deCODE Launches First Genetic Test
for Risk of Type 2 Diabetes
deCODE (Reykjavik, Iceland) announced it will offer a test for a genetic risk factor for type 2 diabetes, the company’s first commercial product to reach the market since the conclusion of its exclusive population-level genetic studies in Iceland. The test will be offered at deCODE’s Woodridge, Ill., CLIA-certified laboratory. Called the deCODE T2, the assay detects a single SNP that in deCODE’s and other research was shown to correspond to a 2-fold increase in the risk of type 2 diabetes. “Understanding one’s risk of type two diabetes is the first step toward enabling more effective prevention,” said deCODE CEO Kari Stefansson. “The principal risk factors are well known—obesity, unhealthy diet, and lack of exercise—and by addressing these, individuals can reduce their risk of becoming diabetic. Family history, part of which involves genetic risk factors, also plays a part. deCODE T2 offers a new tool to help individuals and their doctors bring an understanding of inherited risk into the picture.” Stefansson also said that the company has several more DNA-based genetic predisposition tests for common diseases in development.
Cepheid, IL Develop Thrombosis Risk Test
Cepheid (Sunnyvale, Calif.) and Instrumentation Laboratory (IL, Lexington, Mass.) announced an agreement to co-develop molecular diagnostics tests for hemostasis. The first tests will be the Xpert HemosIL Factor II (FII) and Factor V (FV) assays for the detection of FII and FV genetic variations associated with an increased risk of blood clots. Under the agreement, Cepheid will develop a line of these and other tests for hemostasis to be used on its GeneXpert system, and IL will market the tests as a complement to its own panel of hemostasis diagnostics. “Because of the complexity of the technologies currently available, clinical laboratories often send samples to specialized molecular biology centers, with a turnaround time of up to one week,” said Cepheid CEO John Bishop. “The introduction of GeneXpert and FII and FV molecular tests in the hemostasis laboratory will have a significant impact in allowing the routine hospital or independent laboratory to perform these tests in-house, while reducing the cost and improving turnaround time.” The GeneXpert FII and FV tests are still in development, and Cepheid said it is aiming for FDA review later this year. Financial terms were not disclosed.
LabCorp Working on Breast Cancer Tests
Under a license agreement with Rockville, Md.-based Celera, LabCorp (Burlington, N.C.) said it plans to commercialize two new molecular oncology laboratory service tests. The license allows LabCorp to apply Celera’s breast cancer metastasis and estrogen/progesterone receptor discoveries. LabCorp said it will offer one test to help predict the risk of metastasis in early-stage breast cancer patients, and a second test to provide a molecular assessment of hormonal receptor status to select women for endocrine therapy. “This license agreement with Celera strategically complements our innovative and extensive pipeline of diagnostic services and reinforces our strong commitment to genetic and molecular oncology testing,” said LabCorp CEO Myla Lai-Goldman, MD. “Applying Celera’s findings in breast cancer to the development of new tests supports our ever-growing menu of esoteric and genomic tests, and underscores our commitment to bring relevant clinical tests to market.” LabCorp said that the tests would provide different information than what is predicted by routine clinical assessment tools and that the test could also quantify the risk of metastasis for time periods other than narrow 5 or 10 year categories. Financial terms were not disclosed.
Qiagen Acquires eGene
Qiagen, (Venlo, The Netherlands) announced that it has signed a $34 million cash and stock deal to acquire Irvine, Calif.-based eGene, a 3-year-old company that is working to bring to market a patented sample separation and analysis technology based on capillary electrophoresis. “The eGene solutions leverage and seamlessly combine with Qiagen sample and assay technologies and create novel and highly attractive molecular diagnostics solutions to our customers in clinical research, applied testing, and molecular diagnostics,” said Qiagen CEO Peer Schatz.
Wal-Mart to Open Up to 2,000 In-Store Clinics
Wal-Mart (Bentonville, Ark.) announced that it plans to open as many as 400 in-store health clinics over the next 2 to 3 years, and up to 2,000 clinics over the next 5 to 7 years if market forces continue. The health clinics, which will lease space in Wal-Mart stores and be managed by local or regional hospitals and other organizations that are independent of Wal-Mart, will offer preventive and basic non-emergency care and include some laboratory tests, such as cholesterol screenings. “We know that customers like and want these clinics,” said Wal-Mart CEO Lee Scott. “At existing clinics in our stores, about ninety percent of patients report being satisfied or very satisfied. They appreciate the fast, easy, and convenient experience.”