A Diagnostics & Imaging Week

Bayer HealthCare Diagnostics (Tarrytown, New York) said it has been granted licenses under patent rights relating to free prostate specific antigen (PSA) and tacrolimus tests from Abbott Laboratories (Abbott Park, Illinois).

Bayer said it intends to develop these two new tests for its Advia Centaur and Advia Centaur CP immunoassay systems immediately.

"By adding free PSA to the oncology portfolio, Bayer HealthCare Diagnostics will have a very comprehensive diagnostic menu for prostate cancer markers," said Samir Taneja, MD, director of urologic oncology, NYU Cancer Institute and School of Medicine (New York).

The company said the flexibility would allow physicians to select the tests they feel most appropriate to differentiate malignant and benign prostate disease within the individual patient.

"The addition of fPSA and tacrolimus to our assay offering will enhance the laboratories ability to increase their test offering while optimizing their overall efficiency," said Tom Warekois, senior vice president global strategic marketing, Bayer Diagnostics. "This is another example of [our] commitment to expanding the test offering for immunosuppression drugs. Tacrolimus is complementary to cyclosporine, which is currently also in development and scheduled to release in 2006."

The free PSA test is primarily ordered when a patient has a moderately elevated total PSA that does not appear to be caused by a non-cancer-related condition. The results give the doctor additional information about whether a patient is at an increased risk of having prostate cancer and helps with the decision of whether to biopsy the prostate.

The tacrolimus test is designed to determine the amount of immunosuppressant drug in the patient's system. Primarily, the drug tacrolimus is used as an immunosuppressant in liver transplant patients.

NeoGenomics (Fort Meyers, Florida) reported that it had reached agreements for up to $600,000 of new equity financing for the company as well as planned amendments to its credit facility.

As part of these agreements, a new investor to the company has purchased 2 million restricted shares of the company's common stock at a purchase price of 20 cents a share, which has resulted in $400,000 of new equity capital coming into the company.

This investor also was granted a warrant to purchase 900,000 shares of common stock at an exercise price of 26 cents a share.

As part of the equity agreements and planned credit facility amendment, the company also granted the right to purchase an additional $200,000 of equity under the same terms by April 30 to Aspen Select Healthcare, its largest shareholder and creditor, provided that if Aspen elects not to exercise such rights, then the company may make such shares available for purchase to the new investor.

Under the terms of the planned credit facility amendment, the company and Aspen have agreed to extend the maturity date until Sept. 30, 2007, and increase the availability of such credit facility by up to $200,000 in certain circumstances.

In addition to other items, the planned amendment will provide the company with the ability to access up to $500,000 in secured vendor financing and/or lease arrangements.

NeoGenomics is a clinical laboratory that offers genetic and molecular cancer diagnostic testing services.

In other financings-related news:

Biophan Technologies (West Henrietta, New York), in a Securities and Exchange Commission filing, said it has received a $5 million credit facility from Biomed Solutions (Encinitas, California), a company headed by Biophan CEO Michael Weiner.

Biophan said it cannot use the $30 million financing committed to it by SBI Brightline XI (Irvine, California) until its registration statement is declared effective. The SBI financing results in an average price of $3 a share, assuming Biophan elects to sell all 10 million shares to SBI.

The Biomed facility gives Biophan access to up to $1.5 million monthly. Biomed will receive warrants to buy just under 1.2 million shares of Biophan stock at a 10% premium.

To acquire the capital to supply the credit facility, Biomed privately sold 4 million shares of stock and 1.18 million warrants.

Weiner said that Biomed "is willing to sell some of its holdings in order to provide Biophan with interim financing so Biophan's momentum is undeterred."

Biophan develops technologies designed to make devices safe and image-compatible with MRI.

Quest Diagnostics (Lyndhurst, New Jersey) said its board expanded its share repurchase authorization by $600 million, bringing the amount available for repurchase to $722 million. The company in 2005 repurchased 7.8 million common shares for $390 million; it had about 199 million shares outstanding as of Jan. 23.

The board also declared a quarterly cash dividend of 10 cents a common share, an 11% increase, payable on April 19.

Quest is a major provider of diagnostic testing, information and services.

Somanetics (Troy, Michigan) reported filing a registration statement with the Securities and Exchange Commission for a proposed public offering of 2.1 million common shares, in which the company expects to sell 2 million shares and a selling shareholder selling the remaining shares. In addition, Somanetics will grant the underwriters an option to purchase up to another 315,000 shares to cover over-allotments.

Somanetics said it would use the net proceeds from the offering for the expansion of its direct sales team and other sales and marketing activities; to sponsor additional clinical trials; to expand research and development efforts; and for working capital and general corporate purposes, including potential acquisitions of complementary products, technologies or businesses.

Citigroup Global Markets is the sole bookrunning manager of the offering. SG Cowen & Co. is co-lead manager and SunTrust Capital Markets and Rodman & Renshaw are co-managers.

Somanetics manufactures the Invos System, a non-invasive patient monitoring system that continuously measures changes in the blood oxygen levels in the brain.

The company received 510(k) clearance last November to market the Invos System to monitor changes in blood oxygen saturation elsewhere in the body in somatic, or skeletal muscle, tissue in patients with or at risk for restricted blood flow.

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