Cancer Screening Programmes

Colorectal Cancer Screening

Colorectal cancer (CRC) is preventable if caught early but it often has no symptoms early on. Colorectal cancer screening is vital as it can help detect cancer in its earliest stages, or even before it develops. Up to 90% of cases can be successfully cured if caught early with a primary health care-based CRC screening programme.

We can offer a combination of a FIT and Faecal Calprotectin Test, with one dry fluorescence analyser machine that both tests can be performed using. Experimental design analysed both FIT testing as well as faecal calprotectin and then determined the sensitivity, specificity and accuracy for each test and for the combination of tests. In total 658 patients were assessed – of which 286 were in the colorectal cancer arm and 372 in the adenomatous polyp arm.

Results are shown in the following table;

Detection indicator	Experimental Group (polyp / adenoma)			Experimental Group (colorectal cancer)
Detection indicator	Positive	Negative	Sensitivity	Positive	Negative	Sensitivity
Faecal calprotectin	314	58	84.4%	236	52	81.9%
FIT	252	120	67.7%	336	52	86.6%
Combined	342	30	91.9%	262	24	91.6%

As can be seen in this study, FIT testing alone was highly sensitive at detecting those patients with an established colorectal cancer. It out-performed faecal calprotectin but its sensitivity was increased by the addition of this test. In contrast, faecal calprotectin was more accurate for diagnosing pre-cancerous conditions but again, the addition of FIT testing increased the accuracy, even for pre-malignant processes.

Lung Cancer Screening

At present there are few countries that offer screening for lung cancer. China, the USA and Italy offer screening while in Holland there is the potential for screening in certain circumstances. In June 2023 the UK announced a new targeted lung cancer screening programme.

All countries screen using low-dose computed tomography (LDCT) and invite broadly the same specific at-risk population. Patients who are negative are generally invited back every two years until they pass the upper age limit.

USA: anyone with at least a 20 pack year smoking history (one pack year is smoking one pack per day for one year);currently smoke or have quit within the last 15 years; are between 50 and 80 years old.
China: anyone with at least a 20 pack year smoking history; currently smoke or have quit in the last five years; are between 50 and 74 years old.
UK: uses patient’s GP records for those aged 55 to 74 to identify current or former smokers and identify those who are high risk.
Italy: anyone aged between 55-75 who have had an average consumption of 20 cigarettes per day for 30 years; currently smoke or have quit in the last 15 years.

The NLST US low dose screening programme demonstrated a 20% reduction in mortality from lung cancer with 6.5 year follow up comparing LDCT to chest X-ray. The NELSON European trial published in 2020 (NEJM), looking at screening with LDCT demonstrated a relative risk of death from lung cancer at ten years of 0.76 (95% CI 0.61-0.94 p=0.01). The Netherlands will consider screening programmes based on the NELSON trial.

In the UK, 1.73 million plain x-rays were ordered in February 2018. For chest x-rays, 27% are requested from primary health care services, only 25% were reported on the same day as the test was ordered and the median time taken for a report was 2 days. For CT imaging only 33% are reported on the same day as the request. It is clear from this data that:

1. Screening will increase the workload of a radiologist reporting LDCT considerably
2. The number of chest x-rays already leads to a significant reporting burden
3. The number of chest x-rays leads to a significant number of CT requests
4. The burden of plain x-ray reporting alongside the reporting of an increase in CT images leads to delays in cancer diagnoses.

AI technology can be used to improve imaging statistics and potentially reduce waiting times or even necessity for CT imaging. AI technology can run 24 hours per day without emotional overlay or tiredness and its accuracy only improves with time. It has now been tested in the real world in direct comparison with radiology performance. AI technology, by excluding the need for CT and reducing the workload for reporting, has the potential to speed up reporting “normal” to under 30 seconds and prevent CT imaging in up to 75% of cases.

Our AI partner has published their real world data in independent peer-reviewed medical journals. They validated their detection of abnormalities in 3887 x-rays in four NHS Trusts. The auto-report of normal had an error rate of just 0.33% compared to radiologists – 13.5%.

This technology demonstrated a 60% reduction in missed cancers and a 15% increase in sensitivity for nodules / masses. Our AI partner places an “expert” at every site allowing health care provision in deprived areas to be as equitable as that in affluent areas.

The number of radiologists available for reporting, the number of sites performing diagnostic imaging and the number of CT scanners within these sites does not change, without major cost implications. However, a screening programme utilising LDCT as its primary diagnostic modality, will require increases in all of these parameters.

Our option for lung cancer screening allows for a programme to be deployed without any infrastructure changes. We would utilise AI technology to reduce the workload of scanners and radiologists to enable the programme to be implemented at low cost.

Cervical Cancer Screening

The popular method of cervical cancer screening is based on cytological analysis of endocervical swabs. However there is a precursor lesion of cervical cancer which leads to over 95% of cancers in this area. Human Papillomavirus (HPV) infection can be detected in vaginal swabs and will select out those individuals that require cytological assessment, more rigorous surveillance or colposcopy.

