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Roche Gets FDA Nod for Expansion of Cobas 6800/8800 Systems

Zacks Equity Research

Roche Holdings RHHBY announced that it obtained FDA clearance for the expansion of the testing menu on the cobas 6800/8800 systems.

The FDA cleared the cobas TV/MG test for use of the cobas 6800/8800 systems for the detection of Trichomonas vaginalis (TV) and/or Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic patients. 

The addition of the cobas TV/MG test to the testing menu enables the identification of up to four sexually transmitted infections from one patient sample.

As a result of this clearance, laboratories can now simultaneously process sample from a single patient for the detection of combination of diseases like chlamydia trachomatis (CT), neisseria gonorrhoeae (NG), trichomonas vaginalis (TV) and mycoplasma genitalium (MG), transmitted infections (STIs), and to improve patient care.

The expansion of the test menu broadens Roche’s diagnostics portfolio. We remind investors that apart from providing therapeutic products and services for diverse medical needs, the company also focuses on innovative diagnostic solutions for the early detection and treatment of diseases. Immunodiagnostics is the key focus area in this segment. Earlier, Roche entered a long-term partnership with GE Healthcare to jointly develop and market digital clinical decision support solutions.

Roche’s stock has gained 6.3% in the past six months against the industry’s decline of 3.6%.

Meanwhile, demand for new drugs is driving growth for the company amid biosimilar competition for legacy drugs. Strong performance of Ocrevus, Perjeta, Tecentriq and Hemlibra offset lower sales of MabThera/Rituxan. In particular, MS drug Ocrevus has put up a stellar performance amid stiff competition from Biogen BIIB drugs.  The company continues to progress with its pipeline, as it looks to restructure the portfolio beyond oncology into MS and haemophilia, among others. Label expansion of Tecentriq for various indications should further boost sales.  Additionally, Roche had earlier announced that it will acquire gene-therapy company, Spark Therapeutics ONCE.

Zacks Rank & Another Stock to Consider

Roche currently carries a Zacks Rank #2 (Buy).

Another attractive stock in the healthcare space is Bristol-Myers Squibb Co. BMY, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $4.78 to $5.03 for 2020 in the past 60 days.

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