Nagpur, India: At the Haematocon 2024 conference in Nagpur, India, Hemex Health announced new product offerings for the Company’s Gazelle™ Diagnostic Device that will increase diagnostic accessibility for at-risk populations in challenging environments:
- A next generation Snap Cartridge, part of the Gazelle™ S-10B Hb Variant Test Multipack, will simplify sample preparation so that minimally trained health workers can perform the test for Hb Variants. Like the existing version of the Gazelle Hb Variant test, the S-10B provides interpretations for sickle cell disease (SCD) and beta thalassemia in the field.
- The new Gazelle™ Ferritin FIA Test will offer highly accurate measurement of ferritin levels for improved clinical diagnosis of iron deficiency anaemia (IDA) using whole blood or serum.
Physicians who provide care for patient populations with a high prevalence of SCD and IDA see great potential utility in these new Gazelle product offerings.
“With the ease of use provided by the Snap Cartridge, health workers can reach communities in a variety of venues — from schools to community events and local health durbars,” said Dr. Catherine Segbefia, Korle Bu Teaching Hospital, Accra, Ghana. “This increased access to testing is crucial for identifying genetic carriers, who have ‘sickle cell trait’, and those with haemoglobin disorders like sickle cell disease and beta thalassemia. It will ensure that people are able to receive timely care and health education.”
“Point-of-care testing for ferritin is a transformative tool in our ability to diagnose and manage iron deficiency anaemia, sickle cell disease, thalassemia, and other haematologic and oncologic conditions worldwide, especially in low- and middle-income countries where the burden of these diseases is profound," said Dr. Akshat Jain, renowned haematologist from Los Angeles, California and visiting faculty of SMS Medical College, Jaipur, Rajasthan.
New Gazelle™ Hb Variant Test Multipack with the Snap Cartridge Offers Improved Usability for the Hb Variant Test
The current Gazelle™ Hb Variant Test empowers frontline healthcare professionals to perform laboratory-quality testing of Hb Variants that can aid in the diagnosis of sickle cell disease (SCD) and beta thalassemia directly at the point of care. Hemex Health has made the test simpler and faster with the introduction of the next-generation Gazelle™ Snap Cartridge. This innovative cartridge design- informed by usability testing- allows for simplified sample preparation.
The Snap Cartridge eliminates the need for pipetting or additional supplies, making it easier to use by healthcare workers at all skill levels. Usability studies have shown that even minimally trained health workers can successfully perform the test, which significantly broadens the pool of potential operators in resource-limited areas.
The product release of the Gazelle™ Hb Variant Test Multipack with the Snap Cartridge is currently pending regulatory approval in India. For availability, please check www.hemexhealth.com.
With Gazelle™ Ferritin FIA Test Offering, Gazelle Now Aids in Identifying the Two Major Causes of Anaemia
Iron deficiency is the leading cause of anaemia, with most other cases of anaemia caused by SCD and Beta Thalassemia (which can be tested by the Gazelle™ Hb Variant test). When iron deficiency anaemia- which occurs when the diet lacks sufficient iron or the body cannot absorb iron properly- is suspected in a patient, clinicians currently face a lack of easy, affordable testing solutions for ferritin. Lateral flow ferritin tests are not quantitative and require visual interpretation. Most tests use serum that requires a lengthy preparation time and lab equipment. Hemex’s new ferritin test can use whole blood and is quantitative.
“A rapid, quantitative POC ferritin test, especially when paired with Hb Variant testing, empowers clinicians to accurately diagnose and monitor these conditions at the bedside or in remote clinics. This means faster, more targeted interventions, improved treatment outcomes, and a significant step toward reducing health disparities globally," said Dr. Jain.
The Gazelle™ Ferritin FIA Test aims to expand the reach of accurate ferritin testing for IDA for at-risk populations. Gazelle Ferritin is designed for use in non-lab settings, making it accessible for entry-level health workers without the need for specialized lab equipment. This easy-to-use, point-of-care test leverages Hemex Health’s Fluorescent Immunoassay (FIA) Technology to measure ferritin levels using whole blood, serum, or plasma. This highly sensitive diagnostic method provides an automatic analysis of a sample in 20 seconds, allowing for high-throughput testing.
“At Hemex Health, we are committed to addressing global health challenges with innovative solutions that are easy to use in challenging environments,” said Patti White, CEO of Hemex Health. “Beyond this ferritin test, our Fluorescent Immunoassay (FIA) Technology will serve as a foundation for developing additional diagnostics, specifically designed to address pressing global health challenges.”
