This Week in Diagnostics

FDA clears assay from Critical Diagnostics

The FDA has cleared Critical Diagnostics’ Presage® ST2 Assay for use as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The assay, the company says, quantitatively measures the level of ST2 in blood. ST2 has been shown to be a significant predictor of mortality as well as all-cause hospitalization, mortality due to cardiovascular disease, and hospitalization due to cardiovascular disease. ST2 is prognostic for clinically important outcomes in addition to all-cause mortality.

This latest regulatory achievement follows the granting earlier this year of a CE Mark in Europe reports David Geliebter, Chairman of Critical Diagnostics.

Saladax expands distribution of My5-FU in Europe

Saladax Biomedical says that it has entered into distribution agreements with Genoxa of Puck, Poland and AB ANALITICA of Padua, Italy, for My5-FU™, a test that measures levels of a widely-used anti-cancer drug, 5-fluorouracil (5-FU), in the blood of cancer patients.

Genoxa, a privately owned clinical reference laboratory focused on providing personalized medicine testing services, will be the exclusive provider of My5-FU testing services to oncologists in Poland, enabling them to individualize the dose of 5-FU to optimize therapeutic efficacy and reduce toxicity for their patients.

In Italy, AB ANALITICA will be the exclusive distributor of My5-FU testing kits to hospital and reference laboratories.

FDA approves Hologic’s system for cervical cancer screening

The FDA has approved the Cervista HTA (high throughput automation) system for use with the Hologic’s’s previously approved Cervista human papillomavirus (HPV) HR test. The company’s HPV HR test utilizes its proprietary Invader technology to detect 14 high risk types of HPV that are associated with cervical cancer and precancerous lesions.

Dako’s HER2 CISH pharmDx kit approved

Dako says it has received FDA approval to market HER2 CISH pharmDx™ Kit in the United States. This new diagnostic test is specifically developed as an aid in the assessment of breast cancer patients for whom treatment with Herceptin® is being considered. It allows pathologists to perform validated FISH tests and score the results using readily available bright field microscopes.

Ventana and Advanced Cell Diagnostics enter into agreement

Ventana Medical Systems, a member of the Roche Group, and Advanced Cell Diagnostics (ACD), are reporting they have entered a worldwide co-promotion agreement for the first commercially available, fully automated RNA in situ hybridization (ISH) assay system capable of detection and visualization of virtually any expressed gene in routine clinical specimens at single-molecule sensitivity.

The two companies have partnered to automate this assay system on the Ventana Discovery series slide staining platforms. The product offerings are expected to become commercially available in the first quarter of 2012 and will initially be offered for research-use only applications.

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