statistical difference in mortality between patients who
received Actemra/RoActemra or placebo• Actemra©/RoActemra© is not approved by any health authority for use in
COVID-19 pneumonia• It will be the irst and only single-agent cancer immunotherapy with three dosing
options, allowing administration every two, three or four weeks, giving physicians
and patients lexibility to manage their treatment.

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Recent News
• March 26, 2021- Roce announced that the European Medicines Agency’s Committee for
Medicinal Products for Human Use has recommended the approval of Tecentriq® as airst-line treatment for adults with metastatic non-small cell lung cancer who tumours
have high PD-L1 expression, with no epidermal growth factor receptor or anapaestic
lymphoma kinase genomic tutor aberrations• A inal decision regarding the approve low Tecentriq is expected in the near future• March 23, 2021 - Roche announced that it obtained approval from the Ministry of Health,Labour, and Welfare for the anticancer agent/antimicrotubule binding anti-CD79b
monoclonal antibody Polivy® intravenous infusion 30 mg and 140 mg [generic name:polatuzumab vedotin (genetical recombination)] in combination with bendamustine(freeze-dried formulation) and rituximab (BR therapy) for the treatment of relapsed or
refractory (R/R) diffuse large B-cell lymphoma (DLBCL)• March 23, 2021 - Roche hosted a virtual Diagnostics Investor Day event• They went over:ffEugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
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1602- 111 St. Clair Ave W
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• Diagnostic market opportunities, strategy, and organization• Overview on R&D and new technologies• Late stage pipeline: Systems and diagnostics locations for selected disease
areas such as infectious diseases, cardiology and oncology• March 18, 2021 - Roche launched DISCOVERY Green HRP chromogen detection kit to
expand immunohistochemistry multiplexing in cancer research• This is their newest addition to the comprehensive collection of modular-based
detection kist to identify and pro ile biomarkers and cell populations in tissuebased research• Roche believes that advanced in the understanding of cancer biology can help pave
the way for improved cancer testing• DISCOVERY Green HRP was designed and developed with researchers in mind andwill enable them to see multiple biomarkers instantly• March 16, 2021 - Roche launched SARS-CoV-2 vVariant 1 Test to detect and differentiate
mutations found in variants that originated in the UK , South Africa, and Brazil• This is a research use only laboratory test which can be used to help scientists track
mutation prevalence• It runs on the widely available, high-volume comas 6800/8800 Systems• March 11, 2021 - Roche was awarded WHO pre-quali ication for the HIV and HCV tests on
the comas 6800/8800 Systems• WHO prequali ication helps regulators and procurers in low and middle-income
countries to identify products that meet high quality standards and are safe andsuitable for their intended use.
• For people who can not easily access healthcare facilities, the ability to simplify
blood collection and sample transportation on a stable device improves access toreliable diagnostics.
• The cobas HIV-1 Test can be used in conjunction with the irst-of-itskind cobas® Plasma Separation Card to process dried plasma spot samples
collected in remote areas, where access to testing facilities can be dif icult.
• Roche is committed to helping countries scale up HIV elimination programs andreach the WHO 2030 goals of 95% of people on treatment having suppressed viralloads• Roche also strives to help reach the 2030 hepatitis elimination targets of 90%
reduction in new chronic hepatitis B and C cases; 65% reduction in hepatitisrelated deaths and 80% of eligible people with chronic hepatitis B and C infections
receiving treatment.
