California Sends Warning Letter to Consumer Genetic Testing Firms
The State of California is trying keep consumer genetic testing companies from offering their services to the state’s residents and last week sent letters to thirteen firms saying they are violating state law, California Department of Health spokesperson Lea Brooks told BioArray News sister publication GenomeWeb Daily News this week.
The state will not disclose the names of the firms to which it has sent letters, or which laws their services violate, until the companies in question verify with the state that they have received the warnings, Brooks said.
With the move to begin regulating consumer genomics companies in the state, California follows New York State, which less than two months ago warned 23 companies that they must have permits to offer their services to New Yorkers (see BAN 4/29/2008).
New York’s warning letter was a shot across the bow not only to new companies, such as Navigenics and 23andMe, that last year entered into the fledgling field of consumer genomics, but also to technology suppliers Affymetrix and Illumina, which make the tools the testing companies use.
Whether California is focusing on consumer genomic testing companies or if it has broadened its authority to include technology suppliers will not be known until the authorities release the names of the companies it is contacting. California authorities also have not said whether information has been referred to the state’s Attorney General for further action.
CIDR Using Affy's SNP Array 6.0 for Inherited Disease Studies Services
The Center for Inherited Disease Research is using Affymetrix’ Genome-Wide Human SNP Array 6.0 for large-scale genotyping and copy number projects conducted for researchers working through the National Institutes of Health, Affymetrix said this week.
The federally funded CIDR is based at Johns Hopkins University and focuses on offering genotyping and statistical genetics services to scientists who are trying to identify genes that could contribute to human multifactorial hereditary diseases.
The first such project using the Affymetrix technology is a study of the genetic causes of type 2 diabetes in African Americans and is funded through the National Institute of Diabetes and Digestive and Kidney Diseases, the company said.
Affy said its genome-wide mapping arrays have been used recently in similar studies of type 2 diabetes in Nordic and Parsi populations.
Financial terms of the agreement were not released.
More information about CIDR’s services, which are available to all investigators through competitive peer review, may be found at the center’s website.
Med BioGene, Duke Expand Lymphoma Dx Collaboration
Med BioGene said last week that it has expanded its lymphoma diagnostics collaboration with Duke University to include additional collaborators from Northwestern University, Indiana University, and the University of Hong Kong.
Vancouver, BC-based Med BioGene said the expansion of the collaboration was facilitated through Duke’s establishment of the Working Group in Hematologic Malignancies. The first project of the group is to develop genomic-based tests for lymphoma, including Med BioGene’s LymphExpress Dx.
Med BioGene and Duke formed their collaboration in March 2007 to develop and validate biomarkers for lymphoma and leukemia. Under that collaboration, Duke is providing samples for Med BioGene’s gene expression-profiling system.
Erinn Broshko, CEO of Med BioGene, said that the expanded alliance “provides a significant base of expertise in all required areas and patient samples for analysis.”
Veridex to Acquire Assets of Immunicon for $31M
Johnson & Johnson company Veridex said last week that it will acquire substantially all of the assets of cancer diagnostics firm Immunicon for $31 million in cash.
The assets involved in the sale include intellectual property, product inventory, clinical data, and all technologies related to Immunicon’s CellSearch system, which automates the detection and enumeration of circulating tumor cells. The system is currently cleared for the prognosis and monitoring of patients with metastatic breast, metastatic colorectal, and metastatic prostate cancer.
Immunicon is currently in bankruptcy proceedings, and the bankruptcy court overseeing its case must approve the deal. Veridex said that the acquisition price is subject to certain closing adjustments, plus the discharge and release of certain claims owed to Veridex, and the assumption of certain liabilities.
The firms have been collaborators since 2000 in developing cancer diagnostic platforms and products.
BioForce Nanosciences Closes $300K Convertible Debt Financing
BioForce Nanosciences said last week that it has closed a $300,000 convertible debt financing from its largest shareholder.
The Ames, Iowa-based company said the investment involved issuing $300,000 of convertible secured promissory notes, which are convertible into shares of the firm’s common stock at $.30 per share, and the issuance of 900,000 warrants for the company’s common stock at $.30 per share.
Investors in this round include FCPR SGAM AI Biotechnology Fund and three of BioForce’s executive officers: President and CEO Kerry Frey, Chief Science Officer Eric Henderson, and CFO Greg Brown.
BioForce’s Nano eNabler system is used in developing biosensors and therapeutic agents based on single cell analysis.
Brown said that the deal is “an important piece of our overall financing strategy for 2008, which will allow us to support our expanded distribution network and development of the market for our recently announced custom patterned surfaces offering.”
Invitrogen to Acquire Applied Biosystems for $6.7B
Invitrogen and Applied Biosystems announced last week that Invitrogen will acquire all of the outstanding shares of ABI in a cash and stock deal valued at $6.7 billion.
The acquisition combines Invitrogen’s portfolio of reagents and low-cost instruments focused on the molecular and cell biology and protein research markets with ABI’s vast array of consumables and instruments for applications such as DNA sequencing, proteomics, RNAi, gene expression, and applied testing.
The combined company, which will retain the Applied Biosystems name but will be based at Invitrogen’s headquarters in Carlsbad, Calif., will have approximately $3.5 billion in revenue, of which roughly 70 percent will come from consumables and services.
Invitrogen Chairman and CEO Greg Lucier and ABI President and COO Mark Stevenson will hold the same roles in the combined company. The board of directors will include nine current Invitrogen board members and three ABI board members, though the firms did not disclose the names of those directors.
The combined firm will boast a sales and service force of approximately 3,000 employees and have customers in more than 100 countries.
Under terms of the deal, ABI shareholders will receive $38 for each share they own in the form of Invitrogen stock and cash, with cash accounting for 45 percent of the split. The purchase price represents a 12 percent premium to ABI’s average closing price for the previous 30 trading days.
The firms expect the transaction to close in the fall, pending regulatory and shareholder approval.