Authorisation for EarlyCDT Lung in Brazil

RNS Number : 6213R

Oncimmune Holdings PLC

01 July 2020

 

1 July 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

ANVISA authorisation brings opportunity for EarlyCDT Lung sales in large Brazilian market

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, today announces that its distributor in Brazil, Valentech International LLC ("Valentech"), has obtained marketing authorisation for the EarlyCDT Lung blood test for the early detection of lung cancer in Brazil from Agência Nacional de Vigilância Sanitária ("ANVISA").

Lung cancer is the biggest cancer killer in Brazil; 34,000 people were diagnosed with lung cancer in 2018 and almost 32,000 deaths were reported from the disease in the same year¹. Brazil therefore has a high unmet need for new technologies in the earlier detection of lung cancer and presents a significant market opportunity for EarlyCDT Lung.

This marketing authorisation is effective immediately and enables market access for EarlyCDT Lung in one of the largest addressable markets in the world. Oncimmune signed a distribution agreement with Valentech for Brazil and Colombia in 2018.

Dr Adam M Hill, CEO of Oncimmune said: "Survival rates from lung cancer can be increased significantly with earlier detection of the disease. We are delighted that EarlyCDT Lung can now be made available in this large market, where the need is so great."

^1.   https://gco.iarc.fr/today/data/factsheets/populations/76-brazil-fact-sheets.pdf

For further information:

Oncimmune Holdings plc

Adam Hill, Chief Executive Officer

Matthew Hall, Chief Financial Officer

[e-mail]

Zeus Capital Limited (Nominated Adviser and Joint Broker)

Andrew Jones, Daniel Harris, Victoria Ayton

[phone]

finnCap (Joint Broker)

Geoff Nash, Matthew Radley, Tim Redfern

[phone]

Media enquiries:

FTI Consulting

Ben Atwell, Michael Trace, Alex Davis

[e-mail]

[phone]

About Oncimmune

Our intimate understanding of the human immune system enables us to harness its sophisticated response to disease to detect cancer earlier and to support the development of better therapies.

The key to improving cancer survival is early detection and better selection for therapy. As a company, we are driven by our passion to improve cancer survival and give people extra time. Oncimmune's immunodiagnostic test, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis.

The unique combination of our core technology and understanding of the immune system, powers our ImmunoINSIGHTS service; a proprietary platform that enables life science organisations to optimise drug development and delivery, leading to more effective, targeted as well as safer treatments for patients.

Oncimmune was founded in 2002 and launched its platform diagnostic technology in 2009, followed by the launch of its first commercial tests, EarlyCDT Lung and EarlyCDT Liver. To date, over 200,000 tests have been performed for patients worldwide. EarlyCDT Lung was also used in what is believed to be the largest randomised controlled trial for the early detection of lung cancer using biomarkers, the successful National Health Service (NHS) Early detection of Cancer of the Lung ("ECLS") trial of 12,209 high-risk smokers in Scotland. This trial demonstrated that EarlyCDT Lung reduced the incidence of patients with late-stage lung cancer or unclassified presentation at diagnosis, compared to standard clinical practice.

Oncimmune, headquartered at its laboratory facility in Nottingham, UK, has a discovery research centre in Dortmund, Germany and a partner representative office in Shanghai, China. Oncimmune joined the Alternative Investment Market (AIM) of the London Stock Exchange in May 2016 under the ticker ONC.L.

What is EarlyCDT Lung?

EarlyCDT is a simple blood test that detects the elevated presence of autoantibodies generated by the body's immune system as a natural defence against cancer cells.

EarlyCDT Lung is the world's most thoroughly validated blood test for the detection of lung cancer and requires only a small volume of blood which can be taken using a test in the home or community setting as well as a doctor's surgery. Shown to detect lung cancer on average four years earlier compared to current standard clinical diagnosis, EarlyCDT Lung can also provide an effective assessment of cancer risk in indeterminate pulmonary nodules (IPNs).

For more information, visit  www.oncimmune.com

 

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