EarlyCDT®

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EarlyCDT®

EarlyCDT® cancer detection tests are based on the presence in the blood of autoantibodies against specific tumour associated antigens that have the potential to detect cancer up to four years earlier than other methods. CT scanning is the gold standard for lung cancer screening. CT screening has high sensitivity if repeated annually. but poor specificity and low positive predictive value (PPV) and accuracy.  As a simple blood test, EarlyCDT®-Lung can be used when a patient is at increased risk of lung cancer or for those patients who are unwilling or unable to commit to annual CT scanning. Intervention in the early stage of disease, while it is still localised, improves the 5-year survival rate for lung cancer by more than 3 times to 56% of patients.

EarlyCDT® — Lung measures blood levels of a panel of seven autoantibodies to tumourassociated antigens that are linked to lung cancer. The seven autoantibodies have been shown to be elevated for all types of lung cancer, and from the earliest stage of the disease. Unlike the tumour antigens themselves, the autoantibody levels can be measured easily and accurately, based upon the signal magnification created by the body’s immune response to cancer. The test runs on a simple enzyme-linked immunosorbent assay (ELISA) platform, which is widely available in hospital laboratories around the world.

More than 155,000 tests have already been performed for patients worldwide, which represents tests ordered by more than 2,000 clinicians. EarlyCDT®—Lung detects all types and stages of lung cancer and has led to the detection of numerous early stage lung cancers. EarlyCDT®—Lung is now available in many countries. Please see the list of test providers at https://earlycdt.com/

  • Clinical Research
EarlyCDT®–Lung test has undergone extensive scientific and clinical validation studies
  • Early stage screening
EarlyCDT®—Lung can be used to detect lung cancer early, in high-risk patients
  • Public Health Programs

Over 150,000 commercial tests have been sold

  • Patient Advocates
EarlyCDT®-Lung can be used for those patients who are unable to commit to annual CT scanning

Facts on Lung Cancer:

Early detection of lung cancer enables earlier intervention and saves lives

  • Almost 80% of lung cancer is diagnosed after it has spread to other organs
  • 19% 5-year survival rate when cancer left untreated
  • Early diagnosis more than triples the 5-year survival rate to 56% if the tumour is found to be localised, but unfortunately, only 16% of lung cancer are diagnosed while still localised
  • 52% of patients die in the first year after diagnosis
  • Lung cancer tends to be diagnosed when symptoms become apparent; by this time the tumour is often at an advanced stage (III or IV)

Freenome

Since theirs beginning in 2014, Freenome has had a clear vision — to build a multi-disciplinary team with expertise in computational biology and machine learning to detect cancer in its earliest, most treatable stages.

In 2023 Freenome acquired Oncimmune, which pioneered the development of autoantibody assay technologies that have the potential to allow cancer detection up to four years earlier than other methods and can be applied to a wide range of solid tumour types.

In 2009, EarlyCDT®️ was launched, a proprietary platform technology for early cancer detection. The first test, EarlyCDT®️-Lung, was commercialised in 2009 and test marketed until 2012, at which time it launched nationally across the US and since then over 150,000 commercial tests have been sold. It is now available through physicians in the US and also privately in the UK and other regions.

EarlyCDT®️-Lung is a simple blood test which is ordered by a doctor to aid in the risk assessment and early detection of lung cancer in high-risk patients and to stratify indeterminate pulmonary nodules for the risk of malignancy.

At Freenome, they aim to empower everyone to prevent, detect, and treat disease by developing high-quality diagnostic tests.

They are dedicated to continuous innovation and improvement in all aspects of our business and accomplish our quality objectives by maintaining an effective quality management system.

Frequently Asked Questions

Lung test is recommended for use in humans who are at high risk of lung cancer due to a combination of age, gender, smoking history and other risk factors such as environmental exposures (dust, asbestos, radioactive substances), those with a history of emphysema/COPD, or family history of lung cancer in a first degree relative.

EarlyCDT®—Lung is a simple and affordable blood test that measures seven proteins, known as autoantibodies, that are linked to the presence of lung cancer. These autoantibodies can be elevated very early in the formation of cancer and can therefore aid in its detection, even before symptoms appear.

The EarlyCDT®—Lung test is designed for people at high risk of lung cancer. High risk means you should be:

  • Aged 50 or over with at least a 20 pack-year smoking history (equivalent to smoking 1 pack of cigarettes per day for 20 years, or 2 packs per day for 10 years); or
  • Aged 40–49 years with at least a 20 pack-year smoking history and at least one additional lung cancer risk factor such as family history, COPD or emphysema, or exposure to environmental risk factors including asbestos, radon, smoke, etc.

The EarlyCDT®—Lung test is not suitable for you if you have ever had any type of cancer other than basal cell carcinoma

Of all the cancers, lung cancer remains the number one killer globally. Every year the disease accounts for 2.09 million new diagnoses and 1.76 million deaths.1 Nearly one in five cancer deaths worldwide are due to lung cancer.

The overall accuracy of EarlyCDT®—Lung is 92%.

You should always discuss the result with your clinician who can advise on the right follow-up care for you. A Moderate or High Level EarlyCDT®—Lung test result can be followed by CT scans at appropriate intervals to detect lung cancer earlier.

  1. The test results are reported as High Level, Moderate Level and No Significant Level of Autoantibodies Detected.

    A High or Moderate Level result means that you have an increased risk of having lung cancer. Your clinician will recommend the best follow up care, which may include CT imaging, based on your risk factors, symptoms, and radiological findings.

    A No Significant Level of Autoantibodies Detected test result means that none of the autoantibodies were found above the cut-off values. This result simply indicates that you are at lower risk of having lung cancer than if you had a Moderate or High Level result. It does not rule out the possibility that you may have lung cancer now, or develop it in the future. Your clinician will determine your plan for follow-up and monitoring. If your clinician recommends continued monitoring (or “watchful waiting”), a No Significant Level of Autoantibodies Detected result should help you feel less anxious about your clinician’s plans for follow-up.

Lung cancer is generally detected late, and therefore the 5-year survival rate is less than 20% in most countries worldwide. Early detection may be your best chance for surviving lung cancer. Studies have shown that if lung cancer is diagnosed in its early stage, the 5-year survival rate triples to 56%. EarlyCDT®—Lung can help your clinician detect lung cancer early, 4 and early detection of lung cancer has been shown to save lives.