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Alere Garners Up to $42.2M in Grants and Loans from Gates Foundation for POC MDx Platforms

NEW YORK (GenomeWeb News) – Alere said today that it has been awarded a grant of up to $21.6 million and debt financing of up to $20.6 million from the Bill and Melinda Gates Foundation to further develop a pair of point-of-care molecular testing platforms.

Under the $21.6 million grant, Alere will develop a tuberculosis assay designed for use in both resource-poor and industrialized settings.

The grant will also support Alere's efforts to incorporate one of its isothermal amplification technologies for TB detection on the Alere Q, a compact, portable device intended for molecular testing at the point of care.

Meantime, the Gates Foundation will provide below-market loans of up to $20.6 million to enable Alere to expand and scale up its manufacturing facilities in Jena, Germany, for both the POC TB test and a POC HIV viral load test that is currently in the final stages of development.

The Gates Foundation will provide these loans in exchange for commitments from Alere to make these diagnostics available at an affordable price to people in need in developing countries.

As reported yesterday by GenomeWeb Daily News sister publication PCR Insider, Alere disclosed in an earnings call earlier this month that it expected to launch a platform called qNAT outside the US later this year along with a test for HIV viral load monitoring, with future applications in hepatitis C and tuberculosis.

Alere had previously said that the qNAT platform was using a technology called competitive reporter amplification, developed in part by Clondiag, a Jena-based company that Alere predecessor Inverness acquired in 2006.

Meantime, Alere had also disclosed that it is developing a platform called iNAT for acute near-patient molecular testing, with influenza as the first target. This platform was to use recombinase polymerase amplification, an isothermal amplification method that Alere acquired along with TwistDx in 2010.

It is unclear whether the Alere Q and qNAT are the same platforms, or whether the isothermal amplification technology that will be used in the Alere Q is the RPA technology. Company officials did not immediately return a call seeking clarification.

In a statement today, the company said that it plans to deploy a "previously acquired isothermal amplification technology" for TB detection, and that the Alere Q is currently in clinical trials for near-patient HIV viral load testing.

"Merging these technologies in a single platform will play an invaluable role in combating the TB epidemic," the company said.

The platform will offer the high sensitivity and specificity needed to diagnose individuals with TB accurately, and may be used for strain and antibiotic resistance typing at the point of care, Alere said. It will also be compact, battery-powered, and easy to use, making it ideal for even the most basic healthcare settings, the company said.

Alere also said that the highly automated manufacturing processes it has built in its Jena facilities will ensure that both the instrument platform and consumables can be produced at an accessible price to enable widespread adoption. As part of the agreement, HIV test manufacturing will be fully automated and scaled to the level needed to make the product globally accessible.

Alere has begun developing the TB assay, and expects to validate it for use within the next 24 months, it said.