A Diagnostics & Imaging Week

Clarient (Aliso Viejo, California) reported that it will sell its Automated Cellular Imaging System (ACIS) and Trestle Instruments Systems business assets and related intellectual property to Carl Zeiss MicroImaging (G ttingen, Germany) for $11 million in cash and up to an additional $1.5 million subject to satisfaction of certain post-closing conditions.

Clarient said the transaction completes its three-year “evolution” from an equipment sales model to a diagnostic services model.

Clarient and Carl Zeiss will each invest up to $3 million in cash or other in-kind contributions to pursue strategic joint development arrangements for novel markers and new menu applications for the ACIS product line.

Clarient said the growing demand for personalized medicine has generated a need for these novel diagnostics, creating a market expected to reach $1 billion in three to five years.

“The timing for this sale is ideal, and Zeiss is the perfect partner,” said Ron Andrews, president/CEO of Clarient. “We have diligently planned and executed Clarient’s transformation into a leading diagnostic services company. This transaction enables us to explore greater opportunities without the financial limitations that have restrained us in recent years. Additionally, we believe that our relationship with Zeiss will provide us access to the critical technologies that we need to develop novel markers, which will ultimately be used to monitor cancer and tailor individualized therapies.”

Clarient said it retains access to the intellectual property related to the image analysis and application development software. The agreement also includes a royalty-free cross-license to Clarient for certain of the transferred intellectual property to develop new tests and capabilities for Clarient’s laboratory services, including the ACIS platform. These activities will be done exclusively on Zeiss equipment and will support the continued development of Systems offered by Zeiss.

Andrews said, “This transaction significantly strengthens Clarient’s balance sheet and provides the financial flexibility for Clarient to reach break-even in cash flow from operations by year end and make key investments in technologies and tests . . . .”

Ulrich Simon, president/CEO of Carl Zeiss MicroImaging, and responsible for the global Microscopy business of Carl Zeiss, said, “With Clarient’s ACIS platform, Carl Zeiss MicroImaging acquires the gold standard for tissue based cancer diagnostics. This acquisition will complement Zeiss’ strong portfolio of micro-imaging technologies.” He added: “We are delighted that the agreement also contains arrangements for establishing a continued co-operation with Clarient’s innovative Lab Service Business in the field of rare event detection.”

Clarient was formed in 1996 to develop and market the ACIS technology, an advance in slide-based testing. It says that the “rise of individualized medicine” fueled expansion into broader diagnostic offerings “such as flow cytometry and molecular testing in-house.

Carl Zeiss MicroImaging offers microscopy solutions and systems for research, laboratories, routine and industrial applications, as well as spectral sensors for the analysis market.

In other dealmaking activity:

• Siemens Medical Solutions (SMS; Malvern, Pennsylvania) reported closing the acquisition of certain intellectual property rights and assets from BD (Becton, Dickinson and Company; Franklin Lakes, New Jersey) related to BD’s BD.id Patient Identification System for managing the specimen collection process. Financial terms were not disclosed.

SMS said the acquisition of the BD.id system represents “a milestone” for patient safety improvement and enhanced clinical workflow, and improvement in the specimen collection process. It added that this expands its “newly-established presence” in the in vitro diagnostics market, referring to its $5.3 billion acquisition of Bayer Diagnostics (Tarrytown, New York) completed in January and first disclosed last July.

SMS said that the BD.id system safeguards specimen collection and management by pairing software and bedside bar-coding technology. When a collection order is entered, it is downloaded to the system server and transmitted to a handheld computer with a bar-code scanner.

Before beginning a collection, the healthcare professional scans his or her identification badge and then scans the patient’s wristband. The handheld device then displays the specimen collection orders for that patient. After the specimens are collected, the labels are individually printed and applied to the scanned tube while still in the presence of the patient. The label contains patient demographic information, the name of the healthcare professional who collected the specimen, the test and the container type, as well as the date and exact time of collection.

The system is designed to streamline and reduce errors in the collection of blood, urine or other samples by helping to confirm that the correct specimen is collected from the right patient.

The purchased system “allows for both of these recommendations to be achieved,” SMS said.

Janet Dillione, president, Health Services, SMS Healthcare Information Technology Division, the patient identification system from BD, said, “together with Siemens’ Med Administration Check, provides Siemens customers with an additional point-of-care technology to further the goal of connecting positive patient identifiers to everything that is given to or taken from a patient at the bedside.”

• MacroArray Technologies (Philadelphia) said it has signed a licensing agreement with Abbott Laboratories (Abbott Park, Illinois) for MacroArray’s antibody test for prostate cancer. Terms were not disclosed.

As part of the agreement, Abbott will develop and market the PCADM-1 test, an assay to detect the PCADM-1 prostate specific protein in urine.

The PCADM-1 gene is characterized as a mutated form of the S2 gene and studies have demonstrated the PCADM-1 gene to be over-expressed only in malignant prostate tissue. In blinded studies of 533 patients, results indicated the test has an average sensitivity of 79%, and a specificity of 73% to 100%. The test may offer advantages over prostate specific antigen (PSA) testing, the current standard for initial prostate cancer screening in conjunction with a digital rectal exam (DRE).

MacroArray makes technology designed to identify and develop diagnostic markers for the early detection and staging of cancer and linking these diagnostic tests to therapeutic monitoring and efficacy.

• CardioNet (San Diego) a provider of wireless mobile cardiac outpatient monitoring solutions, said it completed its previously disclosed acquisition of PDSHeart (West Palm Beach, Florida), a cardiac event monitoring company. Terms were not disclosed.

PDSHeart will operate as a CardioNet subsidiary, with corporate offices in West Palm Beach, Florida. The combined company has monitoring centers in Pennsylvania, Minnesota, Florida and Georgia.

• Lifeline Biotechnologies (Reno, Nevada) reported that the company has reached an agreement with Solos Endoscopy (Boston) to reacquire ownership, including all rights, to continue the development and marketing of the First Warning System, designed to assist in early detection of breast cancer.

Lifeline’s technologies focus on prevention, early detection, diagnosis and quick recovery of a number of disease conditions.