Animas files quarterly report
Animas (West Chester, Pennsylvania) reported the filing of its quarterly report on Form 10-Q for the period ended Sept. 30, within the extension period provided. As previously reported, the company’s audit committee was conducting an investigation in connection with an anonymous letter referencing issues regarding a non-executive employee and the receipt of payments from certain commercial payors.
The investigation has been completed, and no evidence was found to support the allegations, Animas said. The audit committee and its independent advisors have concluded that no changes are required to the company’s previously announced financial results for the quarter ending Sept. 30, or for any earlier periods.
“As we expected, the allegations in the anonymous letter were shown to be without merit, and the named employee has been completely exonerated,” said Kathy Crothall, president and CEO. “Though a thorough investigation was necessary given the company’s commitment to good corporate governance, we have always had the utmost confidence in our controls and our employees.”
Response achieves flu test targets
Response Biomedical (Vancouver, British Columbia) reported that it has successfully achieved its analytical sensitivity targets for its Flu A Test. It is intended that the test be commercialized for both human and animal applications.
Using a variety of Flu A strains, the performance results to date indicate that the RAMP Flu A Test produces results that are in excess of 100 times more sensitive than commercially available rapid influenza A tests, the company said.
Response Biomedical also reported that it has initiated development of a separate RAMP test to specifically identify only the H5N1 strain, the lethal form of avian flu that is spreading internationally and threatens to cause a global influenza pandemic.
Strategic Diagnostics not in Nasdaq compliance
Strategic Diagnostics (Newark, Delaware), a provider of biotech-based detection solutions for a range of healthcare and scientific applications, said that it has received a letter from Nasdaq stating that it is not in compliance with Nasdaq rules requiring timely filing of its quarterly report for the period ended Sept. 30, and that the company’s common stock is therefore subject to delisting.
As a result, the letter “E” was added to the company’s trading symbol at the opening of business Nov. 23.
The company has requested a hearing, which will stay the delisting until a final decision is made.
Bayer Diagnostics in agreements with Inverness
The Bayer HealthCare Diagnostics Division (Tarrytown, New York), a member of the Bayer Group (Leverkusen, Germany) and Inverness Medical Innovations (Waltham, Massachusetts), a manufacturer of diagnostic products, reported signing four agreements to broaden their assay menu offerings worldwide in the diagnostics arena.
The first agreement will expand access for physicians and healthcare providers worldwide, excluding Japan, to diagnose congestive heart failure using a point of care assay for B-type natriuretic peptide (BNP) testing.
Recent research has shown that elevated levels of BNP are an indicator of heart failure, thus providing physicians with an important diagnostic tool in the early detection and management of heart failure.
BNP is a rapidly expanding area for cardiovascular testing. The BNP molecule is physiologically active and serves as a biological response to cardiovascular stress.