Health
Banyan Biomarkers Announces Results of ALERT-TBI Study
By Dipo Olowookere
A pioneer in developing biomarkers for traumatic brain injury (TBI), Banyan Biomarkers, has announced publication of the results for the ALERT-TBI study, an international, multicentre clinical trial utilizing the Banyan Brain Trauma Indicator (Banyan BTI).
The Banyan BTI is a diagnostic blood test used to rule out the need for a head CT scan in patients 18 years of age and older with a suspected TBI. The results, published in The Lancet Neurology, support the clinical role of the biomarker test for ruling out the need for a head CT scan among emergency department TBI patients who would normally receive a head CT scan.
The ALERT-TBI study enrolled patients at 22 independent clinical sites in the United States and Europe and compared the Banyan BTI test’s results to head CT scans of patients presenting to emergency departments with suspected head injury. Analysis of 1,959 patients presenting with an initial Glasgow Coma Scale of 9-15 from the study showed that the Banyan BTI achieved high sensitivity (97.6%) and high negative predictive value (NPV) (99.6%) for ruling out the need for a head CT scan in these patients.
Banyan BTI identifies two brain-specific protein biomarkers Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) that are detected in the blood soon after a brain injury. In February, the U.S. Food and Drug Administration (FDA) granted marketing authorization to Banyan Biomarkers for the commercialization of Banyan BTI to aid in the evaluation of patients with a suspected mild TBI or concussion. There is another biomarker, S100B, that has limited adoption in Europe but is not approved for use in the United States.
“This blood test meets an important public health need to reduce the number of unnecessary CT scans particularly among those with mild TBI—also called concussion—who make up over 85% of all TBIs. In emergency medicine, CT scans are often used in evaluating these patients, even though fewer than 10 percent of scans reveal an abnormality,” said Jeff Bazarian, MD, MPH, principal investigator of the study, one of the lead authors on the publication, and professor of Emergency Medicine and Neurology at The University of Rochester School of Medicine. “This extensive clinical study shows that these two blood-based brain biomarkers can predict the absence of intracranial injury and reduce unnecessary head CT scanning, thereby reducing radiation exposure and healthcare costs while improving patient care and emergency department efficiency.”
“This large, prospective, multicenter trial validated the ability of the Banyan BTI to rule out the need for head CT scan in patients with a suspected TBI within 12 hours after injury. The FDA reviewed and authorized for marketing the test in fewer than six months as part of its Breakthrough Devices Program,” said Henry L. Nordhoff, Chairman and CEO of Banyan Biomarkers. “We are working closely with our commercial partners to make the test available in hospitals and emergency departments.”
The company is also engaged in additional TBI studies to evaluate the biomarkers in sports concussions, in adolescents, and for monitoring recovery from brain injury.
By Adedapo Adesanya
The National Health Insurance Authority (NHIA) says the number of Nigerians enrolled in health insurance has risen to more than 22 million.
The Director-General of NHIA, Mr Kelechi Ohiri, said this resulted from the implementation of the mandatory health insurance, which has gained momentum nationwide.
He said this on Wednesday at the Annual General Meeting of the Nigerian Association of Insurance and Pension Editors (NAIPE) in Lagos.
Mr Ohiri said enrolment had increased to 22.03 million, representing a 35 per cent year-on-year growth, attributing this to stronger collaboration with state social health insurance agencies, ministries, departments and agencies, organised labour, employers, the private sector, and the gradual implementation of the mandatory health insurance provisions of the NHIA Act.
He said that the country had moved beyond policy formulation to delivering measurable improvements in healthcare access, service quality and consumer protection in line with the federal government’s health sector reform agenda.
According to him, Nigeria already has the necessary policies and legislation to achieve Universal Health Coverage, positing that the key challenge was effective implementation.
“The decisive variable is now implementation- consistent, rigorous and accountable execution that converts political commitment into healthcare access for real Nigerians,” he said.
Mr Ohiri said that the transition from the former National Health Insurance Scheme to the NHIA had strengthened regulation, consumer protection, accountability and strategic purchasing, while providing the legal and operational framework for achieving Universal Health Coverage.
He added that improving the experience of enrollees remained central to the Authority’s reform agenda.
According to him, NHIA has strengthened its complaints management system, introduced faster resolution timelines, and intensified compliance monitoring of Health Maintenance Organisations (HMOs) and healthcare providers.
He further added that NHIA had sanctioned facilities that failed to meet the required standards, adding that his organisation had resolved 3,878 complaints, representing an 87 per cent resolution rate, while 95 per cent of the cases were concluded within prescribed timelines.
Mr Ohiri noted that more than N14.2 million had been refunded to enrollees, while non-compliant healthcare facilities had been sanctioned.
He said NHIA had also introduced service standards, including a one-hour treatment commencement target for enrollees requiring urgent care, to improve access to timely and quality healthcare services.
The NHIA boss further disclosed that capitation payments to healthcare providers had been increased by 93 per cent.
He said fee-for-service reimbursements rose by 378 per cent to enable providers to invest more in personnel, equipment and infrastructure.
