Atomo_Malaria-KS__5758-ret1At the recent AACC conference in Chicago, Atomo Diagnostics, a healthcare company based in Australia, introduced what it calls “the world’s first integrated rapid blood test device.” The AtomoRapid test processes test strips for a wide variety of conditions, including celiac disease, allergies, malaria, and HIV.

The device, which is approximately half the size of an iPhone, has already been used in South Africa for HIV and malaria testing. According to founder and CEO John Kelly, regulatory efforts in Europe and the United States are under way, with CE marking expected by early 2015 and FDA approval anticipated in the first quarter of 2016.

John Kelly, CEO, Atomo Diagnostics

John Kelly, CEO, Atomo Diagnostics

“We have started with HIV and malaria because that was where false negatives and false positives from other existing ‘bits in a box’ products—which were sometimes greater than 10% when used in the field—were having the most significant impact on individuals,” Kelly said. “Over 100 million rapid HIV tests are bought each year globally, and Atomo Diagnostics is leading the transition to a more user-friendly all-in-one solution with its AtomoRapid innovation.”

The HIV version of the device uses a test strip evaluated by the World Health Organization (WHO) and is intended to improve the reliability of testing at home and in the community. Australia currently bans home HIV testing. According to the most recent annual HIV surveillance report from the University of New South Wales’ Kirby Institute, about 30% of Australians with HIV are diagnosed after they should have already started treatment.

“Existing tests fail to offer the AtomoRapid all-in-one solution, which can leave them open to errors, which in turn creates misdiagnosis. This can have a significant impact not only on the individual, but the community too,” Kelly said.