In its global fight against the deadly tuberculosis (TB) infection , Qiagen NVQGEN has achieved another significant milestone involving its industry-leading TB diagnosis test - the QuantiFERON-TB Gold Plus assay. Data from a key trial involving this test was recently published in the peer-reviewed European Respiratory Journal.
Notably, this multi-center trial is the first independent evaluation of Qiagen's QuantiFERON-TB Gold Plus' performance.
The aforementioned study, conducted by leading experts from 6 sites across Europe, included 225 patients, out of which 119 were active TB patients and 106 low-risk control subjects. The active TB patients included immunocompromised individuals, such as HIV infected people.
The primary end-point of the trial was to evaluate the sensitivity and specificity of the QuantiFERON-TB Gold Plus assay in detecting TB infection. The outcome validated that accurate results of this fourth-generation TB diagnostic test duly aid in detecting latent TB infection, thereby preventing vulnerable patients from becoming victims of active TB.
Evidently, QuantiFERON-TB Gold Plus demonstrated diagnostic sensitivity of 88% and a specificity of 97%. Moreover, among the challenging patients co-infected with HIV and TB, this test demonstrated 100% sensitivity.
We view these study results as a notable achievement on Qiagen's part, particularly given that the test was launched in Europe only last year. If successful, it should contribute positively to Qiagen's international test revenue. Currently, management expects to submit this test for the U.S. regulatory approval in 2016.
Moreover, investigators in this study were upbeat on the QuantiFERON-TB Gold Plus test, owing to its unique CD8 T-cell technology that allows for a distinction between CD4 and CD8 T-cell responses. According to them, this novel technology has the potential to offer additional interpretation of the TB infection spectrum and risk assessment. We believe this in turn will benefit physicians to offer more advanced treatment for their TB patients.
It is worth mentioning in this context that despite showing a declining case rate in recent years, TB infection still affects one-third of the world's population. Moreover, in HIV infected patients, TB continues to be a primary cause of death.
In this scenario, accurate and reliable diagnosis of patients with latent TB, who are at high risk of developing and transmitting the active form of the disease, is of utmost importance. Compared to the traditional tuberculin skin test, T-cell interferon-γ release assays (IGRAs) like Qiagen's QuantiFERON-TB Gold Plus offer operational advantages and higher specificity in TB diagnosis.
In fact, per Qiagen's management, this is the only TB test that offers greater than 95% sensitivity, and the highest specificity compared to any other test in the same league.
Qiagen is a key player in the global molecular diagnostics space. With the market expected to grow at a CAGR of 9.3% from 2015 through 2020, to $9.3 billion; we believe the aforementioned developments will allow the company to fetch lucrative profits in this space, going ahead.
However, consistent foreign exchange fluctuation along with an appreciating U.S. dollar, continues to hamper international growth at the company.
Qiagen currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the medical sector are Edwards Lifesciences Corp. EW , CryoLife Inc. CRY and Luminex Corporation LMNX . All the three stocks sport a Zacks Rank #1 (Strong Buy).
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