A Diagnostics & Imaging Week

Exact Sciences (Marlborough, Massachusetts) reported it has an expanded agreement with Laboratory Corporation of America Holdings (LabCorp Burlington, North Carolina) that allows for broader distribution of Exact’s DNA technology of colorectal cancer (CRC) screening.

Exact now agreed to extend LabCorp’s exclusivity period through 2010 in exchange for other terms including Exact’s right to also license the technology to select organizations and other commercial service laboratories.

Prior to this amendment with LabCorp, Exact was eligible to receive up to $45 million in payments from LabCorp related to certain objectives including $30 million relating to the achievement of sales targets, and $15 million related to policy-level reimbursement approval from key payors including Medicare and inclusion of stool-based DNA screening in clinical practice guidelines.

In the agreement, $40 million in potential milestone payments remain, all of which are now payable to Exact upon achievement of significant sales thresholds.

In exchange for the extended exclusivity, LabCorp also gave up any rights it had to receive about $3 million from Exact in connection with certain historical third-party royalty amounts.

Under the terms of the agreement, Exact will potentially be obligated to reimburse LabCorp for certain third-party royalties, up to a maximum of $1 million annually.

The amended agreement also provides that LabCorp will pay Exact a 15% royalty on LabCorp’s net revenues from PreGen-Plus, an amount that could increase to 17% if annual net revenues exceed a specified threshold. LabCorp also retains preferential pricing terms as compared to third parties to whom Exact may license its stool-based DNA screening technology.

“We are very committed to our partnership with Exact and have taken steps to enable even broader distribution for PreGen-Plus,” said David King, president/CEO of LabCorp. “This extended exclusivity, with provisions for LabCorp to allow additional labs to distribute the technology, will facilitate further market penetration for the assay. It also provides expanded testing opportunities for what we hope will be a positive decision by the American Cancer Society [Atlanta] and the U.S. Multi-Society Task Force to include stool-based DNA (sDNA) in the updated CRC screening guidelines.”

Exact uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. LabCorp is a clinical laboratory with annual revenues of 3.6 billion in 2006.

In other agreements:

• Research Corporation Technologies (RCT; Tucson, Arizona) has granted Royal Philips Electronics (Amsterdam, the Netherlands) and its affiliates, including the ultrasound business of Philips Medical Systems (Best, the Netherlands), a nonexclusive license to pioneering patents owned by RCT that broadly cover ultrasound tissue harmonic imaging (THI).

RCT manages the THI technology for its partner, the University of Rochester (Rochester, New York). Seminal work in the early 1990s by Ted Christopher, PhD, at the university’s Center for Biomedical Ultrasound resulted in a new mode of ultrasound imaging that has become an essential part of diagnostic ultrasound today, according to RCT. Christopher’s invention showed that the second and higher-order harmonic response of native tissue to a propagated ultrasound beam could be employed to produce a sharper, better-contrast image than that of the fundamental emitted frequency, the company said.

Royal Philips Electronics of the Netherlands employs roughly 124,300 employees in more than 60 countries worldwide.

Philips joins Acuson, a Siemens (Munich, Germany) company, as a licensee of the tissue harmonic imaging technology. RCT continues its efforts to license the technology broadly to the ultrasound industry.

RCT is a technology investment and management company that provides early-stage funding and development for promising biomedical companies and technologies from universities and research institutions worldwide.

• Sysmex (Kobe, Japan) reported Monday an agreement with bioMerieux (BIM; Paris) to distribute Sysmex’s UF-100i urinalysis system in microbiology laboratories.

Sysmex has developed the fluorescence flow cytometry UF-1000i urinalysis system, a highly standardized and automated solution. BIM will provide its extensive customer base with this new technology and leverage its expertise and reputation in microbiology to expand the market. Commercialization by BIM will start in Europe in September 2007 and be followed by the U.S. and other countries at the beginning of 2008.

“The collaboration with bioM rieux will allow us to leverage our proven technology of particle analysis to tap into a new market segment and fuel further growth of our core business,” said Hisashi Ietsugu, president of Sysmex. ”This agreement complements our existing partnerships for distributing the UF instrument series for use in other IVD segments.”

Sysmex is involved in clinical laboratory testing of blood, urine and other specimens. BIM provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety.