Cambridge Nutranostics Has Developed A Point-Of-Care OCCL Test Prototype For Testing Blood Plasma Oxygen To Monitor Pregnancy Health

Cambridge, MA /PRNewswire/ - Cambridge Nutranostics Ltd (CNL, https://www.occltest.com) has begun to validate in clinic its first prototype of a test to assess and monitor plasma oxygen, the part of the total blood O2, which can cross the capillary wall and deliver this essential gas for tissue cell respiration. This test would require only one drop of capillary blood and provide results within a couple of minutes. There is no need for any special equipment or training to do the test and therefore it can be used in any clinic or at home.

The fact that most of the oxygen in tissue, due to the hydrophobic nature of the gas, is concentrated in cell lipid structures, was established over 60 years ago. In 1997 a group of medical researchers from Cambridge University and Papworth Hospital, UK, led by Dr Ivan Petyaev, published their discovery that extracellular lipids, lipoproteins, can be the main oxygen carrier in blood plasma (https://pubmed.ncbi.nlm.nih.gov/9505864/). This work was supported by the British Heart Association.

In the following years the role of the oxygen carrying capacity of lipoproteins, OCCL, their ability to deliver O2 to tissues, was evaluated in a number of physiological and pathological conditions. It was found that a decline in OCCL, a reduction of oxygen supply to tissues, might contribute to depression of their functions and development of tissue hypoxia. In subsequent interventional studies it was observed that an increase in OCCL resulted in an improvement of peripheral tissue oxygen saturation and associated metabolic and physiological parameters.

CNL has now successfully completed conversion of the established laboratory format OCCL test to its express dry chemistry based point-of-care diagnostic, which should be affordable and can be used not only by any health care practitioner but also by an untrained person at home.

The company's first marketing target for this test is pregnancy, from planning through all its stages. The OCCL point-of-care test would allow a health care practitioner or the person herself, to assess the level of plasma oxygen and detect its potential changes, which may not have any other clinical manifestations. Early diagnostics of these changes may trigger additional medical examination and allow measures to be taken to improve tissue oxygenation and support pregnancy health.

23 million miscarriages occur globally every year. A recent editorial from the Lancet describes the current attitude of the health-care system towards miscarriages as unavoidable and says that urging women to "just try again," must have a comprehensive overhaul and reforms (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00954-5/fulltext). Not all miscarriages but many can be prevented and avoided. However, early diagnostics and early intervention can save the lives of millions of unborn and longed for babies to be saved.

For example, in China when the Third-Child Policy with significant financial incentives is adopted, the prevalence of miscarriage remains high and is growing. This is a result of ongoing changes in society and women's lifestyle trends: the time of the first pregnancy is being delayed, the global obesity pandemic is spreading and there is an increase in alcohol, caffeine and medication use.

Whatever the cause of the development of miscarriage, deep hypoxic damage of the foetus leads to its necrosis and rejection. Partial hypoxia leads to a delay in foetal, then baby and then child development. The OCCL test does not determine the factor leading to the development of a miscarriage, but it can assess the level of plasma oxygen and its potential changes at any stage of pregnancy. The better the control of tissue oxygenation the better the support for pregnancy health.

After completing the OCCL point-of-care test validation and optimisation programme, CNL is planning to obtain its FDA marketing authorisation for commercialisation in the USA and CE mark in Europe. The company is expecting to launch this test by the end of 2022. Alexey Shulepov, the CEO of CNL, says: "The company is proud to develop this test for pregnant women, it is a great humanitarian mission to help to save thousands of new lives and improve the quality of life in every country."