NEW YORK (GenomeWeb) – Diagnostics firm Alere announced this week it obtained CE marking of an HIV detection assay that runs on its Alere q platform.
The Alere q platform was itself CE marked last July, and is the second of two nucleic acid amplification platforms the firm originally described in 2012. The company's other molecular platform, the Alere i, recently received FDA clearance and CLIA waiver for an associated influenza test, and won $12.9 million in funding to further develop the system for pandemic flu preparedness.
Stuart Cassey, vice president of infectious disease global marketing at Alere, provided an update today regarding the sales and marketing strategy for the Alere q platform and tests.
Initial commercial focus will be in 21 sub-Saharan African countries that have high HIV prevalence, Cassey said, with commercialization in Europe, Asia, and Latin America to follow in the second half of 2015.
This timeline is in line with previously described intentions for the platform, which Alere had also said will run three different HIV testing products.
John Wisson, director of new product development for acute infectious diseases at Alere's UK offices, told GenomeWeb in October that the Alere q HIV 1/2 Detect test is intended for early diagnosis in infants and acute HIV diagnosis in high-risk adult populations. The company is also developing an HIV viral load test for whole blood and one for plasma, and had submitted for World Health Organization prequalification, Wisson said at that time.
In a conference call to report the firm's earnings last month, Alere CEO and President Namal Nawana said the Alere q platform would have a limited launch this year for early infant diagnosis of HIV in Africa, and that the company would expect sales from that.
Cassey further explained this week that the Alere q "was designed and engineered to operate in diverse and challenging environments." He noted that it is battery-powered and portable, with a fully automated analyzer and a cartridge system that "eliminates the complexity of molecular diagnostics for the operator."
"This offers the potential for Alere q to be deployed closer to the patient, lower down in the healthcare setting pyramid," Cassey said.
A study last year validated the Alere q HIV 1/2 test for early infant diagnosis in five clinics in Mozambique.
In terms of the molecular methodology, Alere i tests use one of two isothermal chemistries, and provide results in less than 15 minutes. Alere q, on the other hand, utilizes a multiplexed real-time PCR methodology that allows amplification and detection of multiple targets at the same time, Cassey said.
"In the case of Alere q HIV 1/2 Detect, the test can identify and distinguish between HIV 1 subgroup (M/N), HIV 1 subgroup (O), and HIV 2 in under 60 minutes, [and] Alere q also offers the capability of delivering quantitative results," he said.
"We feel having two platforms with differing capabilities gives us greater flexibility to take advantage of all the potential applications, sample types, and care settings found in the global market," Cassey added.
Alere anticipates bringing the HIV viral load assay to market later in 2015, Cassey said. The firm is also currently developing assays on Alere q for Ebola, TB diagnosis, TB drug resistance testing, and hepatitis C testing.
Firms like Quidel and Cepheid are also developing or manufacturing molecular diagnostics platforms for low-resource settings, and have described similar test menus. It is unclear how these will ultimately compete, but subsidies could play a role.
Development of a low-cost, rapid, quantitative HIV test on Quidel's Savanna platform has been funded by grants from the Bill and Melinda Gates Foundation, as previously reported.
Cepheid's Xpert HIV-1 Viral Load assay is expected to begin shipping this month to customers in countries that accept CE marking. Under the auspices of ongoing TB eradication efforts, the Cepheid Xpert platforms have now been placed in 116 of 145 high-burden and developing countries under specially negotiated concessional pricing in a program managed by the Foundation for Innovative Diagnostics and the World Health Organization. As of December 31, 2014, WHO reports 3,763 instruments procured at a concessional price of around $17,000 each, excluding warranty costs and the price of test cartridges.
The Alere q, by comparison, "is approved by the Global Fund’s Expert Review Panel for Diagnostics process ... has been submitted for WHO pre-qualification, and is currently going through the registration process in various countries," Cassey said.
He further pointed out that Alere has "an established sales, marketing, and support infrastructure in developing world countries."
The platform also offers interesting options for data access and processing that may differentiate it from competitors.
Its Data Point connectivity package delivers analyzer results to a central server, enabling customers to access data. "Regardless of how many analyzers are in the field, the portal allows near real-time monitoring of data, including usage patterns, device condition, and stock management," Cassey said.
Alere also offers products "for the complete continuum of HIV care, from initial screening and diagnosis, to staging, to ongoing monitoring," he noted.
"Molecular diagnostics at the point of care, with platforms like Alere i and Alere q, has the potential to be transformational in the field of diagnostics. Alere will continue to add content on these platforms and innovate in this area," Cassey asserted.
As far as additional regulatory intentions for Alere q in the US market, Cassey said that pursuit of FDA clearance is under consideration.