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LUCYCHANGING THE CANCER

DIAGNOSTIC LANDSCAPE

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The ProblemHOW TO DETECT CANCERS EARLY WHEN

LESS DANGEROUS AND MORE TREATABLE

Size Matters - Tumour size is strongly related to prognosis

Imaging platforms consistently fail in being able to detect early cancers

Early stage cancers are difficult to detect even in a screening programme

Survival and successful treatment is much higher when the tumour is detected early

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LUCY TEST AT A GLANCE

• LUCY is a cancer blood test under development that is based on the detection of a cancer specific proteinlocated on the surface of all cancer cells, that is released into the circulation that serves as a unique molecular indicator of cancer presence. The LUCY test can screen the whole body for all cancer types.

• The LUCY test is being designed to incorporate artificial intelligence to improve the way in which this protein is detected, and to increase the diagnostic scope and appeal of the test .A patent application for the LUCY test has been filed at the US patent office.

• LUCY is a highly sensitive blood test that can detect cancers as small as 1mm – 2mm in size with over 90% accuracy, based on existing test data. The artificial Intelligence component is to automate the test process, and uniquely, is being developed to calculate the size of a detected tumour during analysis, to determine if large enough to be seen in imaging devices, as well as allowing early stage cancers to be monitored.

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LUCY TEST AT A GLANCE

• CURRENT CANCER BLOOD TESTS COMPARISON LUCY detects cancers when 1mm-2 mm diameter size. Blood tests which detect circulating cell-free tumour DNA, can only detect cancers when at least 10mm diameter size. The earliest cancers detected by LUCY will have less than a 3% chance of progressing. Cancers detected when 10mm in size have a 50% chance of progressing. There is no clinical advantage in finding cancers of 10mm, which is above a size that imaging platforms can detect cancers, and hence the need to develop the LUCY test , to fill a diagnostic void.

• COMMERCIAL PRODUCT The LUCY test will comprise an artificial intelligence package that allows the LUCY test to be automated and able to be used on compatible test instruments to generate a cancer diagnosis without the need for specialist human expertise.

• TEST PARTNERS AND COLLABORATORS The LUCY test is being developed by the, National Physical Laboratory and Surrey University. The LUCY test is being offered grant opportunities by CRUK Early Detection Unit, who have full details of the scope and potential of LUCY.

• NOTE Any claims made in this booklet for the LUCY test are predictive for applications and outcomes, prior to human trials being undertaken.

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LUCYA NEXT GENERATION CANCER BLOOD TEST UNDER DEVELOPMENT

BLOOD TEST

One sample one answer Cancer present? Yes/No

EXQUISITE SENSITIVITYLUCY can detect cancers when 1-2

mm diameter size

UNMATCHED ACCURACYDetection rate over 90%

stage zero cancersDetection rate over 99%

stage 1-2 cancers

FALSE POSITIVES

Less than 1%

ARTIFICIAL INTELLIGENCE

Measures cancer size to determine if visible

in imaging devices

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LUCYA NEXT GENERATION CANCER BLOOD TEST UNDER DEVELOPMENT

Extensive supporting evidence

TISSUE OF ORIGIN BLOOD TEST

LUCY test used in advance of tissue of

origin test

WHOLE BODY

LUCY screens the whole body for all cancers

CONFIRMATION

LUCY confirms if cancer free

CLOSING A DIAGNOSTIC VOID

LUCY can detect cancers that other platforms cannot

THE SCIENCE

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Breast Cancer Screening RevolutionAN IN-DEPTH LOOK AT HOW LUCY CAN

BE USED TO DETECT BREAST CANCER

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TEN NEW BREAST CANCER DIAGNOSTIC INNOVATIONS WITH THE LUCYBLOOD TEST

1. LUCY can replace mammography as the gold standard for breast cancer screening

2. LUCY uses artificial intelligence to measure cancer size from 1mm during analysis

3. LUCY can detect cancers in women who have dense breast tissue

4. LUCY can screen women for breast cancer from age 20

5. LUCY can be used to monitor women at risk with defective BRCA genes

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TEN NEW BREAST CANCER DIAGNOSTIC INNOVATIONS WITH THE LUCYBLOOD TEST