• March 9, 2021 - Roche receives FDA approval for VENTANA ALK (D5F3) Cdx Assay• Approval was given to the VENTANA ALK (D5F3) CDx Assay as a companion
diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients
eligible for treatment with P izer’s drug LORBRENA® (lorlatinib)• It is the only immunohistochemistry (IHIC) test approved by the FDA as acompanion diagnostic for LORBRENA

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• It is no approved as a companion diagnostic in four targeted treatments XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) and
LORBRENA® (lorlatinib)• The VENTANA ALK (D5F3) CDx Assay is available in the US for use on the
BenchMark ULTRA and BenchMark XT immunohistochemistry/in situ hybridisation(IHC/ISH) slide staining instruments• February 11, 2021 - Roche receives irst FDA 510K clearance for urine sample type for BK
virus quantitative test to aid in the improvement of care for transplant patients• A urine sample stabilized in cobas® PCR Media allows the integrity of urine results
to be maintained• The cobas Test runs on the widely available, high-throughout comas 6800/8800
Systems• January 11, 2021 - Roche announced the CE-IVD launch of its automated digital pathology
algorithms, uPath HER2 (4B5) image analysis and uPath HER2 Dual ISH image analysis
for breast cancer to help determine the best treatment strategy for each patient• The image analysis algorithms use AI to support pathologists in making fast,accurate patient diagnosis in breast cancer• uPath HER2 (4B5) image analysis for breast cancer helps pathologists to quickly
determine whether tumours are positive for the HER2 biomarker, highlighting
positively stained tumour cell membranes with a clear visual overlay for easy
reference• th HER2 Dual ISH image analysis for breast cancer assists the pathologist in thedetermination of HER2 gene ampli ication• A heatmap is provided to guide pathologists to areas of interest where thealgorithm can identify cells to inform the determination of a treatment
strategy.
• Validated for use with the VENTANA HER2 (4B5) assay and the VENTANA HER2
Dual ISH DNA Probe Cocktail, the algorithms are ready-to-use and integrated within
the Roche uPath enterprise software.
• December 17, 2020 - Roch is the irst manufacturer to receive an EU Quality Management
System Certi icate• This “EU Quality Management System Certi icate (IVDR)” is mandatory for any
manufacturer of in vitro diagnostic devices (IVDs) to issue declarations ofconformity for their products and to get them (re-)certi ied in compliance with the
new regulation• December 16, 2020 - Roche recieved FDA approval for cobas® HIV-1/HIV-2 Qualitative
Test for use on the fully automated cobas® 6800/8800 Systems in the U.S• The test provides healthcare professionals with a single result to con irm HIV
diagnosis and differentiate HIV-1 and HIV-2• cobas HIV-1/HIV-2 Qualitative for use on the cobas 6800/8800 Systems is an invitro nucleic acid ampli ication test for the qualitative detection and differentiationof human immunode iciency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in humanserum and plasmaEugene Consulting Inc.
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• December 15, 2020 - Launched the cobas® PIK3CA Mutation Test for patients withadvanced or metastatic beast cancer• This in vitro diagnostic test is now available in countries accepting the CE mark• The cobas PIK3CA Mutation Test is a PCR-based test that detects PIK3CA mutations
in patients with metastatic breast cancer to help identify those most likely tobene it from approved therapy• This genetic test identi ies mutations in the PIK3CA gene that can cause cells
to grow uncontrollably, which may lead to cancer• October 31, 2020 - Roche launched cobas prime Pre-analytical System to improve
ef iciency in molecular diagnostics laboratories• This system minimizes repetitive manual tasks, streamlines, and simpli ies
work low in molecule labs
• This reduces manual errors and increases con idence in results• Roche is irst company to offer molecular labs complete end-to-end automation
solution for testing consolidation• October 29, 2020 - Roche received FDA approval of expanded claims for the cobas® EGFR
Mutation Test v2 as a companion diagnostic (CDx) for a broader group of therapies in thetreatment of non-small cell lung cancer (NSCLC)• This claim expansion allows the test to be used as a CDx for all ive currently FDAapproved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordancewith the approved therapeutic product labellinG• This will also enable the test to be used as a CDx for any future approved EGFR TKI
therapies targeting the same mutations, without the need to conduct individual
clinical studies with the test for each new therapy• September 30, 2020 - Roche launched Elecsys® HIV Duo immunoassay in the U.S.
following FDA approval in April 2020
• Through separate measurement of the HIV p24 antigen (the virus) and anti-HIV
antibodies (caused by immune reaction), this test can detect an acute HIV infection
earlier than current methods• The Elecsys® HIV Duo immunoassay detects both the HIV p24 antigen and anti-HIV
antibody• September 16, 2020 - Roche received FDA approval for the expanded use of CINtec®
PLUS Cytology - the irs triage test based on biomarker technology for women whose
cervical cancer screening results are positive for high-risk types of human papillomavirus(HPV)• Additional information from this test supports clinical decisions about which
women will bene it most from immediate follow-up.