Ciphergen not in NASDAQ compliance

Ciphergen Biosystems (Fremont, California) said that it received a letter from the NASDAQ stock market that indicated the company is not in compliance with Marketplace Rule 4310(c)(3), which requires it to have (i) a minimum of $2.5 million in stockholders’ equity; (ii) $35 million market value of listed securities; or (iii) $500,000 of net income from continuing operations for the most recently completed fiscal year or two of the three most recently completed fiscal years.

In accordance with Marketplace Rule 4310(c)(8)(C), the company has a minimum of 30 calendar days, or until Sept. 14, to regain compliance. If, at any time prior to Sept. 14 the market value of the company’s common stock is $35 million or more for at least 10 consecutive business days, NASDAQ may determine that the company complies with this rule. Ciphergen Biosystems makes diagnostic tests that help physicians diagnose, treat and improve outcomes for patients.

Novadaq restates financial statements

Novadaq Technologies (Toronto) said that it has filed restated unaudited interim financial statements for the three months ended March 31, 2007 with the Canadian securities regulatory authorities. The restatement has no impact on previously reported net income, earnings per share, revenue, cash, total assets, or shareholder’s equity and only relates to the accounting treatment, in the company’s Consolidated Statement of Cash Flows of the assets acquired from Edwards Lifesciences (Irvine, California) relating to the exclusive distribution rights to PLC Medical System’s (Franklin, Massachusetts) Heart Laser System for transmyocardial revascularization in the U.S.

Novadaq has restated the consolidated statement of cash flows for the three months ended March 31, 2007 to reclassify the acquisition of inventory and assumption of accounts payable related to the Edwards TMR business as investing activities, rather than non-cash working capital changes relating to operations. Novadaq Technologies makes medical imaging systems and real-time image guided therapies for use in the operating room.

StatSure HIV test has completed trials

StatSure Diagnostic Systems (Framingham, Massachusetts) said that its patented, “barrel- test” format for the detection of antibodies to HIV-1/2 in human whole blood, serum, and plasma has completed the trials needed for a CLIA waiver application and that the results have been submitted to the FDA for their review. The company believes the results of these trials were consistent or superior to those of other rapid point of care products that have received a CLIA waiver. The HIV 1/2 product is marketed and distributed worldwide by Inverness Medical Innovations (Waltham, Massachusetts) under its Clearview brand as “Clearview COMPLETE HIV.”

StatSure Diagnostic Systems makes rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases.

CMS accepts Exact’s cancer coverage application

Exact Sciences (Marlborough, Massachusetts) said that the Centers for Medicare & Medicaid Services (CMS; Washington) has accepted its application requesting a national coverage determination for the company’s DNA-based colorectal cancer (CRC) screening technologies. While there is typically a nine- to twelve-month statutory period from application acceptance to a final CMS coverage determination, CMS has indicated that it expects to complete the national coverage analysis by May 1, 2008.

Medicare beneficiaries include 43 million of the approximately 87 million people in the U.S. over age 50 for whom regular screening is recommended. Claims data from 1998-2002 suggest that only about 31% of Medicare beneficiaries have ever had a CRC screening test. Moreover, since 69% of newly diagnosed cases of CRC occur in people aged 65 and older, Medicare assumes a significant portion of the costs associated with CRC treatment.