In its $185 million acquisition of a portion of Focus Diagnostics last week, Quest Diagnostics has gained access to the company's broad array of molecular assays and services, including diagnostics Focus has been working on with Stratagene and its FullVelocity platform.
As part of the deal, which the firms expect to close during the third quarter, Quest inherited an agreement Focus signed with Stratagene in December in which Focus was to develop and market FullVelocity real-time PCR-based products as in vitro diagnostics worldwide for certain undisclosed indications. Stratagene agreed to manufacture and supply products for Focus to commercialize, as well as to make reagents for Focus' national reference laboratory to use for those tests.
"We believe that our opportunity with Focus is sound," Steve Martin, Stratagene's CFO, said through a company spokesperson this week. The company declined to say anything more about the acquisition's impact on Stratagene's agreement with Focus.
Currently, Focus offers five gene-based tests, of which the first batch — for hepatitis C viral load, hepatitis B viral load, and cystic fibrosis — was added to the company's menu in March. The CF diagnostic, along with a CF carrier screen and an Ashkenazi Jewish carrier screen, are based on Tm Bioscience's Tag-It technology, while the hepatitis tests are based on Applied Biosystems' TaqMan technology.
"We believe that our opportunity with Focus is sound" with Quest.
The diagnostics that Focus and Stratagene had been developing were related to undisclosed applications in infectious disease, with the ultimate goal of producing in vitro devices cleared by the US Food and Drug Administration. Neither company has offered a timeline for device launches or regulatory clearance. In addition to infectious diseases, Stratagene said FullVelocity is suited to diagnostics in drug-sensitivity assays, cancer, and genetic diseases.
The Focus agreement was the first of what Stratagene hopes will become a string of similar partnerships resulting in new molecular diagnostics. "The intent is to develop, obtain [FDA] approval, and commercialize … diagnostic test kits," Martin told Pharmacogenomics Reporter sister publication BioCommerce Week in December.
Stratagene has not announced any specific IVD plans for FullVelocity since then, but it said in March that it had agreed to develop customized software and system features for its Mx3005P QPCR platform for Bayer HealthCare. Bayer planned to use the instruments as components of its modular Q-PCR systems to expand its own IVD offerings.
The original deal between Focus and Stratagene also happens to be the first agreement involving FullVelocity after a suit filed by Third Wave in September 2004 found that certain FullVelocity patents infringe Third Wave's IP. "The embodiment of FullVelocity that will be used in relationship with Focus does not infringe with Third Wave patents," Stratagene spokesperson Steve DiMattia told Pharmacogenomics Reporter in December.
Focus Diagnostics boasts that it offers more than 1,200 infectious disease laboratory tests. The company also says it develops internally or through collaborations or in-licensing more than 50 new or improved lab assays and three to five new diagnostic products each year.
Before its acquisition by Quest, Focus was composed of two main divisions, Healthcare Diagnostics and Pharmaceutical Diagnostics. Healthcare Diagnostics, which Quest is acquiring, is further divided into reference laboratory services and a diagnostic products unit. The rest of Focus — the Pharmaceutical Diagnostics division — is going to continue as a private contract research organization by the name of Focus Bio-Inova.
The company changed its name from Focus Technologies to Focus Diagnostics in December 2004. Focus Bio-Inova — the Pharmaceutical Division — took that name when Focus Technologies acquired France-based Inova in late 2003, adding immunology, oncology, metabolic-, and cardiovascular-disease specialties to the existing focus in infectious disease.
— Chris Womack ([email protected])