There are a number of HPV variants that exist and not all carry the same risk of cancer development. Low risk HPV variants are often associated with the presence of genital warts but do not lead to a significantly increased risk of cancer. High risk HPV variants are associated with over 90% of cervical cancers with the two highest risk HPV variants 16 and 18 causing 58% and 16% of cancers respectively. The other high risk HPV infections are HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Australia has now introduced self-screening vaginal swabs to detect HPV infection and identify the group of women that require further surveillance / treatment. Alongside this approach is vaccination against HPV to children of school age. The UK and the Netherlands have also introduced screening for HPV by self-testing as pilot projects. The UK’s pilot project took place in a select few north London boroughs where either women aged 25-64 years who were 15 months overdue for a check, or women who attended a GP appointment for another reason and were at least six months overdue a test, were offered a home test kit. The at-home test kit is an alternative to carrying out the swab via a healthcare professional (eliminating the degree of training required and invasiveness of the test compared to endocervical smear cytology), thus allowing more women to stay up to date with their routine cervical screening, and also reducing the total cost involved.

We can offer a combination of the swab sampling device, storage tubes and the PCR mix solution (this detects all 14 high risk HPV infections) while separately identifying HPV 16 and 18 in the same mix and experimental design. Once carried out, the swabs are stable for five days at 4^oC and for twelve months at -20^oC (normal freezer temperature).

The swab devices are CE marked and come complete with the tube containing preservation fluid. The PCR mix solution is also CE marked and is compatible with most thermal cyclers on the market. Therefore purchasing swabs and the PCR mix should give a turn key solution to HPV detection.

Once the swab is sent to the laboratory it is processed via Polymerase Chain Reaction (PCR) technology to detect the presence of HPV. The process of PCR is well established in most laboratories as it was used widely to detect the presence of SARS-CoV-2 infection during the pandemic. The infrastructure is already in place to carry out widespread screening of eligible women in most countries. In the event that this is not widely available, Kudu Spectrum can also provide PCR analysers.

Prostate Cancer Screening

Initiative is to screen eligible males with a simple to perform point of care test which gives results within ten minutes. This will serve the purpose of selecting those individuals for further investigation whether it be MRI prostate / prostatic biopsy, urology referral and/or confirmation of raised PSA using a quantitative method (e.g. laboratory assay). The current level of PSA used for further investigations is 4ng/ml. which is the level of detection used by the proposed semi-quantitative assay.

The strategy would be to semi-quantitatively test the number of 45-64 year old males in the population, selecting out those with a normal PSA and then quantitatively testing the remaining males with a positive lateral flow result using an immunofluorescence analyser. The population screen should be repeated yearly for all eligible males.

Test Name	Kit Size	Specimen	Time to result	Sensitivity	Specificity	Accuracy
Prostate Specific Antigen (PSA) Rapid Test Cassette	25	Whole Blood / Serum / Plasma	10 mins	100%	96.4%	98.0%

Liver Cancer Screening

An initiative could be set up to screen eligible citizens with a simple to perform point of care test which gives results within ten minutes. This will serve the purpose of selecting those individuals for further quantitative investigation.

The strategy would be to semi-quantitatively screen anyone with Cirrhosis or anyone who is either Hepatitis B or Hepatitis C positive. Those with an abnormal Alpha-Fetoprotein (AFP) level will be quantitatively tested using an immunofluorescence analyser. Eligible individuals should be invited back for repeat ultrasound and AFP test every six months.

Test Name	Kit Size	Specimen	Time to result	Sensitivity	Specificity	Accuracy
Alpha-Fetoprotein Rapid Test	25	Whole Blood / Serum / Plasma	10 mins	99.1%	98.9%	98.9%

General Cancer Screening

Progastrin is an intracellular protein that is the precursor of gastrin. When progastrin is maturated into gastrin, it is released from the cells. When gastrin is produced by the G cells of the stomach antrum, it plays its role to control acidic secretions during digestion. When progastrin is not maturated into gastrin, it is released from the cells as such and named hPG80. This only happens in tumor cells, whatever the tumor cell: progastrin becomes a circulating protein, hPG80, which can be detected in the blood of cancer patients.

Progastrin is not found in the blood of healthy people. The biomarker hPG80 is present in the tumour / bloodstream of cancer patients at all stages of tumour progression, from primary tumour to metastasis. The DxPG80 test is a practical and affordable professional laboratory use ELISA (Enzyme-Linked Immunosorbent Assay) for the detection of hPG80 (circulating human progastrin).

In addition to it being a general cancer screening tool the DxPG80 test can be used to monitor a patient’s response to chemotherapy, detect early cancer relapse, evaluate surgery efficiency and as surveillance after treatment. The laboratory testing can be performed at a distance, or a local licence can be offered to test within a territory.