FDA’s Clinical Pharmacology Subcommittee Will Discuss Pharmacogenetics on April 23
A US Food and Drug Administration subcommittee on April 23 will discuss ways to use pharmacogenetics to improve existing drug treatments, the regulatory agency said last week.
The Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science in the past has advocated using genetic testing to determine appropriate dosing for certain drugs.
At a meeting on Oct. 22, for example, the subcommittee suggested that labeling for GlaxoSmithKline’s drug Purinethol should recommend pharmacogenetic testing in order to guide dosing. Supporting its position, the group presented data about patients with certain enzyme deficiencies that are said to adversely affect the drug’s clearance.
Isis to Use Sequenom MassArray in Antisense-Based Drug Discovery
Sequenom and Isis Pharmaceuticals have partnered to discover potential SNPs within Isis’ antisense drug targets, the companies said this week.
Using antisense oligonucleotide binding regions on mRNA targets identified through the pharma company’s internal research programs, Sequenom will use its re-sequencing technology together with its library of DNA samples to find naturally occurring variations within the target regions in the general population.
The project, which is a novel use for Sequenom’s MassArray technology, will help Isis “eliminate antisense candidate regions that contain common genetic variation, allowing us to focus ... on target regions likely to be successful in a diverse patient population,” said Frank Bennett, Isis’ vice president of antisense research.
Paradigm Genetics embraces Microarray Services; Pens marketing Deal with Agilent
Paradigm Genetics last week tossed its hat into the microarray processing ring when it announced a co-marketing agreement with Agilent Technologies.
Under the agreement, Paradigm will become a preferred service provider for Agilent’s microarray products. The agreement follows on the heels of a multi-year supply deal already in place with Agilent. In this deal, Agilent, the No. 2 manufacturer of microarrays, services Paradigm’s five-year, $23.8 million toxicogenomics contract with the National Institute of Environmental Health Sciences.
Friz Biochem Raises $3 Million to Develop DNA Microarray Platform
German microarray developer Friz Biochem has raised €3 million in the first closing of a Series B round of private-equity financing, the company said last week.
Existing shareholder Global Life Science Ventures led the round, which was joined by DRF Beteiligungsgesellschaft.
Munich-based Friz expects to raise additional funds, including soft loans, in a second closing, it said.
Friz develops a DNA microarray platform with an electrical readout technology. It plans to use the funding to establish pilot production capabilities and to validate the arrays in the areas of food pathogens and clinical diagnosis.
Affymetrix, Axon to Co-develop Tool to Scan New Family of GeneChip Arrays
Axon Instruments and Affymetrix last week said they intend to co-develop an instrument to scan a future generation of GeneChip microarrays.
Based on Axon’s ImageXpress automated cellular screening platform, the new instrument will scan GeneChip arrays formatted in multi-well plates — a high-throughput array solution currently in early development at Affymetrix Research Laboratories. Axon’s ImageXpress technology will also enable four-color scanning of GeneChip microarrays and array plates.
US Court Prohibits LAB21 from Using Knowledge from GeneLink Agreement
GeneLink last week said that a US District Court entered a preliminary injunction prohibiting LAB21 from using “any confidential information” it may have learned during a collaborative effort to test market a DNA face cream based on GeneLink’s SNP-profiling methodology.
The District Court for the District of New Jersey also upheld a contract provision that prevents LAB21 from using SNP technology to make its skin care products.
Aclara, Amersham Biosciences Pen Marketing Collaboration
Aclara BioSciences and Amersham Biosciences signed a non-exclusive agreement that marries as complementary systems Amersham’s MegaBace DNA analysis system and Alcara’s eTag assay system. The firms will continue to sell and support the systems independently, but will promote the other's products for their respective platforms.
Nasdaq Grants Orchid Stay of Delisting; Firm Secures $16m in Private Placement
Nasdaq allowed Orchid Biosciences to continue listing on its exchange until June 24, the company said last week.
Orchid received a delisting warning notice from Nasdaq Jan. 3 after its stock traded below $1 for more than 120 days. Orchid appealed to exchange, and a hearing before a listing-qualifications panel was held in February.
This is the third dose of good news for the struggling forensics and pharmacogenetics firm: Two weeks ago, Orchid Biosciences received a waiver from the Nasdaq allowing it to bypass shareholder approval and forge ahead with a private-financing plan it hopes will generate $16 million. Orchid closed the financing this week with BayStar Capital, SDS Capital Partners, and other institutional investors.
The company is also seeking shareholder approval for a reverse stock split at a special shareholder meeting scheduled for April 15.
Nasdaq granted the exception on the grounds that securing shareholder approval might seriously jeopardize the financial viability of the company, Orchid said. This week, the company was able to sell 1,600 shares of newly-issued convertible preferred stock, with each share convertible into approximately 22,222 shares of common stock.
Pyrosequencing, Thomas Jefferson University Pen IBD Genotyping Deal
Thomas Jefferson University has bought a PSQ HS 96A genotyping system from Pyrosequencing as part of a collaborative agreement to analyze genes and develop applications for inflammatory bowel disease, the company said this week.
The university will use the system to study SNPs in genes related to IBD. Ultimately, it plans to develop a gene-based diagnostic tool.