Quanterix’s AD Blood Test Gets Breakthrough Device Status; Shares Soar


Shares of Quanterix Corporation (QTRX) soared 17.4% in extended trade on Monday and 16.8% at the time of writing after the life sciences company announced that it was granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its blood test, Simoa® phospho-Tau 181 (pTau-181), which helps in diagnostic evaluation of Alzheimer’s Disease.

Quanterix’s blood test helps measure pTau-181 concentration in human serum and plasma using the Quanterix HD-X immunoassay system. (See Quanterix stock charts on TipRanks)

The designation is granted to products that FDA feels have the potential to offer a more effective diagnosis of life-threatening diseases with an unmet medical need. Notably, Breakthrough Device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved.

The Chairman and CEO of Quanterix, Kevin Hrusovsky, said, “Quanterix’s technology has the unique ability to detect low-abundance markers in a blood sample, unlocking the possibility for earlier, more accessible, non-invasive diagnosis of disease, including AD. The breakthrough designation represents an important step in our long-term strategy to develop ultra-sensitive in vitro diagnostics.”

Last month, Cowen & Co. analyst Max Masucci reiterated a Buy rating on Quanterix.

The analyst stated, “Shares have been largely range bound since pulling back from the February highs (a trend shared by several other high-growth, premium multiple companies in our space over the same period). We believe the growth drivers that support QTRX’s core neurology business remain squarely intact, and at current levels, we believe QTRX’s multiple understates its potential role in neuro clinical diagnostics.”

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Consensus among analysts is a Strong Buy based on 3 unanimous Buys. The average Quanterix price target stands at $72.50 and implies upside potential of 75.7%.

TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on Quanterix, with 6.2% of investors on TipRanks increasing their exposure to QTRX stock over the past 30 days.

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