Oncimmune's EarlyCDT test met its primary endpoint in a substantial study of lung cancer patients undertaken by the NHS
The primary endpoint was the difference, at 24 months after randomisation, between the rates of patients with stage III, IV or unclassified lung cancer
The company already has European CE mark approval for the EarlyCDT- Lung test and has 18 global agreements in place with a total minimum of £33.5mln sales
In May, the company also announced the start of a major trial in China to test for early-stage lung cancer
At 86.5p share, Oncimmune is valued at £58mln
What the company does:
Specifically, its technology detects evidence of the body's natural response to cancer, enabling detection four years or more before standard clinical diagnosis.
Founded in 2002, it launched its platform technology in 2009, followed by its first commercial tests - EarlyCDT-Lung and EarlyCDT-Liver.
To date, over 155,000 Oncimmune tests have been performed worldwide.
EarlyCDT-Lung was used in the largest-ever trial for the early detection of lung cancer using biomarkers - the National Health Service's Early Cancer Detection Test-Lung Cancer Scotland (ECLS) study of 12,210 high-risk smokers in Scotland.
Oncimmune also develops precision medicine and patient tools that allow doctors to place people being treated for cancer and autoimmune diseases into certain patient sub-groups, a process called stratification.
Scottish NHS study success:
A total of 12,210 Scots were monitored for two years as part of the ECLS initiative in what is believed to be the largest randomised controlled assessment of its kind.
Sponsored by the University of Dundee and NHS Tayside and co-funded by the Chief Scientist Office, the study, to use the scientific parlance, hit its primary end-point.
Specifically, monitoring recruits reduced the incidence of people with late-stage lung cancer, or “unclassified presentation at diagnosis”, compared to standard clinical practice.
What the boss says - Adam Hill, chief executive:
"Lung is the largest market in terms of unmet need in cancer diagnosis today.
“Of those detected, 75-80% are in the late stages where treatment options are limited and survival rates relatively poor.
"One way to tackle this is to detect it earlier in stages one or two, which gives better treatment options."
Last October, Oncimmune outlined a three-year strategy that will see the company focus on its core business of cancer early detection while looking for value- and revenue-enhancing partnerships and acquisitions.
In March it delivered on the acquisitions portion when it bought Protagen Diagnostics for up to £4.11mln-worth of shares. The deal will accelerate Oncimmune's biomarker discovery process and grow its development library to over 8,000 proteins.
Preparations are now underway in Scotland to conduct “a phased population-based” evaluation using EarlyCDT-Lung that would recruit 200,000 people.
The Oncimmune blood test would be supplied on “negotiated commercial terms”, the company said.
A submission of the full ECLS study findings will be made to an unnamed, peer-reviewed medical publication sometime in the next quarter.
And a late-breaking abstract is being prepared for the International Association for the Study of Lung Cancer World Conference on Lung Cancer on 7-10 September 2019 – the world’s largest lung cancer gathering.