Medical Device Link.

Originally Published IVD Technology July 2004

INDUSTRY NEWS

Nanobac Life Sciences (Tampa, FL) is nearing completion of the development of a biodiagnostic test for nanobacterial infection, which may contribute to coronary artery disease and kidney dysfunction. One portion of the test detects a specific nanobacterial component, or antigen, and another uses antibodies to recognize the nanobacteria. A prototype of the test has undergone a successful preliminary clinical evaluation, and the company says that the test is now in the final stages of development.


Wendel Investissement (Paris) has decided to sell its shares of bioMérieux (Marcy l’Etoile, France), which amount to 35% of bioMérieux’s stock. As Wendel is bioMérieux’s largest minority stakeholder, this sale may compel the IVD company to go public. Although the firm has filed papers with the Bourse, France’s stock trading center, for an initial public offering, bioMérieux is still considering finding a private buyer for Wendel’s stock.


At an April 23 meeting of the Association of Medical Diagnostics Manufacturers (Washington, DC), FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD; Rockville, MD) reported that its data integrity or fraud cases have been resulting mostly from 510(k) reviews rather than premarket approval (PMA) applications. Due to this trend, IVD 510(k) data will be scrutinized more closely by FDA. 

According to OIVD, four diagnostics firms that have received application integrity policy (AIP) letters thus far received the letters as a result of problems with their 510(k) submissions. However, OIVD plans to continue its policy of favoring informal and interactive methods of resolving compliance issues.


Exact Sciences (Maynard, MA) plans to boost the sales of its PreGen-Plus molecular-based colorectal cancer test via a two-pronged approach. First, the company has submitted results of the test’s clinical trials to a peer-reviewed publication, and expects the study to be published later this year. Company representatives hope that publication of results demonstrating that the test is superior to conventional fecal occult blood tests (FOBT) will give the test more weight in the clinical arena. Second, the company will begin a direct-to-consumer marketing campaign to boost consumer awareness of the test and its advantages in terms of sensitivity of the test and simplicity of test protocol when compared with traditional FOBT.


Bayer Diagnostics (Tarrytown, NY) has been dissolved and reincarnated as two separate diagnostics units: Bayer HealthCare Diagnostics Self-Testing Systems Division (STS; Elkhart, IN) and Bayer HealthCare Diagnostics Professional Testing Systems Division (PTS; Tarrytown, NY). 

Bayer HealthCare (Leverkusen, Germany) split the diagnostics portion of its business into these two divisions in order to “better address the very different business decisions that exist in different parts of the diagnostics market,” said a Bayer representative. 

The STS unit will focus on home glucose monitors sold directly to consumers, while the PTS unit will be responsible primarily for the company’s instruments and consumables geared toward high-volume clinical labs.

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