Osmetech Receives 510 (k) Clearance for CF Assay
Osmetech Molecular Diagnostics has received 510 (k) clearance from the US Food and Drug Administration for a cystic fibrosis carrier detection assay that runs on its eSensor Detection System, according to a company official.
The approval appears to make Osmetech the third company to bring an array-based IVD through the regulatory process (see BAN 1/3/2006).
Bruce Huebner, president of OMD, told BioArray News as this issue was being finalized that the firm is "very pleased" with the approval and believes it will "open up doors" for the company as Osmetech continues to look to develop content with other partners that would be interested in the platform.
The eSensor system includes the eSensor 4800 reader, which uses electrochemical detection to register results from a customizable single-use eSensor biochip disposable cartridge. Osmetech is also planning to submit a cytochrome P450 assay for FDA approval in the future (see BAN 11/30/2005).
UC Davis Joins CombiMatrix's Core Access Program
The University of California, Davis, has joined CombiMatrix's CombiCore access program, Combi parent Acacia Research said this week.
Under the non-exclusive agreement, all UC Davis researchers can purchase, through the UC Davis Genome Center, CombiMatrix's CustomArrays and CatalogArrays, including array processing services performed at the UC Davis Genome Center.
Financial details were not disclosed.
This is the second university CombiMatrix has signed on to its CombiCore program, which the company initiated this quarter. Earlier this month it signed an agreement with the University of Colorado (see BAN 1/10/2006).
Orion Genomics, Univ. of Glasgow Pen Biomarker-Discovery Alliance for Cancer
Scientists at Orion Genomics and the University of Glasgow will try to identify epigenetic biomarkers for developing early cancer screening and personalized therapy options, Orion said last week.
Under the agreement, scientists will use Orion's methylation technologies to identify biomarkers that can be used to detect and treat cancers of the lung, breast, and ovaries.
Orion said that the research will utilize its MethylScope microarrays and MethylScreen PCR assays to compare patterns of DNA methylation from normal and tumor DNA to identify specific patterns of abnormal methylation. The company said it will also develop diagnostics based on these patterns that detect trace amounts of methylated tumor DNA.
GE Healthcare Q4 Revenues Up 5.4 Percent;
Agrees to Bundling Deal with Alpha Innotech
General Electric last week reported that revenues for its healthcare segment increased by 5.4 percent for the fourth quarter of 2005, to $4.49 billion from $4.26 billion during the fourth quarter of 2004.
GE reported total earnings of $18.3 billion for 2005, up 12 percent from $16.3 billion in 2004. Earnings per share were $1.72, up 10 percent from 2004.
The company did not disclose its research and development spending for the fourth quarter of 2005.
Separately, GE said last week that it is partnering with Alpha Innotech to bundle its ArrayVision microarray analysis software with Alpha Innotech's NovaRay multiplex array reader.
Further details of the deal were not disclosed.
Nanogen and Princeton Biomeditech to Develop Heart Failure IVD
Nanogen has signed a manufacturing and distribution agreement with Princeton Biomeditech to develop a point-of-care in vitro diagnostic assay that detects NT-proBNP, a marker of heart failure, Nanogen said last week in documents filed with the US Securities and Exchange Commission.
According to the terms of the agreement, Nanogen will develop reagents that PBM will incorporate into a final product. Nanogen will be responsible for clinical trials necessary for regulatory approval. PBM will develop a reader for the test, half of whose development will be funded by Nanogen, and the company will seek regulatory approval for the device as well.
PBM will have the right to a nonexclusive license or supply aggreement for Nanogen reagents for detecting biomarkers related to congestive heart failure, stroke, or traumatic brain injury. PBM will manufacture the test and its reader, and it gains limited distribution rights.
Agilent to Restate 2004 Financials; Net Income Increased $20M
Agilent last week said that it would restate its 2004 financial results due to an accounting error. The restatement decreases the firm's provision for income taxes for fiscal 2004 and the quarter ended Oct. 31, 2004, by $20 million, and increases the firm's net income by $20 million, or $.04 per diluted share.
The company said that it miscalculated or understated its estimate of US jurisdictional loss during the preparation of its financial statements for fiscal 2004. Agilent said the error was identified through its internal control over financing during 2005, and it has included the restatement in its annual report and form 10-K for fiscal 2005, which was filed this week.
For its 2004 fiscal year, which ended Oct. 31 of that year, Agilent had reported fiscal fourth-quarter 2004 revenue of $1.8 billion, a 9-percent gain over revenue of $1.7 billion in the fourth quarter of 2003. Agilent's fourth-quarter net income increased to $74 million, or $.15 per share, from $13 million, or $.03 per share, year over year.
For its fiscal year ended Oct. 31, 2004, Agilent had reported revenue of $7.2 billion, compared to $6.1 billion in fiscal 2003. Net income increased to $349 million, or $.72 per share, compared to a loss of $2 billion, or $4.35 per share, in fiscal 2003.
SciGene Sells Array System to Stanford's Brown Lab
SciGene said last week that it has installed a BriteSpot Microarray Workstation at Pat Brown's lab at Stanford University.
The company said that the sale marks the first installation of the system, which automates microarray hybridization, washing, and drying in an ozone-safe environment.
SciGene said that the BriteSpot system was developed through in collaboration with Brown Lab scientists.
Financial details were not disclosed.