NEW YORK (GenomeWeb) – Sydney-based Atomo Diagnostics has a parallel approach to growth built on lateral flow technology. Its strategy involves integrating multiple components from business partners into an Atomo-branded diagnostic platform, while operating as an original equipment manufacturer that produces diagnostic test systems with partner companies.
The Global Health Investment Fund appears to value the strategy, as well as Atomo's product and services portfolio. In January, GHIF — which invests in medical technologies to aid low and middle-income countries — provided a loan to Atomo to the tune of A$8.5 million (US$6 million) for commercialization of professional and self-test diagnostics for HIV and other infectious diseases. The deal was structured by JP Morgan Chase and the Bill & Melinda Gates Foundation, with founding support from Grand Challenges Canada, the German government-owned development bank KfW, and the Swedish International Development Cooperation Agency, Atomo said.
The firm then followed that up by raising A$4.5 million in equity funding in August from investors including additional funding from GHIF and new funds from a company associated with Allan Moss, former managing director and CEO of the Macquarie Group investment bank. With this second round of investment this year, GHIF's fund manager Curt LaBelle joined the Atomo board.
In November, the firm announced that it had been working with Guipry, France-based NG Biotech to develop an integrated blood-based rapid pregnancy test that analyzes human chorionic gonadotropin levels. NG Biotech unveiled the test at Medica 2016, an annual medical trade fair, in Dusseldorf, Germany after meeting with Atomo to discuss the beginnings of a partnership at Medica 2015.
In 2017, the NG-Test Blood Precision hCG will be available for use throughout Europe, according to NG Biotech. After launch, the firm will seek regulatory approval for commercialization in the US, and for an over-the-counter version.
Improved usability means this new test could be performed by untrained health technicians, and diagnostic decisions can be made more promptly, saving time and cost, according to NG Biotech.
As part of the project, Atomo Diagnostics contributed to key components to its design and development including a “unique integrated buffer-delivery mechanism,” Hans Fredman, Atomo’s chief commercial officer, told 360Dx.
"The clinical community has accepted that a blood test for early detection of pregnancy is an important tool," he added.
The market opportunity for Atomo could be significant. Healthcare workers implement around 20 million hCG tests annually in the US and Europe. Clinicians routinely test for hCG levels in emergency departments when a female patient is admitted with abdominal pain or bleeding. They use lab-based blood analysis, which produces a result in one to two hours, a timeframe that can be problematic, or a urine rapid test, which produces a result in 20 to 40 minutes, according to Atomo.
Urine rapid tests have proven to be problematic in busy primary care environments, the firm said. Sample collection can be challenging and time intensive, and urine is a less sensitive sample medium than blood, Atomo added. Insufficient or diluted urine samples can also affect test accuracy and produce false-negative results.
Meanwhile, the use of laboratory-based hCG tests in critical point-of-care settings can take too much time to produce results, Fredman said.
He noted that the NG and Atomo rapid hCG blood test competes on accuracy with laboratory-based blood analysis, produces results in five minutes, and has been designed to mitigate problems ordinarily associated with some standard rapid diagnostic test kits — such as insufficient blood samples — challenges associated with collecting or transferring blood to the platform, and delivery of inaccurate buffer volumes.
The device platform designed and developed by Atomo incorporates a built-in safety lancet, a unique blood collection and delivery system, and an integrated buffer delivery feature, which collectively help to prevent user errors and improve test performance, Atomo said.
NG Biotech CEO Milovan Stankov Puges said that he believed that this will be “the first of many collaborative projects that draw on the assay development expertise of NG Biotech and the device design capabilities of Atomo.”
The companies are collaborating to develop new test applications for over-the-counter and point-of-care markets.
Automating lateral flow testing
CEO John Kelly founded Atomo Diagnostics in 2010 with a view to creating a value proposition based on integrating the multiple components that are part of rapid lateral flow tests, Fredman said.
Once the platform architecture was in place, the founders believed that it would then be possible to work on adding tests for different diseases and parameters to the platform, he said.
The firm decided to initially produce an HIV test system, partly because of the level of available funding for HIV testing and treatments, and because of the global need for and potentially broad impact of such a test, Fredman noted.
“We are responding to objectives of major organizations, including the World Health Organization and the United Nations, that have set targets to have at least 90 percent of HIV-infected people diagnosed by 2020," he said. "If we could prove that the test would work on our platform, we knew that it would establish a foundation for adding additional types of tests for other diseases and parameters."
