A Diagnostics & Imaging Week

Hologic (Bedford, Massachusetts) and Cytyc (Marlborough, Massachusetts) last week reported the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, in connection with the companies’ pending $6.2 billion merger.

The expiration of the waiting period satisfies one of the conditions to the closing of the merger. Based on the review and analyses performed by Hologic and Cytyc, the parties do not believe any further antitrust approvals are required to complete the transaction.

The companies entered into a definitive agreement in May to merge in a cash and stock transaction, under which Cytyc shareholders would receive 0.52 shares of Hologic common stock and $16.50 in cash for each share of Cytyc common stock they own.

The transaction is subject to approval of both companies’ shareholders as well as other customary closing conditions and is expected to close in the 3Q07.

Hologic is a developer of diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a developer of imaging technology for digital radiography and breast imaging.

Cytyc develops diagnostic and surgical products covering a range of cancer and women’s health applications, including cervical cancer screening, preterm birth screening, treatment of excessive menstrual bleeding, radiation treatment of early-stage breast cancer, and radiation treatment of patients with malignant brain tumors.

In other dealmaking:

Calypte BioMedical (Lake Oswego, Oregon), a medical diagnostic tests manufacturer for the rapid detection of antibodies to the human immunodeficiency virus (HIV), reported that it has leased an 11,000 sq. ft. site in Portland.

Calypte said the site permits the consolidation of its research laboratory and administrative functions and will become the company’s new headquarters. The site also provides manufacturing space which the company said it plans to utilize to build pilot lots for clinical trials in the U.S.

The company expects these studies to be a prelude for submitting a formal application for approval with the FDA.

“This facility is our first step in reestablishing our presence in the U.S. diagnostic test market and moving toward approval of our Aware HIV- 1/2 oral test in the U.S. We plan to start by commencing the process of filing for FDA approval of an oral fluid test for professional use,” said Roger Gale, CEO and chairman of Calypte.

“One of the uses of funds from the recently-completed PIPE is to advance our efforts to market our oral fluid tests in the U.S. market,” Gale said. “Calypte has invested over $3 million to acquire technology and equipment to take advantage of this opportunity. While multiple outcomes are possible, our objective for beginning the FDA regulatory process is to ultimately receive approval for manufacturing and distribution of an over-the-counter oral fluid HIV diagnostic test in the U.S.”

Calypte said it will occupy the new facility in September.