QuantumA Matter of Life

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QUANTUM MEDICAL UPDATEwww.quantumdxs.comBringing Science to LIFEIssue 3

MS ISO 15189

The key points from the study are as follows:1. iM2PK is significantly more sensitive in the detection of CRC than FOBT. iM2PK had a test sensitivity of 97.5% vs FOBT

with a test sensitivity of 47.5%. Test specificity from both tests was equal at 100.0%. This means that as a screening tool for CRC, iM2PK is twice as sensitive as FOBT at detecting CRC with an equally low false positive rate.

2. iM2PK is significantly more sensitive in the detection of adenoma than FOBT. iM2PK had a test sensitivity of 69.2% vs FOBT with a test sensitivity of 19.2%. Test specificity from both tests was equal at 100.0%. Adenomas (adenomatous polyps) >5mm in size have potential of developing into CRC, with the risk of carcinogenesis increasing with size (Adenomas >20mm have a 50% chance of becoming malignant).

3. iM2PK has a significantly higher negative predictive value (NPV) in CRC detection than FOBT. iM2PK has a NPV of 83.3% vs FOBT with a NPV of 40.7%. The NPV of iM2PK is double that of FOBT which means that clinicians can inform patients of their results with greater confidence (lower false negatives).

Please find overleaf a how to guide on performing the M2PK Quick test.

References:

1. Faecal pyruvate kinase isoenzyme type M2 for colorectal cancer screening: a meta-analysis. Tonus et al. World J Gastroenterol. 2012 Aug 14;18(30):4004-11.

2. The Usefulness of a Novel Screening Kit for Colorectal Cancer Using theImmunochromatographic Fecal Tumor M2 Pyruvate Kinase Test. Kim et al. Gut Liver. 2014 Dec 5. doi: 10.5009/gnl13457. [Epub ahead of print]

Dear Colleague,Colorectal cancer (CRC) is the second most common cancer in Malaysian men and women – accounting for up to 12.3% of all reported cancers (National Cancer Registry Report 2007). Unfortunately, 91% of Malaysian CRC cases diagnosed are Dukes B, C and D (Stage II, III, IV) which means lower cure rates, higher patient mortality and poorer overall outcomes. The reason for this is not just poor patient awareness about CRC and its presentation, but also the lack of a sensitive and convenient screening test. The M2PK Quick test is a novel non-invasive screening test for colorectal cancer (CRC) and colorectal polyps. Pyruvate kinase isoenzyme type M2 (M2PK) is an enzyme expressed by polyps and CRC cells which can be detected in stool. The M2PK test comes in a self collection kit which allows immediate and convenient testing by the patient or doctor. Alternatively, we may perform the test on your behalf at any of our collection centres.We want to ensure that doctors are kept updated on the latest available data for our tests. This is important as new data/publications may highlight new issues with screening tests or broaden the uses of these tests in a clinical setting. A meta-analysis by Tonus et al published in the World Journal of Gastroenterology has already advocated the use of faecal M2PK as a routine test for CRC screening. The mean sensitivity of faecal M2PK in CRC detection was 81.1%, double that of FOBT at 36.9%. The test specificity of 95.2% also means a significantly lower rate of false positives. In this issue, we will update you on the results of the most recent M2PK study published by The Catholic University of Korea College of Medicine, South Korea. This is an important trial because the vast majority of previous studies and trials were carried out on European populations. Given the differences in CRC prevalence, patient ethnicity and composition, lifestyles and diet, the results of the South Korean study are more applicable to our local population. Going forward, we will see increasingly more local data on M2PK as trials are currently being carried out in hospitals in Malaysia and Singapore. The South Korea study compared immunochromatographic M2PK (M2PK Quick test) against M2PK ELISA testing and conventional Faecal Occult Blood Test (FOBT) in the detection of CRC and adenoma. All patients involved in the study underwent colonoscopy to confirm/exclude the diagnosis.

Produced by Dr. Tan Shih Yang, Medical Affairssytan@quantumdxs.com

Disclaimer of Medical LiabilityQuantum Diagnostics Sdn Bhd and the author are not responsible or liable for any advice, course of treatment, diagnosis or any other information, services or products that an individual obtains through this document. This document is not for use in medical emergencies and users should exercise their own clinical judgment in their practice.

How to Perform The M2PK Quick Test

The test kit comes complete with the M2PK Quick cassette, tube containing the extraction buffer (yellow tip) and a pipette for sample application.

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Ensure sample shaken well and there is no stool remaining on notches. Using the pipette provided, apply 4 drops of stool extract into the circular sample well on the cassette.

4Before using the extraction buffer, remove the yellow tip. Insert the white dosing tip with the patient’s stool sample into the extraction buffer.

Test Successful – POSITIVE ResultRecommend follow up with diagnostic confirmation – Refer patient for Colonoscopy.

Wait for exactly 5 minutes before reading cassette result. The C (Control) marking ensures confirms that the test has been successfully performed with an adequate stool sample.The T (Test) marking indicates the test result – a visible marking indicates a positive result, no marking indicates a negative result.

Patient tube with dosing tip (white tip) – Ensure all 4 notches covered with stool

Test Successful – NEGATIVE ResultRecommend follow up repeat test in 12 months. If symptoms still suggestive of CRC consider referral for diagnostic confirmation.