Roche launches point-of-care, PCR molecular diagnostic system from $450M deal for iQuum

The cobas Liat System--Courtesy of Roche

Roche ($RHHBY) has launched the Laboratory-in-a-tube (Liat) technology it acquired when it bought iQuum in April for $275 million up front and up to $175 million in milestone payments. The cobas Liat System includes an analyzer as well as initial assays for Influenza A/B and Strep A. The analyzer and the influenza tests were already FDA-cleared and CE-marked when Roche acquired iQuum; Roche is making the system available in the U.S. and Europe.

The cobas Liat System is the only FDA-cleared molecular diagnostic platform to offer PCR results in real time, the company said. It fully automates the industry-standard polymerase chain reaction technology, providing it in a small device with results available within 20 minutes to allow for treatment decisions by healthcare providers during a patient visit. However, Roche cautions that the cobas Liat System isn't CLIA-waived in the U.S., which would allow it to be used at home.

"The cobas Liat System enables us to extend the reach of PCR technology," Paul Brown, head of Roche Molecular Diagnostics, said in a statement. "This system offers significant benefits in testing time and accuracy, over current methods used to diagnose infectious disease within the physician office or urgent care clinic. It eliminates the need for time-consuming confirmatory testing and can provide critical answers to both the healthcare professional and patient during a consultation."

In November, Roche gained FDA approval for the Strep A test, which already had a CE mark. About 37% of sore throats among children and 5% to 15% among adults are estimated to be caused by Strep A, according to the company. Once diagnosed, Strep A can be treated with antibiotics, which can prevent it from leading to serious, and even life-threatening conditions such as rheumatic fever, scarlet fever, peritonsillar abscess, necrotizing fasciitis, and streptococcal toxic shock syndrome.

In the U.S., Influenza A and B viruses are one of the leading causes of respiratory infections. Worldwide, about 20% to 30% of children and 5% to 10% of adults have the viruses with about 250,000 to 500,000 people dying annually of the flu. There are four approved influenza antivirals including Tamiflu and Relenza, according to the Centers for Disease Control. While both of these are active against both influenza A and B viruses, the other two treatments--amantadine and rimantadine--are only effective against influenza A.

Roche has said it expects a "growing portfolio of assays" to be available for the cobas Liat System but hasn't specified what it plans to target next. The system can be used in a physician clinic, pharmacy or hospital lab settings.

- here is the release

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