Hologic's Aptima Genitalium Assay Gets Clinically Verified

Hologic’s (NASDAQ:HOLX) Aptima Mycoplasma genitalium assay recently attained significant recognition based on a positive study outcome. A prospective, multi-center Aptima Mycoplasma genitalium Evaluation Study (AMES) has become the first clinical research to approve the performance of Aptima Mycoplasma genitalium assay in the United States.

For investors’ note, Hologic’s Aptima Mycoplasma genitalium assay is the first-of-its-kind, FDA-approved assay which can be used to diagnose the sexually-transmitted bacterium Mycoplasma genitalium (M. genitalium).

The AMES study result is anticipated to be a major stride forward in the company’s commitment toward strengthening its Diagnostic Solutions business.

More About the Study

The clinical study assessed the prevalence, sensitivity, specificity, positive predictive value, and negative predictive value for the Aptima assay compared to a composite molecular reference standard.

The study assessed 3,300 sexually active women and men between the ages of 15 and 82, at 21 sites across the United States. The M. genitalium incidence rate was found to be 10.1% in women and 10.6% in men. In symptomatic women and men, the prevalence was found to be 11.6% and 12%, respectively. The prevalence was 7.9% and 8.8%, in asymptomatic women and men, respectively.

Hence, the AMES study proves that the incidence rate of M. genitalium was high in both symptomatic and asymptomatic women and men. This is why accurate diagnostic tests, such as the Aptima Mycoplasma genitalium assay, are instrumental in accurately identifying and treating specific bacterial infections.

Results showed that for each of the seven specimen types, Aptima assay results were closely in line with the results attained with the composite reference standard.

According to Hologic, these study results will enable clinicians to choose the specimen type most suited for their patients. Moreover, the availability and clinically-proved efficacy of the Aptima Mycoplasma genitalium assay suggests that validation of laboratory-developed tests for detection of the organism would no longer be necessary.

Market Prospects

Per a market research report by Technavio, the global bacterial disease diagnostics market is expected to witness a CAGR Of 6% during the five-year period (2019-2023). Hence, this study result comes at an ideal time.

Recent developments

Of late, Hologic has been investing in several developments to fortify its Diagnostics solutions business.

In May 2019, Hologic attained FDA clearance for its new Aptima BV and Aptima CV/TV assays, which specialize in providing a precise and unbiased method for detection of vaginitis, a very common and complex health issue that millions of women suffer from every year. This regulatory approval is expected to have boosted the company’s Diagnostics solutions business.

Price Performance

The company’s shares have rallied 13.1% in the past year, compared with the industry’s gain of 5.8%.

Zacks Rank & Key Picks

Currently, Hologic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Haemonetics Corporation (NYSE:HAE) , NuVasive, Inc (NASDAQ:NUVA) and GW Pharmaceuticals plc (NASDAQ:GWPH) .

Haemonetics, currently sporting a Zacks Rank #1 (Strong Buy), has a projected long-term earnings growth rate at 13.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

NuVasive, with a Zacks Rank #2 (Buy), has an expected long-term earnings growth rate of 10.9%.

GW Pharmaceuticals estimates fourth-quarter earnings growth rate at 67.9%. It currently carries a Zacks Rank of 2.

Looking for Stocks with Skyrocketing Upside?

Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.

Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.

See the pot trades we're targeting>>