Agendia, Agilent to Develop Dx Tests, Extend Supply Pact
Agendia and Agilent Technologies announced this week that they have extended a supply agreement and intend to collaborate on the development of new in vitro diagnostic tests.
According to a joint statement, the firms will collaborate on developing cancer diagnostic tests that will be run on Agilent microarrays.
In February 2007, Amsterdam, Netherlands-based Agendia received US Food and Drug Administration clearance for its MammaPrint diagnostic for breast cancer recurrence. The test, which is performed on an Agilent microarray, was the first in vitro diagnostic multivariate index assay device approved by the FDA since the agency released a draft guidance in 2006 describing such products (see BAN 2/13/2007).
The partners also announced that Agendia’s products will continue to be supplied on Agilent microarrays through Dec. 31, 2011. Agilent has been manufacturing the components for the Agendia assay since 2003, the firms said.
"We eagerly anticipate expanding our role beyond the manufacturing of Agendia products on the Agilent microarrays to helping them build validated diagnostic cancer tests, as well as developing and expanding the company's worldwide distribution channels,” Yvonne Linney, vice president and general manager of genomics for Santa Clara, Calif.-based Agilent, said in the statement.
Financial terms of the agreements were not disclosed.
Fluidigm Looks to Raise up to $86.25M in IPO
Fluidigm last week filed with the US Securities and Exchange Commission for an initial public offering of common stock.
The South San Francisco, Calif.-based firm did not disclose how many shares it intends to offer, and the preliminary prospectus did not provide an estimated range for the offering’s share price. However, it noted that the proposed maximum amount it intends to raise is $86.25 million.
Fluidigm makes integrated fluidic circuit systems for performing life science experiments in parallel on a single chip. One of its fluidic systems, the BioMark, is used for gene expression analysis, genotyping, and digital PCR, while another, the Topaz system, is used for protein crystallization research.
For the year ended Dec. 29, 2007, Fluidigm had revenues of $7.3 million and a net loss of $25.5 million, or $2.63 per share. As of that date, it had $40.4 million in cash, cash equivalents, and available-for-sale securities, according to the filing. Its total accumulated deficit from inception through the end of 2007 was $133.8 million.
Among the risk factors cited by Fluidigm in its prospectus is that the sales cycle for its products is “lengthy and unpredictable, which makes it difficult for us to forecast revenue and could cause significant quarterly fluctuations in revenue and other operating results.” The firm also noted that it receives a substantial portion of its revenues from a limited number of customers.
The firm intends to float on the Nasdaq market under the symbol “FLDM,” and anticipates having roughly 66.6 million shares outstanding following the IPO.
Morgan Stanley is the book-running manager for the offering, with UBS and Leerink Swann acting as co-managers.
Fluidigm did not respond to additional questions about the IPO by press time.
Nonprofit Group Offers Guidelines for Multiplex Assays
Citing the rapid recent growth in the number of multiplex assays making their way to market, a nonprofit medical testing group with industry ties has drawn up a set of recommendations for lab practices and controls.
The Clinical and Laboratory Standards Institute’s recommendation, “Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline," offers guidelines for analytic verification and validation of multiplex assays and a review of biologic and synthetic reference materials.
The recommendations cover sample preparation; reference quality control materials; analytic verification and validation; data analysis; and reporting results. It also offers a discussion of multiplex methods and technologies.
The goal of the guide, which costs $120 for non-CLSI members and $60 for members, is to help labs and manufacturers in the development, verification, validation, and implementation of multiplex nucleic acid tests for diagnostic purposes.
“Almost all of the new clinical tests are based on multiplexing of analytes, and there is currently no other reference available for this purpose,” Jean Amos Wilson, a CLSI committee co-chair and senior director of Sequenom’s Genetic Services Lab, said in a statement.
The paper also contains an overview of current technologies, as well as a review of the designs and uses of control materials such as blood samples, residual patient samples, products of whole genome amplification, synthetic oligonucleotide simplex and multiplex controls, and plasmids. The authors also illustrate proper verification and validation protocols using current assay formats and appropriate data analysis and results reporting.
The report is available here.
Xceed Partners with UFL on Gene Signatures for Bladder Cancer
Xceed Molecular, a developer of gene expression analysis systems, said last week that it will work with scientists at the University of Florida in a collaboration aimed at developing a gene expression signature for differentiating early-stage bladder cancer from other conditions.
Through the company’s Strategic Collaborator Program, UF researchers Charles Joel Rosser and Steve Goodison, in the school’s Urology and Surgery departments, respectively, will perform initial verification and validation of a signature that could be used to differentiate the cancer from other conditions using urine samples.
The collaborators will test around 700 samples from patients previously identified to have either cancerous or non-cancerous bladder tumors in order to verify that the gene expression signature can be used to distinguish the two groups.
Xceed will run the first 100 samples on its Ziplex System in its Toronto labs. Xceed also will provide the university with a Ziplex System, which it will use to study the rest of the samples. If the collaboration validates the signature, Xceed and the university will pursue more clinical testing to validate the signature for use in managing patients.
Financial terms of the agreement were not released.
World Microarray Congress to Take Place in June
The fourth annual World Microarray Congress will be held June 28 and 29 in Vancouver, Canada, organizers told BioArray News last week.
The meeting will focus on key microtechnology issues affecting both academic array users and also pharmaceutical and biotech users. Seminar topics will include microarray technology in medicine, biomarker discovery, data analysis, future directions of genomic research, proteomic technologies, applications for drug discovery, and platform comparisons.
Additional information is available here.
South Africa’s CPGR Officially Opens Doors
The Center for Proteomic and Genomic Research officially opened its doors to South Africa’s biotech community on April 3, according to co-director Reinhard Hiller.
The Capetown-based center was founded in 2006 with $3 million grant from Cape Biotech Trust and PlantBio, two state-funded South African biotechnology development initiatives.
Mosubudi Mangena, the South African Minister for Science and Technology, said in a statement that CPGR will “play a role in easing the burden of disease by enabling South African scientists to develop improved medical diagnostics, attain a greater understanding of relevant diseases in our society, as well as mine Southern African biodiversity to generate new medicines from the local flora and fauna.”
BioArray News spoke with Hiller about CPGR’s endeavors in February (see BAN 2/19/2008).