6. LUCY is being developed so early breast cancers can be monitored to help prevent over-treatment.

7. LUCY is almost incapable of producing a false positive

8. LUCY screens for other cancers in one test

9. LUCY can tell if cancer free

10. LUCY can be used with a tissue of origin test to confirm location following a positive result

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COMPARING MAMMOGRAPHY WITH LUCY CANCER BLOOD TEST

• 2.5 million UK women have breast cancer screening a year

• Only nine women in 1000 tested have breast cancer

• Tumours need to be at least 7.5 mm in size to be detected in a mammogram

• Most women find mammography uncomfortable

• X-ray exposure has been implicated in studies to increase the risk of breast cancers

• High number of false positive and falsenegative results have serious consequences

• Women have a fear of over-diagnosis and over-treatment including breast removal

• LUCY is a forensic- standard cancer blood test

• LUCY reliably detects cancers when only 1 -2 mm in size

• LUCY screens for breast cancer safelywithout exposure to X-rays

• LUCY is almost incapable of producing a false positive result

• LUCY uses artificial intelligence to measure cancer size to determine stage and if able to be seen in a mammogram

• LUCY can screen women with dense breast tissue

• LUCY screens the whole body and will find other cancers if present

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LUCYAND CANCER THERAPY

• One aspect of the LUCY cancer blood test under development, is that the size of tumours can be calculatedusing AI during the analytical process. This can help to stage cancers and determine treatment options.

• LUCY can replace most invasive and non invasive cancer tests, and as a positive LUCY test is conclusive evidence for cancer presence, a confirmatory tissue biopsy is not required, so treatment is not delayed.

• When used to screen for breast cancers, LUCY can detect cancers when 1-2 mm in size, far earlier than can be confirmed by imaging platforms. LUCY can be used to take snapshots of early cancers so they can be monitored to determine through growth rates whether triple negative that need attention or less active that do not. The benefit is that a confirmatory biopsy will not be required, which would be difficult when trying to locate tiny cancers.

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THE GLOBAL CANCER DIAGNOSTIC MARKET 2020

• The global cancer diagnostic market is segmented on the basis of technology, application and region.

• The cancer diagnostics market is categorized into platform-based and instrument-based, encompassingELISA, ELFA, PCR, NGS, Immunohistochemistry, Microarray, Imaging (MRI, CT, PET, Ultrasound, Mammography, Biopsy), by application (Breast Cancer, Lung Cancer, Colorectal Cancer, Melanoma.

• Based on the application, the cancer diagnostics market is segmented into lung cancer, breast cancer, colorectal cancer, melanoma and others. Breast cancer application is expected to account for a major share of the cancer diagnostics market by application in 2018.

• In total, the cancer diagnostics market’s worth is predicated to be $13.1 billion by 2020.

Source: Market and Markets

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MARKET POSITION FOR LUCYCANCER BLOOD TEST

• The LUCY cancer blood test has the potential to replace all invasive and non-invasive cancer tests.

• This is because LUCY contains multiple innovations in a single test that include; lowest limit of cancer detection of any competing tests; is conclusive evidence for cancer presence when positive ; is being developed to calculate a detected cancer size; replaces the need for a confirmatory tissue biopsy; can be used to monitor cancer status, can replace asymptomatic screening tests such as for breast cancer.

• LUCY will have global appeal in a market that has an annual revenue estimated to be $13 billion by 2020.

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CONTACT DETAILS

Gino Francesco CEOSpecialist Cancer Screening Ltd71-75 Shelton StreetLondonWC2H 9JQGB

CONTACT:

gino@cancercheck.co.uk

PHONE: 07925 35 0088

Copyright Specialist Cancer Screening Ltd 2019

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LUCY IS FOR ANIMALS TOO

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LUCY