Focus Diagnostics gets FDA blessing to expand label for herpes test

Quest Diagnostics' ($DGX) Focus Diagnostics unit nabbed FDA clearance to add a genital swab claim to the label of its rapid herpes test, furthering the company's forward-reaching momentum as it attempts to revive sales and rev up R&D.

The FDA blessing clears genital swabs for use with Focus' Simplexa HSV 1 & 2 Direct molecular test, which is already approved by the FDA to screen for the virus. Simplexa runs on an Integrated Cycler, and uses PCR to detect RNA in viruses and bacteria through a quick, proprietary method.

The test was originally approved to check cerebrospinal fluid (CSF) from patients suspected to have HSV central nervous system (CNS). But herpes can produce sores in other locations, the company said in a statement, calling for a more comprehensive approach to testing.

"With nearly one in six adults 49 and younger infected with genital herpes, reliable, speedy diagnosis is key to patient care. The added genital swab claim significantly broadens our test's potential clinical utility as an aid in diagnosing infection with one or both herpes simplex viruses," Michelle Tabb, VP of research and development for Focus Diagnostics, said in a statement.

Meanwhile, Focus is charging ahead with its other products. In April, the Cypress, CA-based company scored FDA 510(k) clearance for its Simplexa Group A Strep Direct test, which uses real-time PCR technology to pinpoint bacterial DNA and RNA from throat swabs in as little as an hour.

Quest Diagnostics CEO Steve Rusckowski

Focus' success also bodes well for Quest, which has been working hard to deliver on a 5-point plan to revive its lagging fortunes. In 2014, the company kicked things off by implementing a series of job cuts, managerial changes and reorganization, and also started shopping around for deals.

Last year, the company snatched up Solstas Lab Partners for $570 million to gain ground in the southeastern U.S. Earlier this year, Quest said it would team up with global CRO Quintles ($Q) for a JV aimed at providing lab services and diagnostics for clinical trials. Together, the companies will create the second-largest provider of central lab services that would have brought in $575 million in revenues in 2014.

At least for now, Quest's hard work seems to be paying off. The company reported Q1 revenues of $1.8 billion and is shooting for 2% to 3% growth in 2015. "We're pleased with the continued progress we're making against our 5-point strategy," Quest CEO Steve Rusckowski said earlier this year.

- here's the statement