Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Sequenom (NASDAQ: SQNM) are trading roughly 10% higher today following news that the life sciences company has gained pre-market clearance from the FDA to market its IMPACT genotyping test. Sequenom is also collaborating with Quest Diagnostics (DGX +0.19%) to expand patient access to Sequenom's flagship MaterniT21 prenatal test.
So what: The IMPACT Dx Factor V Leiden and Factor II Genotyping Test, which was developed for in-vitro use to detect thrombophilia (an increased risk of blood clots) and is intended to run on the IMPACT Dx system, obtained pre-market 510(k) clearance this morning. Sequenom recently sold its bioscience segment to privately held Agena Bioscience, and this means that the clearance will transfer to Agena, in exchange for a $2 million payment. Agena now bears full responsibility for commercializing the test once all further regulatory hurdles are cleared.
The bigger news of the day appears to be that the much-larger Quest Diagnostics will offer nationwide access to the MaterniT21 test for chromosomal abnormality, and will also license Sequenom's patents to develop its own noninvasive prenatal tests for launch next year. Since Quest operates over 2,200 service centers in the United States and offers diagnostic services to roughly half of the country's physicians and hospitals, this will certainly help Sequenom expand its market quickly and without a massive self-funded marketing expenditure. The precise terms of the deal have not been disclosed.
Now what: News of the IMPACT clearance is probably irrelevant to Sequenom's future, as $2 million is barely 1% of the company's trailing 12-month revenue. However, expanded access to MaterniT21 is a big deal, especially if it helps the never-profitable Sequenom drive revenue higher with minimal additional overhead costs in marketing or customer service. However, since Sequenom has had ongoing difficulties achieving profitability despite strong revenue growth, I'd do more research -- and possibly wait to see the full terms of this agreement -- before calling this news a buy signal.
