Molecular Diagnostics
Differential scanning calorimetry in molecular diagnostics
Calorimetry is the science of measuring the heat absorbed or released in a chemical reaction or physical transition. It provides a direct physical measurement of what is perhaps the most fundamental property of chemical and biochemical reactions: the change in heat.1,2 The field of calorimetry dates back to the late 18th century and the Scottish physician Joseph Black, whose work represents some of the early developments of modern thermodynamics.3 The first practical calorimeter was developed...
Companion Diagnostics: A Blossoming Field
Companion diagnostics are emerging as a key part of personalized medicine. Particularly in oncology, patients are being better served by drugs for which patients are selected via in-vitro diagnostic tests. The field is promising but nascent: so far, the potential of companion diagnostics is greater than the number of drug-and-diagnostic products that is actually commercially available. To find out why this is the case, and to learn more about the future of companion diagnostics, IVD...
Appeals court overturns ruling on gene patents
In the ongoing legal saga that could significantly affect the development of molecular diagnostics, the Federal Circuit Court of Appeals in Washington, DC partially reversed a lower district court’s earlier ruling in a case challenging patents on two human genes associated with breast and ovarian cancer. The appeals court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences. “The ruling is a blow to the idea that patent law...
Sidebar: How to Submit an Idea to GE’s Healthymagination Challenge
Submissions for the first challenge will close on November 20, 2011. All entries must include a clear, detailed proposal describing an innovative, original breast-cancer detection, diagnosis, or treatment technology or process. Applicants should fill out the submission form (available online at http://challenge.healthymagination.com/health) and be sure to have the following prepared: • A short description for the public (300 words maximum) • Images, video, or other media that help...
Tools for Molecular Diagnostics
The molecular diagnostics industry is growing rapidly, thanks to the inherent accuracy, sensitivity, specificity, and quick turnaround of molecular techniques. In addition, because of the accuracy, sensitivity, and specificity, laboratories can obtain valid results from very small amounts of specimen. This is useful for the forensic area, but also for detecting very low concentrations of target material, enabling clinicians to detect disease at a very early stage. As a result, a growing number...
Technological and Regulatory Developments in Point of Care
Point-of-care testing is present---in varying degrees---in every hospital in the United States. Blood-glucose tests, pregnancy tests, and radiology-related tests, for example, are commonplace and virtually indispensible. Molecular diagnostics for infectious-disease testing are becoming more widespread as well. With all of these technological advances come greater and more complicated regulatory scrutiny. FDA, CMS, and CDC are all keeping watchful eyes on the point-of-care testing market. To...
Goldman Sachs initiates coverage of IVD companies
Investment banking firm Goldman Sachs (New York) has initiated coverage on the following six IVD companies: Alere, Cepheid, Gen-Probe, Hologic, Myriad Genetics, and Qiagen. In an equity research report, Goldman Sachs analysts discussed various factors that will affect the IVD industry both positively and negatively. According to the analysts, one of the factors that will contribute positively is the transition to molecular testing. “Advances in knowledge around the genetic underpinnings...
Cepheid earns WHO endorsement of rapid TB test
Cepheid’s Xpert MTB/RIF test won the endorsement of the World Health Organization (WHO) last December. The test has the potential to revolutionize TB care and treatment by accurately diagnosing patients in about 100 minutes—a huge reduction in time to results compared to conventional TB diagnosis, a WHO representative said in a press statement. Cepheid (Sunnyvale, CA) is offering a 75% discount on the price of the test and the table-top computer system that goes with it to...
Aetna supports study on genetic tests
Significant questions have been raised among doctors and public health agencies about whether genetic tests are being offered to the women who can most benefit and whether the information from the tests is being put to best use. Insurance company Aetna Inc. (Hartford, CT) is funding a landmark study that will explore patterns of how and for what groups of women the available genetic tests for BRCA1 and BRCA2 mutations are being used in the community healthcare setting. This study will also look...
GE Acquires Clarient: In vivo meets in vitro
GE Healthcare purchased Clarient Inc. (Aliso Viejo, CA) late last year. The acquisition was announced in October; U.S. regulators approved the transaction the following month.  GE, a well-known player in diagnostic imaging, is looking to lengthen its reach into molecular diagnostics (MDx), particularly in the oncology realm. With its acquisition of Clarient, it gains the potential for playing a large, comprehensive role in diagnosing and treating cancer. “Clarient is a clear leader...