Advances in At-Home Cancer Testing

Cancer is a leading cause of death worldwide.¹ In 2020, there were an estimated 19.3 million new cancer cases and nearly 10 million cancer deaths.¹ Early detection of cancer means more treatment options, less extensive treatment and a higher chance of survival.^2,3 IVD technologies can help with early detection by bringing rapid point-of-care (PoC) and at-home testing directly to potential patients.³

In recent years, there’s been an increase in hospital-bedside cancer tests, which can be done quickly and provide rapid results.³ The next step is to make point-of-care (PoC) and at-home sampling and testing more accessible, so that more patients can receive timeous test results.³

Cancer Test Kits for Home Use

At-home cancer test kits require the patient to collect a sample for testing, such as urine, saliva or stool. The kit includes instructions and collection materials so they can collect the sample in the privacy of their home and then submit it for testing.⁴

The tests can determine the presence of cancer or, in some cases, show the patient’s likelihood of developing a certain type of cancer. This can help to detect cancer in its more easily treatable stages, sometimes even before symptoms appear.⁴

There are three types of at-home tests available:⁴

• Self-test: The patient performs the entire process of collecting a sample and interpreting the results (e.g. a home pregnancy test or COVID-19 test from a pharmacy). Most of these tests show results in under an hour.
• Self-collection test: The patient collects a sample and sends it to the laboratory to be analyzed. The results are sent to them electronically.
• Home-ordered test: The patient orders a test online or over the phone, but the sample collection and analysis are done in a laboratory.

These are a few ways patients are currently able to screen for cancer at home, using self-collection tests. The patient gets the test kit from their doctor or orders it online, collects the sample at home, mails it to the doctor’s office or a laboratory and receives the results electronically.⁴  Some of these currently available self-collection tests are explained below.

Guaiac fecal occult blood test (gFOBT) for colon/colorectal cancer
This test screens for colon/colorectal cancer by looking for traces of a blood component (known as heme) in a stool sample.⁵

Fecal immunohistochemical test (FIT) for colon/colorectal cancer
The FIT test also screens for colorectal cancer by detecting traces of blood in a stool sample, but it has a higher specificity for colon cancer than gFOBT⁵ and can also help to determine other causes of gastrointestinal bleeding.⁴

Genetic test for breast and ovarian cancer
This saliva test checks for 19 genes, including BRCA1 and BRCA2 which are known to increase the risk of developing breast cancer or ovarian cancer. It can help with cancer prevention as well as detection.⁵

DNA test for human papillomavirus
Human papillomavirus (HPV) is a sexually transmitted infection that can cause multiple types of cancer, including cervical cancer.⁶ It’s thought to be responsible for 90% of cervical and anal cancers.⁶ A self-collection test for HPV is available, where the patient sends a urine sample or vaginal swab to a laboratory to be tested for 14 high-risk HPV types.⁷ Testing is done using a nucleic acid amplification testing (NAAT) method.⁷

Point-of-Care Testing for Cancer

A PoC test is done close to the site of patient care or where care is being provided. PoC testing provides rapid results, so treatment can be started much sooner than when test samples are sent off to a laboratory for analysis.⁸

As of 2015, several PoC cancer tests have been commercially available, including tests for prostate, bladder, colorectal, cervical, liver, breast and lung cancer, as well as head or neck cancer caused by HPV. Additional promising testing prototypes have been developed since then.⁹

Advances in PoC-testing technology will help to make at-home testing more accessible and more common,³ but there are important criteria which should be taken into account when selecting or recommending these tests for patients.¹⁰

A suitable PoC diagnostic device should be:¹⁰

• Fast
• Cost-effective
• Highly sensitive for detection of early-stage cancer
• Highly specific to prevent misdiagnosis
• Simple enough for self-use by the patient, as well as by a GP or nurse
• Able to work without excessive processing of samples

Antibody-based testing is a popular method for PoC testing, but lectin*-based and aptamer^†-based assays are gradually becoming more common, due to their high levels of sensitivity and specificity.¹⁰

