Navigenics has added a new medications feature to its service offerings and is providing customers with a wallet-sized report that contains a condensed version of the genetic response to as many as 12 prescription drugs, which the company began reporting as part of its DTC service this week.
The company will use the cash to continue developing in vitro diagnostic assays for its "chemistry and reagent device," or CARD — which integrates sample preparation, nucleic acid amplification, and endpoint detection all on a single microfluidics-based, point-of-care polymeric module.
After missing the first-to-market opportunities with KRAS, both Merck KGaA and Amgen are strategically looking into additional gene markers, with the likely aim of being able to launch companion tests to their drugs that are more sensitive and accurate than the competition.
CAP and ASCO issued new guidelines to improve accuracy of immunohistochemistry-based ER and PgR testing in breast cancer. The groups estimate that between 10 percent and 20 percent of IHC test results throughout the world may be inaccurate, yielding false-positive or false-negative results.
Ahead of a cost-effectiveness appraisal by UK's NICE, AstraZeneca is paying for EGFR mutation testing for non-small cell lung cancer patients to determine if they will benefit from treatment with Iressa. The genetic testing program is part of a patient access scheme the company has agreed to with the National Health Service to provide more granularity about the cost and value of the treatment.
According to the agency, ParagonDx's ASR probes for gauging the presence of CYP2C9*2, CYP2C9*3, VKORC1 1173, VKORC1 3730 variants "are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body."
The FDA's Oncologic Drugs Advisory Committee this week voted in favor of requiring ChemGenex to submit "a well characterized" in vitro diagnostic to identify patients with T315I mutations prior to the approval of Omapro.
The study found that hospitalization rates for heart patients taking warfarin dropped by approximately 30 percent when genetic information was available to doctors, but a reviewer noted that the study did not sufficiently account for the fact that physicians may have managed their genotyped patients more closely, leading to better outcomes.
The boxed warning for Plavix's label alerts doctors that genetic tests are available to establish patients' CYP2C19 status. However, the FDA leaves it up to physicians to decide whether to wait for genetic testing results or put patients on an alternative treatment.
The study showed that alterations in the ABCB1 gene had no link to increased bleeding in patients treated with either Plavix or its competitor Effient, though patients treated with Plavix who were homozygous for a particular allele had an increased risk of cardiovascular death, heart attack, or stroke.
Research presented at the American College of Cardiology scientific session in Atlanta today suggests individuals who receive genetic testing early in their warfarin treatment are up to 31 percent less likely to be hospitalized than those who don't.
GSK is conducting a Phase III study for a MAGE-A3-targeting therapeutic for the adjuvant treatment of melanoma. To receive the drug in the study, participants' tumors must be shown to express MAGE-A3 via a molecular test that Abbott is developing.