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Invitrogen, Applied Biosystems, AutoGenomics, Wellcome Trust, Affymetrix

Invitrogen's Acquisition of Applied Biosystems Clears Antitrust Waiting Period
Invitrogen said this week that its proposed acquisition of Applied Biosystems has cleared the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Invitrogen said it will “soon” begin a similar process with European regulatory authorities.
The acquisition is expected to close in late October or early November, subject to approval of both companies' shareholders (see BAN 7/15/2008).
Invitrogen said that integration team members from both companies met last week “to discuss proposed milestones and activities for the integration and further review proposed synergies.”
Mark Smedley, Invitrogen's global head of operations and leader of the integration team, said in a statement that the companies have “a clear integration model in place and we are well on track to start delivering on the potential of our new company as soon as the transaction closes."

AutoGenomics Files for IPO
Molecular diagnostics firm AutoGenomics has filed a preliminary prospectus with the US Securities and Exchange Commission to float an unspecified number of common shares in an initial public offering on the Nasdaq Global Market.
The firm did not offer an estimated price range for the shares in the offering or a preliminary estimate of net proceeds. However, the filing lists the proposed maximum aggregate offering price at $86.3 million.
Autogenomics makes the Infiniti molecular diagnostics system, which was cleared by the US Food and Drug Administration for marketing in February 2007. The firm currently offers 26 test applications on the system, including research-use-only tests for HPV, respiratory illness, breast and bladder cancer risk, and cystic fibrosis. The Carlsbad, Calif.-based company also has FDA clearance for a warfarin sensitivity test and for Factor II, Factor V, and Factor II-V panel tests.
According to its prospectus, AutoGenomics had an installed base of 58 Infiniti analyzers in reference labs, hospital labs, and specialty clinics throughout North America. Its customers include ARUP Laboratories, Cleveland Clinic, The Johns Hopkins Hospital, and the Montreal Heart Institute, among others.
AutoGenomics intends to discuss with the FDA in an upcoming meeting the design of a clinical trial for its human papillomavirus screening test, and it estimates that the PMA process for such a test could take two to three years or longer. It also intends to submit a 510(k) with the FDA next year for its HPV genotyping test.
The firm said that it would use proceeds from the offering to fund clinical studies on the HPV screening test and for other R&D activities, as well as for additional working capital and general corporate purposes.
For fiscal 2007, AutoGenomics had product sales of $1.6 million and a net loss of $9.3 million.
As of March 31, the firm had cash and cash equivalents of $9.3 million.
JP Morgan Securities is sole book-running manager for the offering. Deutsche Bank Securities is co-lead manager, and Pacific Growth Equities and Robert W. Baird are acting as co-managers.

Wellcome Trust, Affy Expand Genotyping Study
UK non-profit the Wellcome Trust will use Affymetrix’s genotyping technologies for the second phase of its Case Control Consortium project, Affy said last week.
The WTCCC is a group of UK researchers who began in 2005 studying thousands of genotyped human samples for genes associated with coronary heart disease, hypertension, types 1 and 2 diabetes, bipolar disorder, Crohn's disease, rheumatoid arthritis, and tuberculosis.
For this second phase of the program, researchers will analyze genetic information from 30,000 individuals using Affy’s Genome-Wide Human SNP Array 6.0, as well as 6,000 common controls, the company said.
The consortium is also using Illumina arrays for the project.
In this leg of the study, the 14 research groups involved in the WTCCC aim to analyze the genetic information of 60,000 individuals for genetic links to 14 diseases and drug responses. These include schizophrenia, ulcerative colitis, psychosis, bacteriosis, pre-eclampsia and statin response, and a genome-wide association study of learning difficulties.
In the first study, the WTCCC detected 24 genetic associations across bipolar disorder, Crohn's disease, hypertension, rheumatoid arthritis, and type 1 and type 2 diabetes.
The company said the genotyping services are being conducted through a partnership with the Affymetrix Services Lab.
Financial terms of the agreement were not released.

The Scan

Breast Cancer Risk Related to Pathogenic BRCA1 Mutation May Be Modified by Repeats

Several variable number tandem repeats appear to impact breast cancer risk and age at diagnosis in almost 350 individuals carrying a risky Ashkenazi Jewish BRCA1 founder mutation.

Study Explores Animated Digital Message Approach to Communicate Genetic Test Results to Family Members

In the Journal of Genetic Counseling, the approach showed promise in participants presented with a hypothetical scenario related to a familial hereditary breast and ovarian cancer syndrome diagnosis.

Computational Tool Predicts Mammalian Messenger RNA Degradation Rates

A tool called Saluki, trained with mouse and human messenger RNA data, appears to improve mRNA half-life predictions by taking RNA and genetic features into account, a Genome Biology paper reports.

UK Pilot Study Suggests Digital Pathway May Expand BRCA Testing in Breast Cancer

A randomized pilot study in the Journal of Medical Genetics points to similar outcomes for breast cancer patients receiving germline BRCA testing through fully digital or partially digital testing pathways.