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Abbott, Compugen, Affymetrix, Wellcome Trust, AutoGenomics, Hologic, Third Wave

Abbott Has No Intentions to Sell Dx Businesses, Officials Say
A year after an $8.1 billion agreement to sell two of its diagnostic divisions to General Electric fell apart, Abbott Laboratories has no intentions of getting rid of those divisions or any other parts of its diagnostics business, company officials said this week at the annual meeting of the American Association for Clinical Chemistry.
Speaking at a press conference held here at the National Press Club, Abbott Executive Vice President of Diagnostics Edward Michael said that the firm had been approached by possible suitors since the collapse of the GE deal, reports Pharmacogenomics Reporter sister publication GenomeWeb Daily News. However, over the past year, and the past two quarters in particular, the diagnostics business has demonstrated “great improvement” in sales and profitability, he said.
In addition, Michael said that in the wake of the collapsed deal Abbott evaluated the business and decided that not only could it perform better but it also could help the firm’s pharmaceuticals and nutritional business grow. Similar to a strategy being employed by its rival Roche, Abbott sees companion diagnostics being a revenue driver for its other businesses – and it also can aid in its R&D efforts.
Abbott’s diagnostics business brought in revenues of around $3.1 billion in 2007, with around $250 million coming from the molecular diagnostics business, which was not part of the GE pact. In addition, Abbott’s point-of-care Dx business, which was part of the deal, generated revenues of roughly $200 million. Michael said that both of these parts of the diagnostics business had revenue growth of more than 20 percent in the second quarter of 2008.
The firm, which sells a PCR-based HIV assay, is working on a wide variety of infectious disease molecular diagnostic assays, particularly for sexually transmitted diseases, that it hopes to eventually sell in the US. It hopes to seek European clearance for a human papillomavirus assay later this year, but will hold off on seeking US approval until Qiagen’s patents covering the technology expire in the US.
Another expansion of Abbott’s molecular diagnostics business could come through its possible acquisition of Ibis Biosciences, a division of Isis Pharmaceuticals in which Abbott holds a nearly 20 percent stake.
An Abbott official told GenomeWeb Daily News after the press conference that the firm is likely to exercise its option to acquire Ibis for an additional $175 million to $190 million at the end of this year. Ibis’ T5000 Biosensor System combines PCR with mass spectrometry to identify and characterize infectious agents. It is not ready for the clinical market yet, said Michael during his presentation, but Abbott could help in further developing the system and seeking regulatory clearance for clinical diagnostic uses.
John Robinson, senior director of R&D for Abbott Molecular, also noted that the company is keeping its eye on a variety of research tools, including next-generation DNA sequencers, as potential content generators for its molecular diagnostics business. The firm also has an ongoing molecular diagnostics collaboration with Celera, but Robinson said Abbott’s relationship with that firm could change now that Celera has split with former sister company Applied Biosystems.

Compugen Narrows Q2 Net Loss, Appoints New CFO
Compugen this week posted $40,000 in revenues for the second quarter of 2008, compared to no revenues in the comparable period of 2007, accompanied by a 6 percent improvement in its second-quarter net loss.
The company also announced the appointment of Dikla Czaczkes Axselbard as chief financial officer, succeeding Ronit Lerner, who resigned from the company. Axselbard served as director of finance for Compugen from 2002 through 2007, and has served as acting CFO since February.
Compugen’s net loss for the quarter ended June 30, 2008, was $3 million, including a non-cash expense of $416,000 related to stock-based compensation, or $0.10 per share. The company’s net loss for the year-ago period was $3.2 million, including a non-cash expense of $436,000 related to stock-based compensation, or $0.11 per share.
The company reported R&D expenses of $2.4 million for the second quarter of 2008, compared to $2.3 million for the second quarter of 2007. Sales and marketing expenses rose 30 percent to $355,000 from $272,000 in the comparable period of 2007.
As of June 30, Compugen had $12.6 million in cash, cash equivalents, deposits, and marketable securities.

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.

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.

Hologic Completes Third Wave Purchase
Hologic completed its $580 million acquisition of Third Wave Technologies after the close of business last Thursday.
The Bedford, Mass.-based medical imaging and diagnostics firm said that as of midnight on July 23, Third Wave shareholders had tendered 47,968,050 shares of the firm, representing 95.8 percent of Third Wave’s outstanding stock. Hologic paid $11.25 per share for Third Wave’s stock, which stopped trading on the Nasdaq on July 24.
The acquisition, which was announced in early June, will provide Hologic with complementary products targeted to the women’s health and diagnostics market. The Bedford, Mass.-based firm sells the ThinPrep pap test, while Madison, Wis.-based Third Wave recently filed for US Food and Drug Administration clearance for two molecular diagnostic tests for human papillomavirus.

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