A step closer to multi-cancer early diagnosis availability for patients in low- and middle-income countries

Please note that the full article was originally published in Health Management Journal Volume 23 – Issue 3

The scale of destruction wreaked on human life and happiness by cancer is a recurring topic of discussion and this destruction becomes even more tragic in cases where we know it could have been avoided. This is often the case in low and middle-income countries (LMICs) where 84% of the global population currently reside. In LMIC environments, basic treatments such as surgery and radiotherapy are available however they are most effective in early stages whereas long distances from rural areas to medical centres often result in late disease detection and diagnosis requiring targeted therapies or immune therapy which are less widely available.

A case from personal experience

The following case from personal experience of Dr Arthur Ajwang (Kisumu hospital Kenya) may serve as a typical example: Patient L.O.O., who was diagnosed with Stage 4 cancer of the oesophagus and needed to have a stent fitted to continue eating after a late diagnosis, could not hold back his tears telling me how he had spent almost 3,000,000 Ksh over the past 3-4 years in different private hospitals seeking diagnosis, treatment and cure for the fact that he could no longer eat solids, and because he had never had insurance cover, he had to use all his savings and sell his parcels of land to receive a very late diagnosis, and an oesophageal stent for swallowing, as he waited for his death.

Dr. Ajwang characterises the situation as follows: “Late diagnosis of cancer in the low- and middle-income countries, especially in Africa, contributes to 70-80% of annual cancer mortality. There is also the issue of misdiagnosis at many levels of the healthcare system, e.g. when vague symptoms mean that healthcare workers do not have a high index of suspicion and go on to perform multiple diagnostic tests looking for other diagnoses, which can take years, not to mention thousands of shillings and a toll on the patients and their relatives, before cancer is finally diagnosed in very late stages. Another handicap is that, despite several cancer screening techniques being available in clinical practice, the high cost of these methods, together with their need for specialised infrastructure and skilled technicians, limits their application”.

Evidence

These personal observations are underpinned by enormous statistical evidence. Cancer mortality after diagnosis in LMICs is much higher than in high-income countries. Mortality rates in sub-Saharan Africa now rank among the highest in the world and are largely attributable to late stage presentation. Our Patient Advocate Dr. Mao Mao and his team have developed a diagnostic method specifically for application in LMICs (please see Yi Luan, Guolin Zhang, Shiyong Li, Wei Wu, Xiaoqiang Liu, Dandan Zhu, Yumni Feng, Yixia Zhang, Chaihui Duan, Mao Mao. A panel of a selected number of protein tumour markers for effective and affordable multi cancer early detection by machine learning: a large scale and multicentre case-control study. eClinicalMedicine 2023;61: 102041).

Criteria for this diagnostic method

Their diagnostic method needs to meet the following basic criteria:

• high accuracy diagnosis based on one single blood sample
• capacity to detect multiple cancers
• contribution to early detection and diagnosis
• universal, standardised and automatic technical laboratory platform
• technical laboratory platform within 3 days postal delivery to maintain blood sample quality
• cost low enough for broad application in LMIC’s
• the use of multiple protein assay and machine learning to reduce false positives
• the need to assist in finding tissue of origin
• the need for upgradability to make future improvements in specificity, sensitivity and coverage of more cancer types

The result is a diagnostic using a panel of seven Protein Tumour Markers (PTMs) plus the age and sex of the person involved. The core of the diagnostic is an ML-enhanced algorithm called OncoSeek. Thanks to the ML algorithm, a very high specificity (probability of a negative result if the disease is not present) of 92.9% was obtained. This is desirable in any setting, but especially in LMICs because false positives cause the patient great anxiety and require extra cost for subsequent verification of the diagnosis by other means. The sensitivity (probability of a positive result if the disease is actually present) in the present version is 51.7% and, in cases where the test result is positive, OncoSeek also delivers a first indication of the Tissue Of Origin (TOO) with an accuracy of 66.8%.

It only requires a tube of blood

The OncoSeek test requires a simple tube of blood which can be drawn by a nurse or a midwife and then sent by mail for analysis in a central laboratory with standard lab equipment. The test relies on protein quantities rather than Whole Genome Sequencing which is more costly. The total cost of the test is the sum of the costs connected to taking the blood sample, mailing the sample to the central laboratory, operating standard lab equipment, processing the data and communicating the results, all of which are available and affordable for very many people in LMIC, showing that the diagnostic meets the design criteria and choices mentioned earlier.

The next step

The next step is for this method to be made more widely available to the medical community and to millions of patients in more than a hundred LMICs. In each country it starts with gaining acceptance, often by means of a trial, followed by the implementation of an efficient and reliable process and quality guarantees. All process steps need to be designed and contracted with great reliability and at the lowest possible cost. The Inspire2Live Foundation is working closely with SeekIn (the biotech company behind OncoSeek) to find potential investors and coordinate the project implementation and management.

Game-changing

The road ahead is still long, but let us take strength in the vision expressed by Doctor Ajwang and his patients, namely that “OncoSeek will be a game-changing and life-saving multi-cancer early detection test in Kenya and across Africa.”

Tielo Jongmans,
Patient Advocate Inspire2Live

The full article was originally published in Health Management Journal and created by:

• Arthur Ajwang | Medical Doctor | Kisumu Teaching and Referral Hospital | Tutorial Fellow | Uzima University School of Medicine | Kenya
• Shujia Hao | CFO and Co-Founder | SeekIn Inc | China
• Tielo Jongmans | Patient Advocate | Inspire2Live | Netherlands

You can also read the full article here >>