Guipry, France and Sydney, Australia, 8 November 2016 - French biotechnology company, NG Biotech, and Australian medical device innovator, Atomo Diagnostics, announced today that they have developed the world’s first fully-integrated blood-based rapid test for detection of hCG levels in pregnancy. The new product, NG-Test® Blood Precision hCG, will be unveiled this month by NG Biotech at Medica 2016 and will be launched commercially early in 2017.
Delivering highly accurate results in just 5 minutes, the NG-Test® Blood Precision hCG test uses an innovative lateral flow platform developed by multi-award winning medical device design specialists, Atomo Diagnostics, that incorporates a unique integrated buffer delivery mechanism.
Testing of hCG (human chorionic gonadotropin) levels is routinely performed in emergency departments when a female patient is admitted with abdominal pain or bleeding. In the region of 20 million hCG tests are performed annually in the US and Europe and, in such cases, either laboratory-based blood analysis is carried out, giving a result in 1 to 2 hours, or a urine rapid test is performed, with results available in 20 to 40 minutes.
Urine rapid tests have previously been seen as quick and easy but have proven to be problematic in busy primary care environments. Sample collection can be challenging and time intensive, and urine is a less sensitive sample medium than blood. Insufficient or diluted urine samples can also affect test accuracy and cause false negative results.
In addition, because of the time taken to obtain results, use of blood-based hCG tests in critical point of care (POC) settings has been far from ideal. The new rapid hCG blood test from NG Biotech and Atomo improves greatly on what has gone before, rivalling laboratory-based blood analysis in terms of accuracy. The test has been designed specifically to simplify the test procedure and to reduce the number of user steps by integrating all necessary components into one intuitive, single-use device. The test will mitigate problems commonly associated with standard rapid diagnostic test (RDT) kits; particularly those relating to insufficient blood sample, difficulty with blood collection or transfer to the platform, improper use of buffer or inadequate buffer volume delivery.
Unlike standard, multi-component rapid RDT kits, the device platform designed and developed by Atomo incorporates a built-in safety lancet, unique blood collection and delivery system, and integrated buffer delivery feature, which collectively help to prevent user-related errors and improve test performance. Improved usability means this new test could potentially be performed by untrained health technicians and diagnostic decisions can be made more promptly, saving time and cost.
Milovan Stankov Puges, CEO of NG Biotech said, “We are proud to have partnered with Atomo Diagnostics to develop our next generation hCG blood test. By combining the talents of our respective companies, we have created a product that addresses unmet user needs in POC testing with superior accuracy, usability and simplicity. We hope and believe that this will be but the first of many collaborative projects that draw on the assay development expertise of NG Biotech and the device design capabilities of Atomo.”
NG Biotech and Atomo Diagnostics are also partnering to develop new test applications for OTC and POC markets worldwide.
John Kelly, CEO of Atomo Diagnostics said, “Atomo has always been committed to improving POC diagnostics by reimaging what has gone before. Our all-in-one AtomoRapid diagnostic test devices are designed to overcome the user issues and reduced levels of sensitivity common with in-field deployment of multi-component test kits. The team at NG shares our passion for innovation and we look forward to extending the scope of our partnership in the future.”
From 2017, NG-Test® Blood Precision hCG will be available for use throughout Europe and, thereafter, regulatory approval will be sought for commercialization in the US. Additionally, because of its unmatched usability, NG Biotech intends to seek regulatory approval for an OTC version for lay users. This will give women the ability to test for pregnancy at an early stage, with the greater convenience and precision offered by painless blood-based testing. Requiring only a small blood sample of 10uL collected easily and comfortably from the fingertip, the test will deliver a highly accurate result at any time of day, in contrast to urine tests that have to be used with the first morning urine for utmost accuracy in early stage pregnancy.
The new hCG blood test from NG Biotech will be unveiled at Medica 2016 – World Forum for Medicine trade fair, Dusseldorf, Germany, 14 - 17 November. The world’s largest medical trade fair, Medica attracts in the region of 5,000 exhibitors and 130,000 visitors from 120 countries annually.
About Atomo Diagnostics
Atomo Diagnostics is a medical device design and manufacturing company, based in Sydney, Australia, with corporate offices in the UK and South Africa. The company specializes in developing innovative rapid diagnostic test (RDT) platform devices for capillary blood samples. Atomo’s refreshing, user-centered approach to design and willingness to reimagine what has gone before has led it to create products that are simpler to use and that help prevent common user errors associated with standard RDT kits. The recipient of multiple international awards for design innovation, Atomo’s all-in-one platform devices put the end user first and make it easy to test and screen for a range of infectious diseases and chronic conditions. As well as commercialising products in its own brand, Atomo provides OEM product development services to specialist diagnostic companies worldwide. www.atomodiagnostics.com
About NG Biotech
Founded in 2012, NG Biotech is a biotechnology company that is leading development of m-Health solutions for in vitro diagnosis, prognosis and therapy monitoring for human and veterinary applications. With 30 years’ experience in the development and commercialisation of POC diagnostics, the company has developed and patented a proprietary immunoassay platform enabling development of quantitative and multiplex rapid tests with the potential to detect up to nine different biomarkers simultaneously. The platform can be adapted to detect or monitor any kind of antibody, antigen, pathogen, parasite, hormone or drug. The tests are then associated to wireless mobile readers. Results are obtained in a few minutes from a single drop of blood (or other type of sample) and can be communicated to a server or cloud for further data sharing and management. NG Biotech markets a range of CE marked rapid tests worldwide. Product validations are performed in comparison to laboratory standard reference methods as Elisa or PCR. The company is certified to ISO 9001 and ISO 13485, and FDA CFR 21 part 820 is in process. www.ngbiotech.com
Issued for and on behalf of Atomo Diagnostics.
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