Leica, Aperio, Myriad, AMP, Hologic, Gen-Probe


FOR THE SECOND TIME IN AS MANY YEARS, a global leader in histology systems and products has announced that it will acquire one of the leading digital pathology companies. This time it is Leica Biosystems of Nussloch, Germany, which will purchase Aperio Technologies, Inc., of Vista, California.

Founded by Dirk Soenksen in 1999 in his garage, Aperio grew steadily and has stated that it has more digital pathology systems in use around the world than any other digital pathology company. In recent years, the company has acknowledged an installed base of more than 700 systems in 30 countries.

Leica’s strategy is to develop an integrated suite of pathology products and systems that include histology and the pathologist review of the case. There is the opportunity to develop proprietary assays that incorporate both specimen processing and diagnosis of the resulting images.


IT’S BEEN AN EVENTFUL YEAR for legal cases challenging gene patents. In the case of Association for Molecular Pathology v. Myriad Genetics, Inc., the latest development came on August 16, 2012.

That is the day when the U.S. Court of Appeals for the Federal Circuit (CAFC) confirmed an earlier ruling that DNA molecules isolated from their natural state are patentable subject matter. The Supreme Court had earlier directed the appeals court to review its previous decision in this high-profile legal case.

In commenting on the matter, the law firm Bradley Arant Boult Cummings, LLP, in Birmingham, Alabama, said, the ruling means “that certain method claims directed to identifying anti-cancer compounds were patentable, but certain diagnostic method claims directed to methods of analyzing and comparing the sequences of DNA molecules were not patentable.”

This ruling is significant because, “While this decision protects inventors’ rights in isolated DNA molecules and some methods of using isolated DNA, this decision casts some uncertainty in the area of patentability for diagnostic genetic testing,” it added.

Last year, the federal appeals court had ruled that isolated DNA was patentable and that certain method claims were if directed to patentable subject matter, while certain method claims were not. The U.S. Supreme Court vacated this decision, however. It then ordered CAFC to reconsider the case in light of the Supreme Court’s ruling in the case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., the law firm said.


SEEKING TO BE THE MARKET LEADERS in testing for the human papillomavirus (HPV), Hologic, Inc., of Bedford, Massachusetts, completed its acquisition of Gen-Probe Inc., of San Diego, California.

Hologic paid $3.8 billion. Gen-Probe holds significant market share of testing for chlamydia, gonorrhea HIV, hepatitis B and hepatitis C. It is developing a test for HPV. Hologic already has an HPV test that it acquired when it paid $580 million to purchase Third Wave Technologies, of Madison, Wisconsin, in 2008.

HPV is the leading cause of cervical cancer worldwide and the market for cervical cancer screening is one of the biggest. In the United States alone, some 55 million cervical cancer screening tests are performed each year.


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