“This mass spectrometer will enable us to identify previously unknown biomarkers, that is, characteristics that can be objectively measured biochemically as indicators of pathogenic processes,“ Christiane Auray-Blais, scientific director of the Waters-CHUS center, said in a statement. “This will enable us to better understand certain diseases, such as Fabry disease, establish correlations with the severity of the disorder, screen patients earlier, offer more effective treatment, and deliver better management.”
ABI, Invitrogen, Fluorotechnics, Labcorp, FDA, Thermo Fisher Scientific, Bruker PerkinElmer, Vermillion, Quest Diagnostics, National Center for Toxicological Research, Genedata, Geneva Bioinformatics, Proxeon, University of Florida, Ariadne, Waters
ABI, Invitrogen Shareholders Approve Merger
Shareholders from Applied Biosystems and Invitrogen this week approved the $6.7 billion merger of the two companies.
In separate statements, the two companies each said that more than 98 percent of the votes cast supported the merger. The total number of votes cast for each company represented more than 80 percent of the total shares outstanding and entitled to vote at special meetings held this week by each company related to the merger.
The deal is still subject to approval by European regulators which is expected to occur next month. If approved, the merger will close shortly afterward.
Fluorotechnics Completes IPO
Australian fluorescence and electrophoresis firm Fluorotechnics last week reported it has completed its initial public offering, raising nearly A$8 million ($5.5 million), surpassing the minimum A$6 million it had set but short of the A$12million maximum it had subscribed.
The company said it expects to list on the Australian Stock Exchange by Oct. 31 with more than 24 million shares on issue and a market capitalization of more than $24 million at $1 per share.
“Succeeding in a float in this market demonstrates the prospects of the company, as only a very robust investment proposition attracts new capital in these times,” said Fluorotechnics CEO Duncan Veal in a statement.
The company filed for its IPO last month [See PM 09/18/08]. Fluorotechnics will acquire the Gel Company, a purchase that was contingent on the completion of the IPO.
Fluorotechnics’ technology is based on a fluorophore called epicocconone which it says advantages over traditional color and radioactive labels including sensitivity, a wider dynamic range and non-toxicity.
LabCorp Discontinues Ovasure Ovarian Cancer Test
Responding to a recent warning letter from the US Food and Drug Administration regarding alleged “misbranding” of its OvaSure test, Laboratory Corporation of America said this week that it will discontinue offering the test and seek a meeting with the agency.
The clinical lab firm said in a letter sent to FDA last week that it disagrees with the agency’s assertion that the OvaSure test, which is a biomarker-based multiplex immunoassay, is a medical device that is subject to regulation under the Federal Food, Drug, and Cosmetic Act. "The OvaSure test meets all applicable CLIA regulatory requirements," LabCorp said in the letter sent to Steven Gutman, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.
It also said that it does not agree with the FDA that its alliance with Yale University, which performed earlier development work and licensed the technology to LabCorp, provides the agency with “any basis for exercising jurisdiction over the test.”
The FDA’s Sept. 29 warning letter to LabCorp said that the OvaSure test was “designed, developed, and validated by investigators at Yale University and not LabCorp.”
Particularly, the FDA said that its investigation had found that the instructions for use and the performance characteristics for the test were developed by Yale investigators. Furthermore, the agency found that certain materials associated with the tests were manufactured by another entity.
But LabCorp disputes FDA’s claims, stating in its letter, “LabCorp has licensed intellectual property from Yale University; we did not purchase any products or materials from Yale.”
The letter, which was signed by LabCorp SVP and General Counsel F. Samuel Eberts, added, “Yale has no control, contractual or otherwise, to influence the development, methodology, validation, performance characteristics, use, distribution or any other aspects of LabCorp’s testing service.”
LabCorp noted that its arrangement with Yale is similar to many others between academic research centers and clinical laboratories. “We are also unaware of any basis — and the Warning Letter cites none — for asserting that a laboratory assay is a device under the FDC Act because the laboratory allegedly did not establish the specifications for materials that the laboratory purchased from a third party vendor,” Eberts stated in the letter.
LabCorp said that it is “deeply concerned that the unprecedented position” taken by FDA regarding its relationship with Yale and the marketing of the OvaSure test “will stifle the ability of laboratories to provide innovative diagnostic tests.”
The firm said that even though it would discontinue offering the test as of Oct. 24, it requests a meeting with FDA officials to discuss its testing service and associated regulatory issues.
Industry observers have pointed out that FDA’s actions against LabCorp regarding OvaSure may further confound the agency's regulatory stance on IVDMIAs, particularly since the agency has yet to issue a final guidance on the matter. The final guidance is expected to be issued by FDA very soon.
Thermo Fisher, Queens University Research Group Collaborate on Peptide Drugs
Thermo Fisher Scientific this week said it has entered into a collaboration with the Molecular Therapeutics Research Group at Queen’s University Belfast’s School of Pharmacy.
Researchers at the university will use Thermo Fisher’s LTQ Orbitrap XL mass spectrometer on a trial basis to analyze peptides within amphibian venom for the purposes of drug discovery, the company said in a statement. Chris Shaw, who specializes in peptide drug discovery, will head the research.
