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Hologic Gets WHO Prequalification Approval for HIV Assay, Offers $950M in Senior Notes

NEW YORK ─ Hologic on Monday said that the World Health Organization has granted prequalification approval for its Aptima HIV-1 Quant Dx assay for the testing of dried blood spot samples.

Separately, the Marlborough, Massachusetts-based company announced a private offering of senior notes due in 2029 in the aggregated principal amount of $950 million.

The Aptima HIV-1 Quant Dx assay can be used with dried blood spot samples to monitor viral load and disease progression among HIV-1 infected people and to aid in the diagnosis of HIV-1 infected infants under 18 months. According to Hologic, this is the first dual-claim assay for both viral load and early infant diagnosis.

WHO prequalification signifies that its product meets global standards of quality, safety, and performance, and that the United Nations and other procurement agencies such as PEPFAR (The US President's Emergency Plan for AIDS Relief), Unitaid, and the Global Fund use the designation to make purchasing decisions.

The dried blood spot is the primary sample type in several African countries, so the WHO prequalification approval will enable these countries to expand their use of the Aptima HIV-1 Quant Dx assay, Hologic said.

In February 2019, Hologic received CE marking for use of the assay in the testing of dried blood spots and for the early diagnosis of the disease in infants.

The assay is being offered as part of the Hologic Global Access Initiative (GAI), launched in 2018, which offers customers a single, all-inclusive pricing structure with no upfront cost or capital expenditure, Hologic said.

Hologic noted that dried blood-spot sampling improves access to HIV diagnostic testing and care, particularly among HIV-infected populations living in remote areas. Dried bloodspot samples are more stable and easily transportable compared to liquid whole blood or plasma samples. A finger stick or heel prick produces an adequate sample that is dried on a specially designed card. Dried blood spot samples do not require refrigeration and when they are stored properly, they can withstand extreme conditions, including excess heat and humidity.

Regarding its private offering of new notes, the firm said the senior notes will be unsecured obligations of Hologic and guaranteed by certain Hologic subsidiaries. The company intends to use the net proceeds of the offering, plus available cash, to redeem in full all of its outstanding 4.375 percent senior notes due in 2025 in an aggregate principal amount of $950 million. The company will redeem the 2025 notes on or about Oct. 15.

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