PerkinElmer, FDA Make Deal; Firm Resumes Selling Neonatal Dx Kits
PerkinElmer “has reached agreement” with the US Food and Drug Administration following the agency’s seizure of kits from its Norton, Ohio facility earlier this month, and will resume making and shipping neonatal diagnostic kits made in that facility, the company said late last week.
Under the agreement, which enables PerkinElmer to immediately restart producing and shipping the chemistry and isoelectric-focusing kits, the company will submit the products to additional undisclosed testing, and offer additional labeling advising proper use.
As SNPtech Pharmacogenomics Reporter wrote last week, the FDA on Feb. 5 had seized the PerkinElmer kits because they were “adulterated under the federal Food, Drug, and Cosmetic Act.” In the statement, the FDA said that the US District Court for the Northern District of Ohio had given it a warrant to seize the kits in PerkinElmer’s Norton facility, and that the US Marshal’s service had executed the warrant Feb. 4.
The FDA said at the time that the kits, which are used to screen for genetic diseases such as sickle cell anemia and multiple sclerosis, “were not manufactured in accordance with FDA’s good manufacturing practice quality system regulation.”
LabCorp Posts Strong Q4 Revenue, Profit Growth …
LabCorp last week posted a strong increase in fourth-quarter revenue amid slightly widened expenses and a jump in net earnings.
Total receipts for the period ended Dec. 31 increased to $731.5 million from $650.1 million one year ago.
LabCorp said it cost $430.8 million to run the company in the fourth quarter, which was around $34 million more than the firm spent in the same quarter in 2002.
Still, net earnings in the quarter grew to $77.6 million, or $.54 per share, from $53 million, or $,36 per share, year over year.
LabCorp said it had approximately $123 million in cash and equivalents as of Dec. 31.
… and Becomes First Customer of Third Wave’s Drug-Metabolism Assay
LabCorp has become an “early adopter” of Third Wave Technologies’ new Invader cytochrome P450 2D6 assay panel, Third Wave said last week. It is Third Wave’s first pharmacogenomics product, and LabCorp is its first customer.
LabCorp will use the assay, which is classified into four drug-metabolism categories, to help drug makers predict drug response in subjects.
The panel comprises SNPs, single and multiple base-pair deletions, and whole gene deletions and duplications in the 2D6 gene family.
Cepheid Issues Public Stock Offering Valued at $61.9 Million
Cepheid is offering 5.5 million shares of common stock at a public offering price of $11.25 per share, the company said last week. The total value of the offering is $61.9 million.
Cepheid also said it has granted its underwriters an option to purchase up to an additional 825,000 shares of common stock to cover over-allotments. UBS Securities is the sole book-running manager for the offering. William Blair & Company, C.E. Unterberg, Towbin, and Rodman & Renshaw are acting as co-managers.
In late January, Cepheid, in a preliminary fourth-quarter earnings report, said it expects revenues for the period ended Dec. 31 to have increased to $4.9 million from $3.7 million one year ago. Net loss was also expected to have increased to $4.5 million from $3.5 million in the year-ago quarter.
Genaissance Posts Q4 Revenue Surge; R&D and Net Loss Grows
Genaissance last week posted a strong jump in fourth-quarter revenues atop increased R&D spending and a widened net loss.
Receipts for the three-month period ended Dec. 31 surged to $4.7 million from $2.6 million one year ago. R&D spending, meantime, also increased in the fourth quarter to $6 million from $4.3 million in the year-ago period.
Net loss widened to $6.5 million, or $.28 per share, from $5.4 million, or $.24 per share, year over year, Genaissance said. The company said it had around $16.8 million in cash, cash equivalents, and marketable securities as of Dec. 31.
Galapagos Pockets €1.4 Million Grant for Alzheimer’s Research; Seeks Pharma Partner
Belgian functional genomics company Galapagos Genomics has won a €1.4 million ($1.8 million) grant from a national science institute to perform research into Alzheimer’s disease, the company said last week.
Specifically, Galapagos will use the money, awarded by the Flemish Institute for the Promotion of Industrial Scientific-Technological Research, to develop an undisclosed number of disease-relevant assays based on neuronal cells.
The company said it intends to use these assays with its adenoviral-based target-discovery platform. Galapagos said its goal is to work with pharma partners to develop any validated drug targets.
Galapagos currently has ongoing R&D collaborations with Bayer, Boehringer Ingelheim, and Proctor & Gamble.
TGEN Will Use Affymetrix Technology For Certain US Government Projects …
Arizona’s Translational Genomics Research Institute will use Affymetrix’s DNA analysis technology when it provides genotyping services to its collaborators and NIH-funded core facility programs, the companies said.
TGen, based in Phoenix, currently runs gene-expression core facility programs on the Affy platform for the National Institutes of Mental Health and the National Institutes of Neurological Disease and Stroke. As part of this exclusive agreement, those programs have been expanded to run the Affy DNA analysis technologies.
… As Silicon Genetics and Affy pen Deal to Tightly Integrate Software to GeneChip
Silicon Genetics and Affymetrix plan to more fully integrate Silicon Genetics’ software products for use on Affy’s GeneChip platform. The agreement advances a deal the firms penned in July that under which Silicon Genetics would distribute the GeneChip probe-level data directly.
Silicon Genetics makes the GeNet application for enterprise-wide management of microarray data at multi-centric organizations, and the GeneSpring product line for data analysis and visualization.
Lexicon Genetics Wins Additional US Patent for Gene Targeting
Lexicon Genetics has won a US patent that “broadly covers” a technology used in gene targeting for its gene-knockout technology, the company said this week.
U.S. Patent No. 6,689,610 comprises “a variety of methods” of selecting certain gene manipulations made by gene targeting, Lexicon said. It said the patent also covers methods called “positive- positive” selection.
Genomics Collaborative to Provide DNA Banking Services for Drug Maker Sention
Genomics Collaborative has signed a DNA and serum banking agreement with drug maker Sention, the companies said this week.
Terms of the agreement call for GCI to collect serum samples, isolate DNA, and manage the data for Sention.
Though the pharmaceutical company focuses on memory impairment and other central nervous system disorders, the GCI deal will support “an unspecified disease state,” the firms said.
DxS Licenses Scorpion to Swedish Molecular Dx Shop
Swedish molecular diagnostics company Sangtec has licensed from DxS its Scorpions genotyping technology, the companies said ths week.
Financial terms were not disclosed.
Scorpions is a fluorescence-based nucleic acid-detection and genotyping system. Sangtec is a fully owned subsidiary of Germany-based Altana Pharma.