*Proteins that are not antibodies but which bind to carbohydrate-containing receptors^10b

^†A short segment of DNA, RNA or peptide that binds to a specific molecular target^10c

Multi-Cancer Early Detection Tests

Multi-cancer early detection (MCED) tests can detect multiple cancers in a single blood sample. As well as detecting the presence of cancer, they may also show which organ the cancer started in.¹¹

A clinical trial by the NHS is underway to evaluate the performance of a promising new MCED test called GalLeri^TM, which could be revolutionary as it’s designed to detect over 50 types of cancer. More than 47 of these cancers don’t currently have recommended screening methods in the UK.¹²

Mass screening is certainly a space to watch – this exciting study is just one of many developments we’re seeing in the field of cancer testing.

Medix Biochemica’s Contribution to Cancer Testing

Medix Biochemica produces antigens, antibodies, polymerases, and biospecimens for use in in vitro diagnostic (IVD) cancer testing, including at-home testing. We’re a full-solutions provider with an extensive portfolio of raw materials for IVD tests.³

For companies developing cancer tests, sample variation is a challenge. Even when a test works in the same way every time, samples from different patients may behave differently. Medix Biochemica’s attention to quality, however, means customers can rest assured that every batch of test ingredients will perform in the same way, taking as much of the guesswork as possible out of IVD cancer testing.³

Each of our products undergoes a rigorous quality control process, so we can provide you with consistently high-performing materials for IVD testing. If you’re developing an assay to test for cancer, partnering with us gives you access to a wide portfolio of excellent-quality materials.

References:

1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660.
2. Early detection = better outcomes. Prevent Cancer Foundation. Accessed October 10, 2023. https://www.preventcancer.org/early-cancer-detection-better-outcomes/.
3. Expert opinion. Interview with Anthony Austin, Global Marketing Manager at Medix Biochemica. September 29, 2023. 
4. 4 at-home cancer test kits. Accessed October 12, 2023. https://www.medicalnewstoday.com/articles/cancer-test-kits.
5. 6 at-home cancer screening tests. Healthgrades. Accessed October 12, 2023. https://www.healthgrades.com/right-care/cancer/6-at-home-cancer-screening-tests.
6. Basic information about HPV and cancer. CDC. Accessed October 12, 2023. https://www.cdc.gov/cancer/hpv/basic_info/index.htm.

6b. Cancer. World Health Organization. Accessed October 16, 2023. https://www.who.int/news-room/fact-sheets/detail/cancer.

7. iDNA^®. I do need answers^®. Accessed October 12, 2023. https://idna.com/products/hpv.
8. Larkins MC, Thombare A. Point-of-care testing. StatPearls Publishing; 2023. Accessed October 12, 2023. http://www.ncbi.nlm.nih.gov/books/NBK592387/.
9. Rodrigues M, Andrade I, Cruz R. Current point-of-care testing in cancer and future perspectives: a systematic review. Eur. J. Public Health, 2020(30):2. https://doi.org/10.1093/eurpub/ckaa040.033.
10. Hayes B, Murphy C, Crawley A, et al. Developments in point-of-care diagnostic technology for cancer detection. Diagnostics (Basel). 2018;8(2):39. doi:10.3390/diagnostics8020039.

10b. Definition of lectin. Merriam-Webster Dictionary. Accessed October 16, 2023. https://www.merriam-webster.com/dictionary/lectin.

10c. Medical definition of aptamer. Merriam-Webster Dictionary. Accessed October 16, 2023. https://www.merriam-webster.com/medical/aptamer.

11. Multi-cancer early detection tests. American  Cancer Society. Accessed October 12, 2023. https://www.cancer.org/cancer/screening/multi-cancer-early-detection-tests.html.
12. Symplify. Oxford Cancer. Accessed October 12, 2023. https://www.cancer.ox.ac.uk/research/projects/symplify.