Point-of-Care Color Testing kit (POCT) for CA125 and Biologic Drugs

The primary objective of the project was to develop a simple Point-Of-Care Test (POCT) kit giving instant results for selected serum tumour markers. There has been a collaboration between GIAMAG Technologies AS (GIAMAG) and the Central Laboratory at Oslo University Hospital, Radiumhospitalet (OUHR). GIAMAG has developed patented magnets specifically designed for magnetic nanoparticle separation from small volumes. The Antibody Core Facility at OUHR has had the capacity to produce antibodies both for this research project, and mass production for possible later commercialization. The objectives of the project were to develop novel POCT kits for selected biomarkers, where such a test could reduce or remove the current delay between the test is ordered and the result is received, helping clinicians provide the right treatment faster. The test aimed at combining nanoparticle magnetic separation using the patented GIAMAG magnet technology, allowing instant visual detection of biomarkers. To have a proof of principle test case, we chose to use the serum concentration of CA125, a tumor marker for ovarian cancer. This is always measured when a pelvic tumor is found during a clinical or radiological examination, most often performed by a gynecologist. The result of the test is used in a risk-of-malignancy algorithm, which decides whether the patient should be referred to a hospital with specialists in gynecologic oncology or not. Currently, most patients and gynecologists must wait for several days for the result to come back from medical laboratories offering the test, unless they are already at a major hospital. In addition to delaying referral, this leads to anxiety for patients and extra work for the gynecologist. If a POCT could provide a result when the patient is at the gynecologist, the consultation and referral could be completed in one session. Avoiding this delay could reduce costs, patient anxiety and possibly improve treatment outcome. One crucial activity in the project was to find a reliable list of suppliers for monodisperse magnetic nanoparticles (MNP) and nonmagnetic nanoparticles (NNP) for the POCT unit. The nanoparticles (NP) must be tailor-made to enable attachment of antibodies which can specifically bind to antigens in biomarkers from various types of cancers. One important factor was to find submicron MNPs that did not aggregate. GIAMAG managed to find such particles with its expertise and earlier work on magnetic- and nonmagnetic colloids. The particles were also tested after functionalization by OUHR to ensure they did not aggregate. Another important activity was the development, design, and simulations of optimised GIAMAG separation magnets based on GIAMAGs patented technology for the POCT setup. Two different magnet realizations were finally obtained providing qualitative as well as quantitative determination of the biomarkers. The next important step was the testing of the mixture of NPs and antibodies and the analysis of the content. This was achieved by in house facilities and expertise at OUHR. Another crucial activity was the testing the mixture of NP and CA-125 biomarker and analyses of the content, also achieved with a high degree of reproducibility at the in-house facilities and the expertise at OUHR. We have thus been able to design and to have a protocol for a prototype of a POCT kit. It is the ambition to secure a patent on the POCT kit and attempt to commercialize the planned new technology in Norway and abroad. This will require the attraction of investors in the life science field. Another added value strategy of the POCT project was to make contacts with life science groups in Norway and abroad and offer these groups surplus GIAMAG magnets for free or cheaply. The condition was that these groups should report back to us about the efficiency of the magnets for magnetic particle separation and related results as well as refer to the use of GIAMAG magnets in publications.

Two areas could make a significant impact. 1. CA125 The serum concentration of CA125, a tumor marker for ovarian cancer, is always measured when a pelvic tumor is found during a clinical or radiological examination, most often performed by a gynecologist. A POCT test could provide a result when the patient is at the gynecologist, the consultation and referral could be completed in one session. Avoiding this delay could reduce costs, patient anxiety and possibly improve treatment outcome. 2. Biologic Drugs Measuring drug and anti-drug antibody concentrations in patients treated with antibody-based biologic drugs. A simple and reliable POCT has been requested by leading clinicians using these drugs, so they can avoid the 8-week delay and adjust drug dose immediately

The project is a collaboration between Giamag Technologies A/S (Company) and the Central Laboratory OUH-Radiumhospitalet (R&D partner). The project will develop a point-of-care test giving instant results for selected serum tumour markers and antibody-based biologic drugs, which currently must be sent to medical laboratory for testing. The technology is based on immunomagnetic nanoparticles separated from a solution. Giamag Technologies A/S has developed magnets specifically designed for this type of nanoparticle separation from small volumes, which will be a key enabling factor in the project. The Antibody Core Facility at OUH has capacity to produce antibodies both for the research project, and mass production for commercialization. The technology combines existing technologies in an innovative way,the technology is low-cost and simple compared to existing technologies in this field.