Hologic's LOCalizer RFID Tag in Breast Health Gets CE Mark

Hologic, Inc. HOLX announced an extension of its LOCalizer radiofrequency identification (“RFID”) tag’s CE Mark. Under the extended approval, the tag can now be implanted more than 30 days prior to breast-conserving surgery. The CE Mark was first received in February 2019 to be implanted within 30 days prior to the surgery.

The company believes that the new tag for long-term placement will provide more flexibility and convenience to patients as well as care providers, thus resulting in a favorable outcome. Notably, breast lesion localization methods are a component of Hologic’s breast health business.

The latest approval is expected to act as an impetus for the company to strengthen the position in the global breast lesion localization methods market.



Why is the Extension Significant?

The LOCalizer, which is a wire-free guidance system, is a non-radioactive, radiofrequency localization system, intended for precise marking and targeting of lesions in breast-conserving surgery. It is an upgradation from the traditional wire-guided localization method (which required placing the wire on the day of the surgery), thus making it possible for patients to undergo fewer interventional surgeries.

Other Developments in Breast Health Portfolio

Hologic has been focusing on its aforementioned business for quite some time now. The company acquired Faxitron Bioptics (a digital specimen radiography major) in July 2018. The LOCalizer system has become part of Hologic’s expanding breast health segment since acquired. Notably, the system is manufactured by Health Beacons and is distributed exclusively by Hologic. In January 2019, Hologic received the FDA approval for its LOCalizer.

Hologic partnered with MagView (a key mammography information solutions provider) in July to develop Unifi EQUIP. It is an automated solution facilitating compliance with the FDA’s Enhancing Quality Using the Inspection Program (EQUIP) guidance. It will be available to customers as part of the integrated Unifi product portfolio of Hologic.

In November, Hologic announced plans to launch Unifi Workspace — a comprehensive breast diagnostic reading solution. Further, the company received the FDA clearance for 3DQuorum Imaging Technology, which is powered by Genius AI, in the same month.

Apart from these, Hologic launched products like the Trident HD specimen radiography system on a global scale and the Unifi Analytics in the United States.

Industry Prospects

Per a report by ResearchAndMarkets, the global breast lesion localization methods market size is anticipated to reach $1.58 billion by 2025, witnessing a CAGR of 13.3%. The key factors driving the market are the rising incidents of breast cancer and the subsequent reimbursement policies (both government and non-government) for breast cancer diagnostics, biopsy, examination and other medical procedures.

Given the current market potential for the breast health business, the latest European approval for long-term placement in breast lesions has come at the right time.

Price Performance

The company’s shares have gained 15.7% in the past year compared with the industry’s growth of 8.1%.

Zacks Rank & Key Picks

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

Some better-ranked stocks from the broader medical space are Haemonetics Corporation HAE, National Vision Holdings, Inc EYE and ResMed Inc RMD.

Haemonetics currently has a Zacks Rank #2 (Buy) and a projected long-term earnings growth rate of 13.5%.

National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently flaunts a Zacks Rank #1.

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