BIOAXXESS offers Analysis & Interpretation of M30 and M65 ELISA Biomarker Data

In collaboration with
CANDOR Bioscience BIOAXXESS Consulting offers Analysis & Interpretation of clinical specimen Measurements with M30 Apoptosense® and M65® ELISA for medical research purposes. Both ELISA measure soluble forms of Keratin-18 as epithelial cell death biomarkers using human blood samples for oncology or hepatology.

Why is CANDOR Bioscience your partner of choice?

CANDOR Bioscience has been working in the field of biomarker assay development for many years. CANDOR offers great expertise in biomarker measurements through our highly experienced laboratory staff. In addition clients also benefit from our in-depth knowledge to handle “interference-rich” blood samples (e. g. due to matrix effects or interferences -HAMA/RF). This experience comes from many successful development projects involving customized biomarker immunoassays for CANDOR Bioscience’s pharmaceutical and biotech clients that use CANDOR’s proprietary blocking and anti-interference assay buffers (e.g. LowCross®-Buffer).


Who can make use of this service?

CANDOR offers this service to all clinical research groups who wish to evaluate PEVIVA's assays using blood (serum or plasma) samples from a specific patient cohort as part of a scientific (pilot) study. Scientific research as well as drug development processes can be supported through these biomarkers.

Which quality regulations apply?

CANDOR Bioscience is certified for DIN EN ISO 9001:2008. Our laboratory is run under well-controlled conditions and our staff is experienced in measurements of biomarkers in human specimen in general and of M30 and M65 in particular the latter have been established in our laboratory since 2007. CANDOR’s laboratory based in Germany, Wangen is not part of the official monitoring programme for Test Facilities or Test Sites under Good Laboratory Practise, (cGLP laboratory).

What can be measured by M30 and M65?

The desired endpoint of many drug treatments is tumour cell death. Thus serological biomarkers of apoptosis and necrosis are of particular interest. Apoptosis and necrosis of epithelial (most solid) tumours can be measured by M30 and M65 as shown by clinical studies.

Why should I use a serological marker instead of tumour biopsy material?

The availability of tumour biopsies pre- and serially post-drug treatment is very often unpredictable, particularly in an early clinical trial context. Considerable effort has been placed by many research groups on investigating the usability of potential pharmacodynamic biomarkers in readily available clinical samples such as serum. M30 and M65 can be measured in human serum, which is relatively easy to obtain. Many novel (e.g. biological or immunotherapeutic) may not lead to a significant tumour shrinkage according to RECIST (Response Evaluation Criteria drugs in Solid Tumours), but provide the clinical benefit of stable disease for patients.

What is the biological mechanism?

The CE-marked in vitro diagnostic assays M30 Apoptosense® ELISA and M65® ELISA, developed and manufactured by PEVIVA, AB, (now VLVbio) Sweden, detect caspase-cleaved (apoptotic) and full length K18 (apoptosis plus necrosis) are proposed as qualified serological biomarkers of epithelial cell death. Baseline M30 (corresponding to apoptotic, caspase-cleaved K18 (ccK18/K18F) and especially M65 (as a measure of total cell death that measures intact and K18 fragment: apoptosis plus necrosis) levels appear to be higher in patients with epithelial cancers (examples include pancreatic, prostate, lung, and breast carcinomas).

Have these M30 and M65 biomarkers been validated?

Several independently conducted clinical studies - e.g. at the Paterson Institute for Cancer Research in Manchester and the Karolinska Cancer Centre in Stockholm - demonstrate these K18 biomarker assays are “fit for purpose” showing a great potential as pharmacodynamic and efficacy biomarkers in clinical trials.

Are these biomarker assays already used in clinical trials?

The gradual increase in M30 post treatment suggests an apoptotic response to therapy. High pre-treatment levels of circulating full length K18 as detected by M65 ELISA may be explained by tumour proliferation and associated necrosis. Serological biomarkers of cell death are now being integrated into both academic and pharmaceutical led trials to accelerate future drug development.

How can I order this service?

Please give us a call on +44 (0) 1684 851 270 or email us at We like to discuss your needs and give you a competitively priced quotation based on your specific requirements. Any additional aspects such as specimen collection, storage and transportation to CANDOR Bioscience will then be discussed directly with our laboratory manager.

Is there additional information available?

For further details on the
M30 Apoptosense® and M65® ELISA and their application fields, please visit their product pages.