CleoDX is changing the face of women’s healthcare

CleoDX Pre-Surgical Triage test

Cleo’s pre-surgical triage test is a new blood test to help doctors more accurately predict the chance that an adnexal mass might be an ovarian cancer, or whether it is a far more common benign growth.

By determining the risk of malignancy early, your doctor can identify the best course of treatment for you – and refer you quickly and efficiently to the right specialist for treatment.

Cleo’s Pre-Surgical triage test provides confidence for doctors and peace of mind for patients diagnosed with an adnexal mass


What is an Adnexal Mass?

An “adnexal mass” is a growth that occurs in the ovaries, fallopian tubes or surrounding tissues associated with the reproductive organs (the “adnexae”).

Most adnexal masses are benign (non-cancerous) and are not life threatening. They are very common, with up to 20% of women developing an adnexal mass in their lifetime.

If your doctor identifies an adnexal mass, the most important thing is to exclude any risk of the mass being or becoming cancerous. Whilst almost all adnexal masses are benign, your doctor will use a combination of ultrasound imaging, blood tests and other tools to help estimate the risk and identify what is required next.

An adnexal mass can also be malignant. Ovarian cancers are one kind of adnexal mass.

It is critical to identify the status of the adnexal mass as benign or malignant, to ensure the appropriate treatment is provided to you.

What is an Adnexal Mass?

  • An ADNEXAL MASS is an abnormal growth found in the ovaries, fallopian tubes or surrounding tissues (called the “adnexae”)

  • Most adnexal masses are benign (non-cancerous) in nature

  • Some adnexal masses will resolve with time; others may require surgery to remove

  • It is very important for your doctor to determine the risk that an adnexal mass might be malignant (cancerous)


Cleo’s Pre-Surgical triage test is a simple blood test to accurately predict risk and develop a rapid pathway for patient referral


What happens if I am diagnosed with
an Adnexal Mass?

When an adnexal mass is identified, your doctor will use your medical history, symptoms, and clinical tests to determine both the requirement for surgical consultation and any risk that a mass might be malignant.

Many adnexal masses can be identified as benign or malignant using ultrasound imaging.

Your doctor is also likely to request blood tests to help determine the malignancy risk. The results of both of these are used together with your medical history and symptoms to make a judgement about the next requirement in your care.

The purpose of these examinations are to exclude the risk of ovarian cancer as far as possible. It is important to remember that your doctor will always err on the side of caution.

Most adnexal masses are benign

Benign  (non-malignant) masses are growths that are not cancerous, and are generally not life-threatening. They are far more common than cancer.

Some adnexal masses will go away on their own. Some will require further monitoring to observe whether they resolve, grow or change.

Others however will require surgical removal. This might be because the mass is pressing on other organs and causing problems, or it might be to eliminate any risk of cancer – or both.

What if I need surgery?

Your doctor will make a judgement regarding the risk of malignancy, and refer you to an appropriate specialist. This might be a gynaecological specialist if the mass is benign, or a gynecological oncology specialist if there is any risk of malignancy.

Surgical removal is the only way to accurately diagnose whether a growth is benign or malignant

The current ovarian cancer blood test CA-125 is not accurate, and can mis-diagnose both cancers and benign disease. For this reason the nature of many masses (i.e. benign or malignant) cannot be accurately determined, and your doctor is likely to make a referral to a cancer specialist to ensure the risk is managed appropriately. It is important to remember that your doctor will always err on the side of caution.

If you are diagnosed with an Adnexal Mass :

  • Ovarian cancer occurs in the female reproductive organs, and can migrate to other areas in the abdomen

  • In their early stages ovarian cancers usually have no clear symptoms, and most diagnoses occur at an advanced stage.

  • Ovarian cancer is more common in women over 50, those with specific genetic mutations (like BRCA), or those with a family history of breast and ovarian cancer.

  • Treatment usually involves surgery and chemotherapy

  • There is currently no screening or early detection method for ovarian cancer.

Key Ovarian Cancer Facts

  • Ovarian cancer occurs in the female reproductive organs, and can migrate to other areas in the abdomen

  • In their early stages ovarian cancers usually have no clear symptoms, and most diagnoses occur at an advanced stage.

  • Ovarian cancer is more common in women over 50, those with specific genetic mutations (like BRCA), or those with a family history of breast and ovarian cancer.

  • Treatment usually involves surgery and chemotherapy

  • There is currently no screening or early detection method for ovarian cancer.

Cleo Diagnostics is challenging the status quo by making earlier detection of ovarian cancer a reality


Ovarian Cancer

Ovarian cancer is a general term used to describe a cancerous (malignant) growth (tumour) found in one or both ovaries. Ovarian cancers can appear as masses on the ovaries or fallopian tubes, and may quickly spread to other locations in the abdomen.

There are several different types of ovarian cancer, and the type of tumour will determine the treatment required and the long-term prognosis. The most commonly diagnosed form of ovarian cancer is called “Epithelial” which resemble cells from the ovarian surface, and accounts for ~90% of all cases.

Other main types include “Germ Cell” (~4%) that resemble cells that produce eggs; and “Stromal” (~6%) that resemble cells found in the supporting tissues of the ovary.

Treatment of ovarian cancer varies according to the type of cancer and extent of spread at diagnosis. Generally, both surgery and chemotherapy are required.

Ovarian cancer is a rare disease, with lifetime risk of ~1.1%.


What are the symptoms of Ovarian Cancer

Ovarian cancer symptoms are vague, and often difficult to identify. Whilst many of the symptoms below can be caused by other much less serious medical conditions, it is very important you see your GP if you experience any of them persistently. The earlier a cancer is found, the more successful treatment will be.

Commonly reported ovarian cancer symptoms:

  • Increased abdominal size or persistent abdominal bloating

  • Abdominal or pelvic pain

  • Feeling full after eating a small amount

  • Needing to urinate often or urgently

Less commonly reported symptoms:

  • Changes in bowel habits

  • Unexplained weight gain or loss

  • Excessive fatigue

  • Lower back pain

  • Indigestion or nausea

  • Bleeding after menopause or in-between periods

  • Pain / bleeding during or after intercourse

Causes and Risk Factors

The underlying causes of most ovarian cancers are still unknown. However, there are factors that can increase a woman’s risk of developing ovarian cancer.

Getting older is the biggest risk factor for developing ovarian cancer. Ovarian cancer can happen at any age, but it is usually in women who have been through menopause, with the average age of diagnosis being age 62.

Hereditary factors account for approximately 20% of ovarian cancers. Women who are carriers of mutations in the “breast cancer genes” BRCA 1 or BRCA 2 are at a higher risk of developing ovarian cancer. Similarly people with Lynch Syndrome, who carry mutations in DNA mismatch repair genes, also have an increased risk of ovarian cancers. A familial history (first or second degree relatives) of breast or ovarian cancer, in the absence of any known mutations, is also a risk factor.

Other factors associated with ovarian cancer risk include:

  • endometriosis

  • diabetes

  • having had breast cancer previously

  • use of hormone replacement therapy (HRT)

  • being overweight

  • smoking

  • not having had children (nulliparity)

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