No financial details were disclosed.
Bruker Q3 Revs Flat Amid Higher Spending, Customer Purchase Fluctuations
Bruker this week reported nearly flat third-quarter revenue growth and a decrease in profits, due to higher spending and expected quarterly fluctuations in purchases by customers.
The company had receipts of $242.1 million for the three-month period ended Sept. 30, nearly flat with revenues of $241.8 million in the third quarter of 2007. Excluding currency benefits, Bruker's revenues fell 7 percent year over year.
“Since our February 2008 merger [with affiliated firm Bruker BioSpin] we have experienced significant quarterly fluctuations,” Bruker President and CEO Frank Laukien said in a statement. “As in previous years, we expect strong revenues in our fourth quarter of 2008, as our bookings and backlog have remained healthy.”
Bruker's third-quarter profits declined 33 percent to $17.8 million for the quarter from $26.7 million a year ago.
The firm's R&D expenses rose 23 percent $33.1 million from $26.8 million.
Laukien noted that beginning this past summer the firm began taking steps to reduce its operating and interest expense and reduce its exposure to currency fluctuations. “We expect that our cost-cutting initiatives will already have noticeable positive effects in the fourth quarter of 2008 and first quarter of 2009, and that by the middle of 2009 we will see annualized reductions in our overall costs of greater than $12 million,” said Laukien.
Bruker finished the quarter with $87.4 million in cash and short-term investments.
PerkinElmer Life Sciences Up Almost 17 Percent in Q3
PerkinElmer last week reported a 16.9-percent hike in sales in its Life and Analytical Sciences division leading to an overall sales increase of 15.9 percent during the third quarter.
For the three months ended Sept. 28, the company said total sales had reached $505.1 million, up from $435.7 million a year ago. Sales in Life and Analytical Sciences rose to $373.4 million from $319.3 million during the year ago period.
PerkinElmer’s Optoelectronics division saw sales increase13.2 percent to $131.7 million from $116.3 million a year ago.
Net income jumped 68.8 percent during the quarter to $51.9 million, compared to $30.7 million a year ago.
Spending on research and development was $27.5 million. As of Sept. 28, the company had $188.8 million in cash and cash equivalents.
Vermillion, Quest Renew Agreement for Ovarian, PAD Tests
Vermillion this week said it and Quest Diagnostics have extended their strategic alliance agreement to develop and commercialize tests for ovarian cancer and peripheral artery disease through Oct. 29, 2009.
Vermillion has filed its OVA1 test for women with ovarian tumors that are at high risk of being malignant with the US Food and Drug Administration for 510(k) premarket approval. It said in a statement it has been in discussions with the agency about the submission and “is encouraged by the constructive nature of these discussions,” adding it expects to provide additional information and data to the FDA this quarter in order to address questions the agency has.
The Vasclir test is for the diagnosis of patients at high risk for PAD.
FDA’s National Center for Toxicological Research Renews Use of Genedata Expressionist
The US Food and Drug Administration’s National Center for Toxicological Research has renewed its agreement with Genedata for use of the company’s Expressionist biomarker discovery platform.
Weida Tong, director of the Center for Toxicoinformatics at the FDA said that it has successfully applied the platform in a number of projects including the Critical Path and the Liver Toxicity knowledgebase projects.
Expressionist is a modular computational platform for biomarker discovery that integrates proteomics, transcriptomics, and metabolomics data within a single enterprise software system.
Financial details were not disclosed.
Geneva Bioinformatics, Proxeon Ink Distribution Deal
Geneva Bioinformatics and Proxeon have inked an integration and distribution agreement for their respective proteomics and informatics platforms, GeneBio said this week.
Under the agreement, the companies will integrate GeneBio’s Phenyx protein identification platform with Proxeon’s ProteinCenter data interpretation software. Financial terms of the agreement were not disclosed.
The company said the combined offering will enhance efficiency and effectiveness for researchers analyzing mass spectrometry data. Users will link directly between Phenyx identifications to ProteinCenter and specific Phenyx Exports loaded into ProteinCenter, the company said.
The Proxeon software is based on a consolidated protein sequence database that enables filtering, protein grouping, and statistical bioinformatics analysis of single, combined, or comparison search results, GeneBio said.
U. of Florida Renews License for Ariadne’s Pathway Studio
Ariadne this week announced the University of Florida has renewed its site license for Pathway Studio. The university is using the software for medical and agricultural-related proteomics and gene-related studies.
No financial details were disclosed.
The license is available to all UF scientists via ICBR Bioinformatics core. Pathway Studio streamlines hypothesis generation “by creating visual interactive networks of biological relationships extracted from scientific literature and reference data sources,” Ariadne said in a statement.
Waters Donates Synapt to Quebec Center
Waters said this week it has donated a Synapt MS System to a Quebec-based research center for screening, clinical diagnosis, and assessment of treatments for specific hereditary diseases.
The mass spec system was donated to the Foundation du centre hospitalier universitaire de Sherbrooke and will be used by the Waters-CHUS Expertise Center for Clinical Mass Spectrometry, a collaboration between the hospital and Waters. Waters said that the gift was worth around C$1.1 million (US$893,000).