PRESS RELEASE: Access Bio and Atomo Diagnostics announce they have developed the world’s first integrated hepatitis C rapid test for self-testing

Seoul, Korea and Sydney, Australia – 29 April 2019 | Access Bio Inc. and Atomo Diagnostics today announced that they have developed a best-in-class rapid diagnostic test (RDT) for screening for hepatitis C virus (HCV). The companies have also collaborated to create a version for professional use.  It is expected that the new tests will be made commercially available later this year.

The partnership has seen Access Bio develop the highly accurate HCV test assay, for which Atomo Diagnostics has created calibrated, fully integrated test devices.  The resulting single-use HCV tests offer unmatched performance and ease-of-use for point of care and self-testing.

These in vitro diagnostic rapid tests detect the presence or absence of anti-HCV antibodies in a single drop of blood obtained from the fingertip. The ergonomic handheld test device – with integrated sterile safety lancet, calibrated blood collection system, and unique built-in buffer delivery feature – has been designed to meet the needs of untrained lay users.  The test gives a result in minutes and is ideally suited for screening programs aimed at improving detection and facilitating access to care.

Having recently completed laboratory and in-field trials – including an evaluation overseen by the Geneva-based Foundation for Innovative New Diagnostics (FIND) – Access Bio and Atomo are now discussing with potential distribution partners to support worldwide commercialisation of the tests.

Dedicated to the prevention and early diagnosis of infectious diseases, Access Bio and its subsidiaries manufacture more than 120 million rapid diagnostic tests annually for the detection of a range of diseases, including malaria, dengue, and HIV.

“We are very pleased to have collaborated with Atomo Diagnostics to develop this self-test for hepatitis C,” said Young Ho Choi, CEO and Founder of Access Bio. “The need for new and better RDTs for HCV detection, including self-tests, has been widely acknowledged by FIND and others.  In terms of accuracy, safety, and usability, we believe that our new test is unsurpassed.  Having reliable HCV self-tests will help identify HCV patients for life-saving treatment in low- and middle-income countries, including sub-Saharan Africa.” 

Founder and CEO of Atomo Diagnostics, John Kelly, said, “We are delighted to have worked with Access Bio on this tremendously exciting project.  The lack of HCV self-tests to date has been due to the fact that errors are common with standard, multi-component RDT kits that are difficult to use.”  

Mr Kelly added,“Self-testing is an area where Atomo has particular expertise, having recently secured the first and only approval for an HIV self-test from the Australian TGA.  We have already demonstrated that our integrated RDT platforms meet the needs of self-testers, and we are confident that this new HCV test can have a significant and positive effect on infection rates globally.”

The World Health Organisation (WHO) estimates that 71 million people worldwide have chronic hepatitis C infection; with roughly 400,000 people dying from the condition each year[1]. The US Centres for Disease Control and Prevention (CDC) estimates that of the 2.4 million people in the United States living with hepatitis C virus, the majority are unaware of their infection[2].

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ABOUT ATOMO DIAGNOSTICS

Atomo Diagnostics is a world leader in medical device design and development, based in Sydney, Australia.  The company specialises in creating integrated rapid diagnostic test (RDT) platforms for blood-based testing.  The recipient of multiple international awards for innovation, Atomo’s all-in-one AtomoRapid™ handheld devices make it easy to test and screen for a range of infectious diseases and chronic conditions.  Unlike standard, multi-component rapid test kits, AtomoRapid™platforms integrate features and functionality, including built-in sterile safety lancets, calibrated blood collection systems, and unique buffer delivery mechanisms.

As well as commercialising products in its own brand, Atomo provides OEM product development services to specialist diagnostic companies worldwide. 

To find out more, visit: http://atomodiagnostics.com/

ABOUT ACCESS BIO

Access Bio (KOSDAQ: 950130) is dedicated to the prevention and early diagnosis of infectious diseases through research, development, and manufacturing of in vitro rapid diagnostic tests, biosensors, and molecular diagnostic products.  The company’s in vitro diagnostic test platform includes immunochemical, biochemical, and molecular products.

Headquartered in Somerset, New Jersey, Access Bio serves its global customer base from manufacturing sites located in the U.S., Ethiopia, and South Korea.  In 2018 the company reported $36.6 million of revenues, largely from sales of its industry-leading malaria RDT products.  The company has commercially launched a number of additional diagnostic tests that leverage its industry-leading expertise and manufacturing capacity.

For further information please contact:

Atomo Diagnostics

CEO John Kelly

info@atomodiagnostics.com

+61 (0)290994750

Access Bio, Inc.

info@accessbio.net

+1 732-873-4040