Availability is planned for Q4 2024 in limited markets. This product is not available in the U.S. Consult www.hemexhealth.com for additional information.
Other Conference Highlights
Also at Haematocon, a panel discussion, "Next-Generation Integrated Point-of-Care Solution", supported by Hemex Dx and moderated by Dr. R.K. Jena (Professor, Dept. of Clinical Hematology, S.C.B. Medical College & Hospital, Cuttack), featured experts Dr. Tufan Kanti-Dolai (Head and Professor, Hematology Department, NRS Medical College and Hospital, Kolkata), Dr. Heena Tabasum (Scientist and Program Officer at the Indian Council of Medical Research), Dr. Isaac Odame (the Haematology Section Head in the Division of Haematology/Oncology and the Medical Director of the Global Sickle Cell Disease Network), and Dr. Umut Gurkan (Wilbert J. Austin Professor of Engineering, Case Western Reserve University, Cleveland, Ohio, USA). The panel discussed the Gazelle innovative diagnostic with AI integration and cloud data management, to enhance the early detection of sickle cell disease and hemoglobinopathies. The panel remarked that these advancements, which are aligned with the needs of India's National Sickle Cell Elimination Program, promise accessible and scalable healthcare solutions for underserved communities.
Dr. Odame noted the on-the-spot testing capability of Gazelle, which enables immediate counseling and intervention, especially in remote areas where centralized testing poses logistical challenges.
About Iron Deficiency Anaemia
An estimated two billion people are affected by anaemia worldwide, with iron deficiency anaemia (IDA) constituting 66% of total anaemia cases. IDA affects a significant portion of the population in nearly every country in the world and disproportionately affects women of child-bearing age, young children, and seniors.1
About Sickle Cell Disease and Beta Thalassemia
According to research published in Lancet Haematology by the Institute for Health Metrics and Evaluation, despite being considered a “rare” disease, sickle cell disease affects a vast number of people worldwide, with high concentrations in Africa, India, the Middle East, and some Mediterranean countries. In parts of West Africa, like Nigeria and Ghana, it can affect up to 2% of births. Nearly 8 million people were living with sickle cell disease in 2021. Similarly, beta thalassemia is prevalent in regions such as the Mediterranean, Middle East, and Southeast Asia, affecting millions globally. Both conditions significantly increase the risk of severe health complications, and individuals with these disorders are more likely to die from diseases common in these regions, such as diarrhea, pneumonia, and malaria.
The IHME report offers several policy recommendations to improve outcomes for sickle cell disease, including:
● Improving screening systems for newborns, ensuring parents are aware that their children may be vulnerable to common illnesses.
● Increasing access to treatments like hydroxyurea for sickle cell disease and chelation therapies for beta thalassemia.
● Addressing elements of structural racism that have resulted in less funding and fewer treatment options compared to other genetic diseases.
By prioritizing these measures, we can significantly enhance the quality of life for individuals affected by both sickle cell disease and beta thalassemia.
About Gazelle
Gazelle, a compact and rugged, battery-operated in vitro diagnostic platform, uses artificial intelligence, innovative optics, and miniaturization to enable a broader range of users to test for diseases in underserved areas.
Entry-level healthcare workers use Gazelle inexpensively in locations with limited access, resources, or electricity. The platform digitally captures patient information and results for storage, printing, or later transmission. Gazelle is available for identifying Hb Variants, which aids in the diagnosis of sickle cell and beta thalassemia in over 35 countries. This versatile approach will allow the company to continually add new diseases to its menu of tests and reach additional users.
Gazelle provides an accurate and rapid digital solution that operates effectively in the world’s most challenging environments. Learn more about Gazelle at https://hemexhealth.com/products.
About Hemex Health
Hemex Health impacts health outcomes in the world’s most challenging markets by developing affordable point-of-care diagnostics that quickly deliver reliable results. The company’s diagnostic solutions are affordable for both low- and high-income areas, simple enough to be used by anyone, and designed to provide reliable answers for clinicians to immediately take action. Hemex is driven to democratize diagnostics for patients with the greatest needs. The Gazelle technology was developed in collaboration with Case Western Reserve University. Hemex Health is in Portland, Oregon, U.S.A and Mumbai, India. More information can be found at www.hemexhealth.com.
1. The Lancet: New study reveals global anaemia cases remain persistently high among women and children. Anemia rates decline for men. Institute for Health Metrics and Evaluation. 7/31/2023; https://www.healthdata.org
2. World Health Organization. (n.d.). Anaemia. World Health Organization. Retrieved November 5, 2024, from https://www.who.int/health-topics/anaemia#tab=tab_1
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Country: India
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