CombiMatrix Forms Molecular Dx Unit to Perform Home-Brew Tests; Eyes Eventual FDA Clearance
CombiMatrix has created a molecular diagnostics subsidiary, its parent company, Acacia Research, said this week.
The wholly owned subsidiary, named CombiMatrix Molecular Diagnostics, will focus on microarray-based diagnostics. Specifically, CMD will serve as a testing center for clinicians that wish to use CombiMatrix' array technology for certain molecular diagnostics applications, the company said.
The unit will initially focus on developing cancer diagnostics using the company's Desk Top Synthesizer, which enables researchers to build their own chips, according to Bret Undem, vice president of research at the Mulkiteo, Wash.-based company.
Company officials told BioArray News, a GenomeWeb News publication, that by setting up unit, CombiMatrix would take advantage of US Food and Drug Administration guidelines allowing homebrew microarrays in the creation of diagnostics, thereby generating revenue before its technology gets FDA approval. Under the FDA's home-brew rules, labs that make and test the diagnostic array in their facilities do not require clearance.
Undem said CMD will initially be a five-man operation based out of Irvine, Calif. It will be used to demonstrate the viability of CombiMatrix' products in molecular diagnostics, and to act as a specialized lab for clinicians who cannot get similar tests done by other third parties.
Quest to Develop Diagnostics Using SomaLogic Aptamer Tech; Invests $15M in Firm
Quest Diagnostics will develop new diagnostic tests based on SomaLogic's proprietary aptamer array platform, the companies said last week.
Terms of the deal call for Quest to make a $15 million equity investment in SomaLogic. Additional terms of the arrangement were not disclosed.
Applera and Roche Settle Litigation, Expand Licensing Program for PCR and Real-time PCR
Applera and Roche Diagnostics have settled their litigation over PCR technology and have included real-time PCR in their PCR licensing program, the companies said this week.
The firms have settled their litigation and arbitration about contractual relationships that involved rights to and commercialization of PCR and real-time PCR under undisclosed financial terms.
The companies' licensing program will now include patents for real-time PCR "and other important PCR-related technology," according company statements. Applera's ABI group will be the sole licensor of Roche patents covering methods and reagents for PCR and real-time PCR for life science research and other applications. Applera has also obtained a diagnostics license, with no right to sublicense, of Roche's nucleic acid technology patents.
In addition, Roche and Applera have granted each other licenses related to PCR technology for research and diagnostics. This includes the right for Roche to manufacture real-time PCR instruments for a third party under certain conditions.
Sequenom Reports 16-Percent Decline in Q1 Revenues, Narrowed Loss
Sequenom this week reported a 16-percent drop in revenues amidst narrowed losses for the first quarter of 2005.
Revenues for the quarter ended March 31 fell to $4.3 million from $5.1 million during the first quarter of 2004. Revenues were "impacted" this quarter by conditions Sequenom granted to new customers that enable it to recognize some revenues later this year.
"We believe that our MassArray products continue to gain traction in the clinical research market," with 130 systems installed so far, said acting-CEO and CFO Steve Zaniboni in a statement.
Research and development expenses fell to $3.2 million from $5.5 million during the same quarter last year.
Sequenom's net loss for the quarter narrowed to $7.4 million, or $.18 per share, from $9.9 million, or $.25 per share, during the year-ago period.
As of March 31, Sequenom had $31.4 million in cash, cash equivalents, short-term investments, and restricted cash.
Digene Licenses Luminex Platform Technology for Diagnostic Apps
Digene will have access to Luminex's bead-based xMAP multiplex technology together with non-exclusive worldwide rights to commercialize in vitro clinical diagnostic tests in women's health, as part of an agreement the companies announced last week.
Financial terms of the deal were not disclosed.