Medical Device Daily Washington Writer
The Centers for Disease Control and Prevention (CDC; Atlanta) has issued the first federal government recommendations to foster accuracy and appropriate use of DNA-based genetic tests.
The guidance document, titled "Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions," which is posted on the CDC's website, addresses considerations for clinical and laboratory professionals that are important for achieving patient benefits and avoiding medical mistakes when molecular genetic tests are used, such as ensuring proper test method selection and test performance and appropriate test result reporting, interpretation and use.
The guidance also covers factors to consider before introducing new tests and what qualifications laboratory personnel should have to perform testing.
Molecular genetic testing is one of the most rapidly growing areas of laboratory testing in the U.S., with the number of genetic diseases and conditions for which tests are available tripling from 423 in the past eight years to more than 1,300, officials said.
The CDC noted that the growth of direct-to-consumer testing, which is permitted in 37 states and often done without oversight, has "raised additional concern about the potential misuse of genetic tests."
DNA-based genetic tests are used to help make decisions about patient care, such as whether patients have or may be at risk for a genetic disease such as cystic fibrosis or whether they may be prone to chronic diseases including cancer, diabetes and blood clotting disorders.
"Getting an accurate diagnosis influences a patient's course of treatment and how they deal with a disease or disease threat," the CDC said. "Implementation of the genetic testing guidance can improve accurate diagnoses and ultimately ensure that patients and their doctors can make the best decisions for their health."
NCI awards first bridge awards
The National Cancer Institute's (NCI) Small Business Innovation Research Program (SBIR) awarded the first two Phase II Bridge Awards, a new funding opportunity intended to aid promising cancer therapies and imaging technologies.
Lpath Therapeutics (San Diego), which focuses on lipidomics-based therapeutics, and OptoSonics (Oriental, North Carolina), which develops molecular imaging instrumentation used in the fields of molecular biology, oncology, drug discovery, diagnostics, and therapeutic medicine, received the first two awards.
The Bridge Awards program, first announced last year, more than triples the amount of monies available through the NCI SBIR program.
The Phase II Bridge Awards are designed to help early stage biomedical companies bridge the funding gap known as the "valley of death," which exists between the end of a Phase II SBIR award and the commercialization of the technology.
The Bridge program provides up to $3 million in additional NCI SBIR funding, following a Phase II SBIR award, to help accelerate the commercialization of new products and technologies. By sharing in the risk on these projects, the NCI also is incentivizing third-party investors to invest in these projects much earlier than they typically would.