New Breast Cancer Test Broadens Options
A new genetic test from Invitrogen Corp. (Carlsbad, California) to determine whether patients with breast cancer are good candidates for treatment with the drug trastuzumab (Herceptin) has been approved. The SPOT-Light human epidermal growth factor receptor 2 (HER2) chromogenic in situ hybridization (CISH) kit measures the number of copies of the HER2 gene in tumor tissue. Patients who have more than two copies of the HER2 gene and overproduce the HER2 protein are typically treated with trastuzumab, which targets the HER2 protein production to help stop the growth of HER2 cancer cells.
When used with other clinical information and lab tests, this test can provide additional insight on treatment decisions for patients with breast cancer. Unlike existing tests, the SPOT-Light allows labs to store the tissue for future reference.
For more information, visit http://www.invitrogen.com.
FDA Approves Gene Expression Test
The FDA has approved the Pathwork Diagnostics (Sunnyvale, California) Tissue of Origin Test to facilitate diagnosis of tumors that are difficult to identify. The test uses microarray technology for genetic analysis and considers 15 common malignant tumors, which include those originating in the bladder, breast, and colorectal region. The test allows simultaneous measurement of gene expression levels of large numbers of genes in small DNA fragments, converts scanned image data to gene expression measurements, and compares the data with known gene expression patterns of different tumor types.
The gene expression test is currently available through Pathwork's Clinical Laboratory Improvement Amendments certified lab and will be available as an in vitro diagnostic kit, allowing clinical labs to perform the test themselves.
For more information, visit http://www.pathworkdx.com.
Blood Test Monitors Colorectal Cancer
AMDL (Tustin, California) has received the FDA approval to market the AMDL-ELISA DR-70 (FDP) as a safe and effective blood test for monitoring patients who have been previously diagnosed with colorectal cancer. The test was approved on the basis of data showing that it has the ability to monitor the progression of colorectal cancer postsurgery in patients who are biopsy confirmed with this disease.
The approval marks the first clearance to market that the FDA has granted for any monitoring product for colorectal cancer since 1982, when Carcinoembryonic Antigen (CEA) was approved. The DR-70 is a new test that can monitor colorectal cancer tumors postsurgery.
For more information, visit http://www.amdl.com.
New CO2 Laser System Offers Safe Solutions
The FDA has approved Lutronic Inc.'s (Princeton Junction, New Jersey) eCO2 fractional laser system. Using the proprietary Controlled Chaos Technology, this next generation fractional CO2 laser is designed to offer a safe and innovative way to treat deep ablative indications such as resurfacing and coagulation of soft tissue, textural irregularities, fine lines, pigmented lesions, vascular dyschromia, and rhytides. The eCO2 has several features that allow customizable treatments that are easy to use and less painful to the patient.
Initial biopsy studies indicate that the laser can penetrate as deep as 2.4 mm into the dermis. The device can perform incisional surgery, traditional ablative resurfacing, and ablative microfractional photothermolysis. It can also combine two operational modes in one delivery system, and can "feather" the treatment area to reduce the "checkerboard" appearance common with currently available fractional CO2 devices.
For more information, visit http://www.lutronic.com.