Fredman noted that designing tests that integrate multiple components has been an important feature and differentiator. It meant that healthcare workers can complete each testing step in a logical, stepwise, and error-free fashion, he said. Importantly, the company's diagnostic system completes an HIV test within 15 minutes, and lateral flow tests for most disease areas can be completed in between 10 and 20 minutes, he added.
Citing an example of Atomo's design innovation, Fredman noted that although its current generation of HIV test has a separate buffer solution, the pregnancy test developed with NG Biotech integrates the buffer solution into the cartridge. This is among the first lateral flow tests on the market with an integrated buffer solution, which guarantees the correct buffer volume and reduces the potential for user errors, he added.
In addition to the assays for pregnancy and HIV, the platform could accommodate diagnostic tests for dengue, chikungunya, Ebola, hepatitis C, Zika, and troponin, he said.
“Rapid lateral flow tests are a relatively inexpensive alternative to competing tests, and they can be done almost anywhere without requirements for additional equipment,” Fredman said.
Atomo is working with two partners to integrate test strips for Zika antibody detection with the Atomo platform, he added.
HIV self-testing
Along with work to integrate the Zika antibody test and develop the rapid pregnancy test, the firm is continuing work on its HIV test system as part of its product portfolio.
Clinicians require multiple devices and accessories while performing current rapid HIV tests, which leaves room for sources of error that can yield false negatives in the field, according to Atomo. To be truly effective, rapid HIV tests need to be easy to use, safe, and accurate, the firm said. It noted that the Atomo Rapid HIV test system was designed to address limitations presented by existing tests. The lancing, blood collection, and delivery features, for example, are all integrated into the test cassette, making it easier, quicker, and safer to use, Atomo said.
A lancet initiates a blood draw upon contact with skin, and a capillary tube then automatically collects 10 microliters of blood required to conduct the blood test. The test system always delivers an accurate volume of blood to the correct position and automatically dispenses blood to the HIV test strip upon contact, Atomo said. The firm noted that accuracy is improved because this type of design eliminates the need to manually collect and deliver a specific volume to the correct part of the test, which could lead to errors.
Atomo is working to expand into self-testing for HIV. Through the next year, the firm will work on redesigning its current platform so that it is easier to use and more suitable for the self-test market, Fredman said. The firm will apply for a CE mark and WHO prequalification. The firm expects to have the new CE mark around April 2017.
Earlier this year, the firm received a CE mark for its HIV test. Atomo had been marketing the test in South Africa, and was preparing marketing efforts for Europe, the Far East, and other countries in Africa.
However, Atomo’s test supplier, altering its strategy, decided that it wanted to brand its own test and not pursue work with Atomo, Fredman said. As a result, the firm found a new test partner and is again seeking the CE mark, along with WHO prequalification, through which it plans to market its diagnostic test kit for professional and self-test applications.
The WHO prequalification is a universal mark of approval, and would potentially open access to the test for large global buyers who are interested in high volumes and require the WHO prequalification, James Fraser, CEO of ChipCare, which is developing a microfluidic diagnostic platform for HIV testing, recently told GenomeWeb.
Major payors are spending billions of dollars per year to make sure people have access to treatment and care, so significant demand exists for point-of-care HIV testing, he added.
Atomo will encounter competition from established companies in the markets for HIV and early pregnancy testing.
Alere, for example, announced this past July that its rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen had been awarded WHO prequalification, making it available for public sector procurement in resource-limited countries.
OraSure noted that its HIV 1/2 antibody test has been widely used to identify HIV infection outside of traditional laboratory settings. The OraQuick In-Home HIV test, a rapid over-the-counter antibody test, is approved for sale in the US.
WHO also has prequalified Becton Dickinson's BD FACSPresto Near-Patient CD4 Counter system to determine eligibility for initiation of antiretroviral therapy, staging of the disease, and monitoring of HIV-infected patients in middle- and low-volume testing laboratories.
Within the markets for early pregnancy detection, Medical Innovation Ventures (Mediven) received the CE-IVD mark in June for rapid tests that detect the presence of hCG in urine during the early stages of pregnancy.
In April, Spanish clinical diagnostics firm Stat-Diagnostica said that it had closed a Series C financing round for €25 million ($28.5 million) to prepare for the 2017 launch of its DiagCore integrated molecular and immunoassay near-patient testing system. Its Stat-Immuno cartridge is designed to automate high-sensitivity immunoassays for critical care markers, including hCG for pregnancy, among others.
BioMérieux's bioNexia hCG panel includes two rapid chromatographic tests — one for urine only and another combo diagnostic test for urine or serum. And Alere offers several hCG tests designed for laboratory and point-of-care testing, including in emergency departments, physicians' offices, and health centers.