Hologic (HOLX) Receives PMA for Aptima HIV-1 Quant Assay

An image of a quarterly report on a screen
Credit: Shutterstock photo

Diagnostic instruments major Hologic, Inc.HOLX recently announced the receipt of the FDA's Premarket Approval (PMA) for its Aptima HIV-1 Quant assay. This viral load monitoring assay falls under the company's Diagnostic Solutions division. It is a nucleic acid amplification test for the quantitative identification of RNA from HIV in plasma specimen.

The assay runs on Hologic's advanced integrated platform - Panther system - that fully automates all aspects of testing, from sample to results. The system significantly brings down hands-on time for laboratories by providing random and continuous access with rapid turnaround time. However, the test is not approved for HIV-1 diagnosis in the U.S.

Meanwhile, over the last six months, Hologic has outshined the Zacks classified Medical - Instruments industry trend. The stock price has climbed 15.1%, way better than the 3.6% decline of the broader market. The company also recorded a five-year revenue CAGR of 9.1%, reflecting strong fundamentals.

While we await the company's first-quarter 2017 earnings announcement in a month or less, we note that, Hologic posted a top and bottom-line beat in fiscal 2016. Moreover, the company observed gross margin expansion on the back of strong domestic sales, favorable product mix and operational improvement. The Diagnostics solutions segment, which currently has bright prospects, grew 2.5% year over year to $311.9 million in the quarter.

Coming back to the news, multiple studies have compared the performance of the Aptima HIV-1 Quant assay with other existing HIV viral load monitoring assays. The results demonstrated that the new assay offers repeatable, reliable and consistent quantitation across HIV-1 groups and subtypes. This consistency is critical for patient management as it ensures that detected changes in viral load are due to potential clinical changes rather than assay variation. The Hologic Aptima HIV-1 Quant assay uses a dual target approach against highly conserved regions in the HIV genome. Combining the assay with Panther system enables clinicians to complete every step from sample to result within a single integrated instrument.



Interestingly, a Grand View Research report states that the global HIV Diagnostics market is expected to reach a worth of $4.48 billion by 2022, at an estimated CAGR of 9.5%. Key factors accounting for growth in this market include the increasing need for development of more sensitive HIV diagnostic point of care tests which can be easily implemented at the location of patient care in resource limited settings.

Hologic is constantly making efforts to fortify its position in the virology space by offering qualitative assays for HIV and HCV. The company's recent development includes the receipt of CE Mark for its Herpes Simplex Virus (HSV) assay. In the past quarter as well, Hologic's Aptima Zika virus diagnostic assay got FDA's expanded emergency use authorization for urine samples. Management claims that the combination of performance and automation will help labs become more efficient in meeting current demand for HIV treatment monitoring.

Zacks Rank & Key Picks

Hologic carries a Zacks Rank #3 (Hold). Better - ranked medical stocks are NxStage Medical Inc. NXTM , Align Technology, Inc. ALGN and Haemonetics Corporation HAE . NxStage Medical and Align Technology sport a Zacks Rank #1 (Strong Buy) while Haemonetics carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here.

NxStage Medical gained 24.1% over the last one year compared with the S&P 500's 11.9%. The company has a four-quarter average positive earnings surprise of 46.3%.

Align Technology rallied 49.3% in the past one year, way better than the S&P 500's 10.1%. It has a trailing four-quarter average positive earnings surprise of 23%.

Haemonetics recorded a 25.8% gain over the past one year, better than the S&P 500. It has a trailing four-quarter average positive earnings surprise of 0.82%.

Zacks' Top 10 Stocks for 2017

In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?

Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

HOLOGIC INC (HOLX): Free Stock Analysis Report

HAEMONETICS CP (HAE): Free Stock Analysis Report

NXSTAGE MEDICAL (NXTM): Free Stock Analysis Report

ALIGN TECH INC (ALGN): Free Stock Analysis Report

To read this article on click here.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story


Other Topics


Latest Markets Videos