The US Food and Drug Administration (FDA) has released a long-sought final guidance document on in vitro diagnostic (IVD) companion diagnostic (CDx) products—products intended to help guide the therapeutic use of new medicines based on a consumer's genetic characteristics. Background Regulators and industry have both been touting the benefits of companion diagnostics in recent years as the products have become, in the words of FDA, "more common." The benefits to both ...

The term "clinical utility" has come into increasingly common usage as healthcare stakeholders direct greater attention to the determination and establishment of the value of healthcare services, interventions and technologies. The meaning differs somewhat among the various stakeholders depending on their roles and interests. For example, one Medicare contractor (Palmetto) describes its requirement for evidence of clinical utility as "demonstrates change in physician trea...

US regulators on Tuesday announced the approval of the US' first companion diagnostic test to detect a gene mutation associated with a type of lung cancer, giving lung cancer patients a similar diagnostic tool now available to patients with breast cancer. Background The product, approved 14 May 2013, is known as the Cobas EGFR Mutation Test, and acts as a companion diagnostic test to the already-approved cancer drug Tarceva. The drug's manufacturer, Astellas, wrote in a...

The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has agreed to recommend the use of an innovative new diagnostic test designed to guide the use of chemotherapy in patients with early breast cancer. Specifically, the recommendation covers the use of Oncotype DX in patients in the early stages of oestrogen receptor positive (ER+), lymph node negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-) breast...

A new untitled letter sent by US regulators to an Internet domain hosting company alleges that the company marketed an unapproved diagnostic test capable of testing for HIV, thereby violating federal law. Background HIV diagnostic kits were only recently approved for over-the-counter (OTC) sales. In July 2012, the US Food and Drug Administration (FDA) approved OraSure's In-Home OraQuick HIV test after its Blood Products Advisory Committee overwhelmingly supported its ...

The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...

A study by Johns Hopkins researchers claim medical mistakes in the intensive care unit (ICU) kill as many as 40,500 patents per year, as many deaths as breast cancer patients suffer. The researchers examined more than 5,800 autopsy reports from various ICUs. The study said not all missed errors contributed directly to patient death, but that patients in ICU were twice as likely to suffer a fatal misdiagnosis. "Our study shows that misdiagnosis is alarmingly common in th...

A companion diagnostic test developed by Manchester, England-based QIAGEN and marketed by Bristol-Myers Squibb and Eli Lilly and Company has won approval from the US Food and Drug Administration (FDA) for determining whether the anti-colorectal cancer (CRC) drug Erbitux (cetuximab) will be effective in patients. The product, known as the Therascreen KRAS RSQ PCR Kit, screens patients for the presence or absence of a particular mutation in the KRAS gene. If the KRAS gene ...

A long-standing and popular diagnostic test used by physicians to screen patients for cognitive ailments is being subjected to copyright claims that threaten to restrict the use of the test and others like it. Writing in the New England Journal of Medicine (NEJM), John C. Newman, PhD and Robin Feldman, JD describe the saga of the Mini-Mental State Examination (MMSE).  First published in 1975, the 30-question test grew in to a ubiquitous presence thanks to lax co...