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The mass spec-based panel using 26 protein biomarkers is being developed to detect heart failure earlier than with existing BNP-only-based tests.
Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.
The guidelines provide recommendations for what CYP2C9 variant alleles should be included in clinical pharmacogenomic tests assessing that gene.
The researchers said such a screening approach could capture younger individuals who don't regularly visit medical professionals.
A Roche executive said he expects essentially all the firm's US troponin customers will convert to the high-sensitivity assay over the next two to three years.
The facility will be mass spec-focused and comprise a service contract lab for developing protein tests and a CAP- and CLIA-certified lab for offering them.
The company's new strategic direction recognizes that the incorporation of genomics into patients' lives requires engaging other players in the complex healthcare ecosystem.
Researchers reported that elevated high-sensitivity troponin I is strongly associated with increased risk of cardiovascular disease in some populations.
The test can be used to rapidly and accurately identify patients suffering from heart attacks, and to help identify low-risk patients who may be safely discharged, the firm said.
Individuals identified as needing homozygous FH evaluation will receive confirmatory genetic testing from Invitae and genetic counseling from Genome Medical.
The companies today launched four assays for the Chinese market for renal, liver, and cardiac testing for use on the Vitros 4600 and Vitros 5600 systems.
In a hospital setting, 1 in 20 patients had cardiac troponin levels above the cut off for diagnosing a heart attack, including patients with no clinical signs of one.
The Finnish diagnostics company is working to expand US and European sales of its ceramide lipid-based cardiovascular risk assessment assay, CERT.
The partners anticipate developing tests that analyze clusters of biomarkers to detect cardiovascular disease, kidney disease, liver cancer, and other diseases.
Galaxy has licensed IP from Proteome Sciences for the development of a test for the diagnosis and timing of stroke onset to help inform treatment decisions.
The tests are designed to detect genetic variations including SNPs, insertion-deletions, copy number variations, and variations in segmental duplications.
Clinicians need to understand higher-sensitivity troponin assays will detect longer-term cardiac injury as well as acute conditions, experts say.
The mass spectrometry-based tests measure the level of five proteins in patient serum to assess cholesterol efflux capacity and risk of coronary artery disease.
A court in San Diego has stated that part of the suit between Quidel and Beckman is void as a matter of law.
The high-sensitivity test runs on the Quidel Triage Meter Pro instrument and joins a growing list of similar tests that have recently received regulatory approvals.