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ChipCare Developing Integrated Microfluidic Platform for HIV Testing at Point of Care


NEW YORK (GenomeWeb) – Toronto-based ChipCare is developing a microfluidic diagnostic platform that works similarly to a flow cytometer, but will be made available at a fraction of the cost and size.

The firm, a 2009 spinout from the University of Toronto, expects to make available a rugged, hand held system at the point of patient care, and expects to have a CE-marked HIV-related diagnostic test on the market in Africa around the end of 2017.

Using disposable cartridges, the platform performs three classes of tests – cell analysis, immunoassays, and nucleic acid testing — on a rugged, mobile platform. The firm's go-to-market assay will measure CD4 cells, a group of white blood cells that fight infection.  

Last week, the company announced that it had engaged with Biotech Alliances International as the lead investment banker for an C$18.8 million ($13.9 million) Series B capital raise. For the Series B round, the firm has already secured C$2.8 million from Series A fund investors.

ChipCare raised C$2.3 million in seed funding in 2013 of which C$1 million was raised through the Grand Challenges Canada initiative. In February 2015, the company raised C$5 million in Series A funds, and it expects to close the Series B capital raise in February.

The firm, as a first project, expects to release an assay that provides monitoring of a patient's immune status, guides the management of opportunistic infections, and monitors the effectiveness of antiretroviral therapy, James Fraser, ChipCare CEO, told GenomeWeb. The assay will provide a CD4 count using a single drop of blood within 18 minutes. 

"The test allows you to count patients' CD4 counts before treating them," Fraser said. "Sometimes, you don’t want to administer HIV treatment immediately on a patient with a very weak system, especially if the patient has acquired an opportunistic infection, such as tuberculosis," he added. "If you put them on antiretroviral therapy and their immune response is very weak, they could die."

A second assay in development will diagnose people who have HIV or syphilis using an immunoassay approach, and a third will identify infants infected with HIV using a nucleic acid approach. The third assay is also the foundation of a future HIV viral load assay, which will enable a healthcare worker to monitor the health of HIV patients while they are being treated.

"The viral load assay tells you when it is time to change to a more effective drug," Fraser said.

"We’re targeting the three main areas in diagnostics that are required to treat someone who has HIV. In the next phase of development, we expect to develop additional assays relevant in contexts with an elevated prevalence of HIV, such as hepatitis."

The diagnostic system uses a patented optical detection method that identifies multiple types of analytes, including cells, proteins, and nucleic acids. The analytes flow within channels in the fluidic chip and past a detection window accessible to a laser. A detection module counts the cells, proteins, or nucleic acids using a camera that recognizes analytes as they flow by and respond to the laser.

Counting CD4 cells is useful for monitoring immune status, but to identify people with HIV clinicians will use the immunoassay cartridge, Fraser said.

ChipCare's initial molecular test for the early diagnosis of HIV in infants will identify pathogens directly instead of antibodies, and will be most frequently deployed to test for HIV infection in infants less than 18 months old, he said. Here, the immunoassay may not be as reliable, because if a mother has HIV her antibodies may still be present in the child. Therefore, a molecular test that identifies pathogens is needed, rather than an immunoassay that measures levels of antibodies.

ChipCare’s initial target market is nine countries concentrated mostly in sub-Saharan Africa, where 20 million of the 37 million people in the world infected with HIV live, the firm said.

Diagnostic practices for remote populations tend to be inefficient and expensive, Fraser noted, and patients lose time and endure costs doing multiple trips to clinics. In addition, there are many logistic challenges with blood needing to be sent to central laboratories. Blood samples spoil, are lost, or results never make it back to the patient, he said. This leads to patients not accessing treatment, and adds substantial costs to the health system.

Morbidity and mortality rates are driven up by patients and physicians waiting for test results when therapies need to be more quickly implemented, he said.

The company has completed developing a pre-production test prototype. Its developers expect to lock down the final design in Q1 2017 and complete internal analytical studies in the following three months. ChipCare will then apply for a CE mark, and upon receipt will start selling the first assay, Fraser said.

ChipCare hopes to complete external clinical trials within three to six months after receiving the CE mark and submit the test platform and initial assay for clearance through the World Health Organization pre-qualification process.

The company plans to provide the test at a cost under $10.

The CD4 point-of-care test market is relatively small in North America, but large in low- and medium-income countries, Fraser said. He noted that the company will be able to do low-volume sales in Africa upon receipt of the CE mark. However, the WHO pre-qualification 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.

Within HIV markets, infrastructure and logistical processes are in place that allow diagnostics and drugs to reach hospitals at the community level, Fraser said. Major payors are spending billions of dollars per year to make sure people have access to treatment and care, so significant demand exists for a test such as that being developed by ChipCare, he added.

Targeting the African market also allows the firm to get a diagnostic test into the market relatively quickly. "It allows us to get a lot of experience in terms of post-market surveillance, and understand how the platform is performing and how can it be improved for future generations," Fraser said.

"The idea behind our company from the beginning has been to bring accessible diagnostics to inaccessible populations," he said. "We have taken a powerful centralized platform and miniaturized it, making it portable and taking diagnostic tests to where no one else has yet taken them" because of the capability of providing three classes of tests in one platform.

"In Africa, Latin America, and Asia, more than half of the population does not have access to diagnostics, but even if you look at Northern Canada there are 700 nursing stations that don’t have access to laboratories."

Competing point-of-care HIV tests are on the market, but ChipCare brings three classes of tests and that increases the cost effectiveness of the platform, he said.

The firm will encounter competition from established companies, such as Alere, which 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 World Health Organization prequalification, making it available for public sector procurement in resource-limited countries.

And according to OraSure, 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.