Tuesday 3 September 2024 – AMLo Biosciences Ltd (Newcastle upon Tyne, UK) announce the successful receipt of the UKCA mark for AMBLor. AMBLor is a groundbreaking histopathological biomarker test for the personal identification of early-stage melanomas at low risk of progression, post staging diagnosis. This is the first in vitro diagnostic (IVD) of its kind that can reliably stratify non-ulcerated AJCC stage I-II melanomas that are unlikely to metastasise, potentially segmenting a group of patients that could be spared further diagnostic procedures and lengthy follow-up schedules. The UKCA label allows AMBLor to be marketed in Great Britain, meaning the test is now available to healthcare professionals. A recent Freedom of Information Act (FOI) request from the Liberal Democrats shows a 25% increase in patients on NHS waiting lists for skin cancer treatment and around 3,500 patients wait longer than the 62-day standard to start treatment, with some left waiting almost a year1. Nationwide use of AMBLor could help reduce waiting lists by identifying people whose melanomas are low risk and needing fewer appointments, thereby enabling more time slots to be available for other patients. Using the patients’ original skin biopsy, AMBLor identifies the presence of two prognostic proteins, AMBRA1 and loricrin, in the skin overlying the tumour. Absence of both these biomarkers in melanoma is associated with tumours at risk of metastasis or spread. The presence of one or both biomarkers is associated with a low risk of progression. Recently published validation data for AMBLor demonstrated a negative predictive value of 96.5%2, demonstrating the high accuracy with which the test can identify low-risk tumours. Around 20% of early stage I or II melanomas progress to metastatic disease, and the majority of deaths from melanoma occur in this early-stage group. With no accurate predictor of low-risk melanoma recurrence, all patients have had to follow the same disease management guidance3. This can involve sentinel lymph node biopsy, other imaging tests and up to 5-years of follow-up. Sentinel lymph node biopsy has a significant complication rate and recent meta-analysis has shown it to be less accurate in older people4,5. Patients can experience high levels of anxiety that can affect many aspects of daily life. Dr Marie Labus, CEO, AMLo Biosciences, commented, “We are excited that AMBLor has now received its UKCA mark and is available to the NHS and private hospitals. Adding this simple, effective, low-cost biomarker assay to the existing early-stage melanoma diagnostic tests can provide accurate prognostic information relating to tumour progression. We believe that it can enable clinicians to provide a more personalised approach to disease management, which may include consideration of the need for sentinel lymph node biopsy, also potentially easing patient anxiety at a difficult time.” Melanoma experts reported that having better prognostic information for earlystage melanoma could help reduce the burden of procedures and appointments on both patients and the stretched healthcare resources, plus it could assist in offering tailored treatment options and follow-up6. Mr Aidan Rose, FRCS (Plast), Consultant Plastic Surgeon, Newcastle upon Tyne Hospitals NHS Foundation Trust, added, “AMBLor receiving a UKCA mark is really great news. Now that it is available for use, we are very hopeful that it can be used to aid clinical decision making and help reduce the significant strains that many services are currently experiencing.” AMLo Biosciences offer an AMBLor e-learning package for pathologists. Please contact the company for access – details below. To order the AMBLor kit in the UK or request training details please contact: [email protected] or telephone 0191 580 7180. For general information: www.amlo-biosciences.com AMBLor® prognostic melanoma biomarker successfully receives UKCA mark Both companies believe this partnership will transform global Alzheimer’s disease diagnosis for patients with cognitive concerns or at high risk of future AD or ADrelated dementias. Healthcare Sector Eager for Easy-to-Access, Less Invasive Tests C2N previously announced in 2020 that the PrecivityAD® blood test achieved the CE Mark from the European Union (EU) and also has In Vitro Diagnostic Regulation legacy device status under Regulation (EU) 2017/746, which allows for commercial availability in the EU as an in vitro diagnostic to aid in the evaluation of patients with mild cognitive impairment or dementia. In addition, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency approved the PrecivityAD blood test as an in-vitro diagnostic to aid in the diagnosis of Alzheimer’s disease. C2N CEO, Dr. Joel Braunstein says, “The sobering impact of Alzheimer’s disease reaches beyond any one country’s borders and that’s why it’s vital we respond to the global interest in our Precivity blood tests. We believe this collaboration allows for the acceleration of equitable access to the highest quality blood biomarkers that can aid in the diagnosis of Alzheimer’s disease. To date, we’ve secured other international arrangements and now, we’re very proud to enter this multifaceted strategic affiliation with Unilabs, an organization that places a premium on quality in testing and in personalized diagnostics for Alzheimer’s disease.” The PrecivityAD2™ and PrecivityAD blood tests use highly sensitive and specialized laboratory technologies to identify and measure certain proteins that are found in the blood and that are known to be associated with the presence of brain amyloid plaques, one of the brain pathology findings of Alzheimer’s disease. The main test result is a clinically validated score that determines a patient’s likelihood category for the presence of brain amyloid plaques. Like other tests that evaluate for brain amyloid pathology in clinical patients, such as amyloid PET scan or cerebrospinal fluid (CSF) testing, the Precivity blood tests can be used by healthcare providers to interpret the test results, along with other medical information. The tests are intended for use in patients 55 years and older with signs or symptoms of mild cognitive impairment or dementia. These tests are only available for order by qualified healthcare providers. C2N and Unilabs expect the Precivity portfolio of blood tests will become available to Unilabs customers over the coming months, depending on geographic region. To inquire further about timelines for a specific country please email [email protected] or [email protected].
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