According to him, 7,592 healthcare facilities have been assessed under the SafeCare quality framework as part of efforts to institutionalise continuous quality improvement across the country.
Mr Ohiri also highlighted interventions targeted at vulnerable groups, including support for more than 48,500 pregnant women, expanded maternal and newborn healthcare services, the Vulnerable Group Fund, and improved access to healthcare for pensioners and retirees.
He said Universal Health Coverage could only be achieved if every Nigerian, regardless of income or location, had access to quality healthcare services.
By Modupe Gbadeyanka
The new one-hour authorisation response time ultimatum policy introduced by the National Health Insurance Authority (NHIA) has received the full backing of SUNU Health Nigeria Limited.
This policy was introduced by the agency to ensure enrollees get prompt approval codes to access care.
Healthcare service providers have been urged to report any Health Maintenance Organisation (HMO) that violates this initiative through an email, with the HMO in copy and a timestamp attached as evidence of the request. They may proceed to offer services to enrollees thereafter.
Speaking at the company’s second-quarter Providers’ Forum for the Lagos-Ogun region in Lagos recently, the chief executive of SUNU Health, Dr Moyosore Olomola, expressed optimism that this policy would improve healthcare delivery in the country, especially for enrollees, who crave quality service.
At the event themed Improving Quality and Access to Care Through Stronger Provider Network, and held at the Nigerian Institute of Medical Research (NIMR) in Yaba, Lagos, Mr Olomola reaffirmed the HMO’s commitment to operating within legal and operational frameworks to guarantee adequate care for enrollees.
“Access to care and quality of care remain key priorities in our healthcare systems. We know quite well that deliberate collaboration, strategic partnerships, and a shared commitment to excellence are required to achieve these priorities.
“A strong provider network is doubtless the backbone of any effective healthcare system. It ensures that our mutual enrollees receive the right care, at the right time, in the right place, and at the right price,” Mr Olomola, represented at the programme by the organisation’s Chief Operating Officer (COO), Dr Faith Nwachi, stated.
He further assured that SUNU Health would strictly adhere to the one-hour authorisation limit, stressing that this aligns seamlessly with one of the organisation’s core values—promptness and its corporate slogan, Humanity is the centre of our initiatives.
In a bid to further improve access and quality of care, SUNU Health also demonstrated its new operational software and Mobile app, aptly named SUNU Legacy.
Also speaking at the event, the NHIA Lagos State Coordinator (Ikeja), Dr Bethuel-Kasimu Abraham, noted that the forum’s expected outcome is to significantly reduce delays in accessing medical care.
Other key expectations include ensuring continuity of care, improving patient outcomes, and strengthening accountability among HMOs.
Addressing specific pain points faced by enrollees, the NHIA Ogun State Coordinator, Mr Dare Adefeso, acknowledged that the agency had received complaints regarding out-of-stock drugs and the discrimination of enrollees by certain providers.
He affirmed that the NHIA is actively addressing these issues, stressing that moving forward, every facility must ensure enrollees are properly catered to regardless of their status, provided they have an active health insurance plan.
Corroborating the long-standing legacy of SUNU Health, the Ogun State Director of the National Orientation Agency (NOA), Mrs Aishat Tiamiyu, shared that her agency is responsible for public information dissemination and has been enrolled with SUNU Health for over 25 years.
Commending the HMO’s stellar service over two decades, she called for the immediate enrollment of new NOA staff into the scheme.
The Providers’ Forum remains one of the strategic channels employed by SUNU Health to consistently engage healthcare providers, understand their operational challenges, introduce new software updates, and solidify partnerships aimed at fostering premium healthcare delivery across Nigeria.
By Aduragbemi Omiyale
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the recall of a sexual enhancement product known as WAP Sensual Enhancement Capsules.
In a statement on Monday, the Nigerian agency disclosed that the recall is due to “undeclared pharmaceutical ingredients” in the product, whose country of origin is unknown, but is marketed and distributed online in the US through eBay.
It was emphasised that the recall is being “voluntarily” made by the manufacturer, Best Supplements Best Prices Company.
The detection of the undeclared pharmaceutical ingredients was made by the US Food and Drug Administration (FDA).
Laboratory analysis by the US FDA revealed that the product contained undeclared sildenafil, tadalafil, and flibanserin, which were not mentioned on the product label. Such substances may include phosphodiesterase type-5 (PDE-5) inhibitors or related compounds commonly used for the treatment of erectile dysfunction, the statement by NAFDAC stated.
Sildenafil and tadalafil are ingredients in FDA-approved prescription drugs used to treat erectile dysfunction.
It was noted that these undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Flibanserin is the active ingredient in an FDA-approved prescription drug used to treat low sexual desire in women. Flibanserin can cause drowsiness, sedation, dangerously low blood pressure, and fainting, especially when combined with alcohol.
Consumers have been encouraged to report compromised products (medicines or medical devices) to the nearest NAFDAC office, call 0800-162-3322, or send an email to sf******@********ov.ng.
