Atomo Diagnostics' AtomoRapid HIV is an all-in-one rapid diagnostic kit that incorporates lancing, blood collection, and delivery features in a single test cassette.
Rapid testing kits are poised to disrupt healthcare by enabling faster and lower-cost testing than traditional diagnostics for a variety of diseases, leading to earlier treatment and potentially better outcomes for patients.
But there’s just one problem: Many rapid testing kits are overly complicated and difficult to use.
“The science is robust, but it’s poorly delivered,” says John Kelly, CEO of Atomo Diagnostics. “The scientists working in the IVD sector have PhDs in microbiology or clinical chemistry, but there are no mechanical engineers or industrial designers. There’s no focus on the usability of the product; it’s all about the science.”
That’s where Atomo Diagnostics hopes to make a difference. The Sydney-based company is developing a platform of all-in-one rapid testing kits backed by robust science and with an eye toward human factors engineering.
Traditional rapid diagnostic tests can have as many as five or six different parts and come with a long list of complex instructions, Kelly says. To cut down on user error, Atomo Diagnostics developed an all-in-one solution that incorporates lancing, blood collection, and delivery features in a single test cassette.
“We saw an opportunity in diagnostics for improvement of the actual form and function of the product,” Kelly says.
The AtomoRapid HIV test, launched earlier this year in Africa, was the first product in the company’s platform to come to market, and it’s already making waves. The device took home the best-in-show prize at the 2014 Medical Design Excellence Awards competition in addition to nabbing the gold in the in vitro diagnostic products and systems category. A second test, the AtomoRapid Malaria, is expected to launch sometime in the third quarter of this year.
Atomo Diagnostic’s products offer healthcare professionals a convenient solution for obtaining fast, accurate diagnoses in the field, and Kelly says the company chose to focus on HIV and malaria first because these diseases are among the most burdensome to humans worldwide.
AtomoRapid tests are currently intended to be administered by professionals, but Kelly says the company hopes to conduct studies to evaluate them for self-testing by patients soon. Atomo Diagnostics also plans to add a hepatitis C test to the platform by the end of the year, and allergy, anemia, thyroid, and anticoagulation tests could follow.
“You would buy those off the shelf in Walgreens or Walmart,” Kelly says.
The company plans to launch clinical studies to support CE Mark approval for its HIV and malaria tests later this year and is hoping for a European launch in the first half of 2015. It’s also in discussions with “large listed healthcare companies” in Hong Kong to bring the products to the Chinese market and expects an agreement there by the end of this year. Talks are also underway with distributors in Brazil, Indonesia, and Malaysia, Kelly says.
Atomo Diagnostics eventually hopes to bring its testing kits to the United States, but Kelly says the company will need help. After its founding in 2010, the company was kept afloat by its founders for 15 months before receiving an infusion of cash from angel investors as well as grants totaling just under $1 million from the Australian government. Now Kelly says the company is looking for a partner to help it launch stateside.
“We’re looking to find industry partners who can realize the potential of this technology and help us bring it to the U.S.,” he says.
—Jamie Hartford, managing editor, MD+DI