Pacific Toxicology Laboratories has expanded its menu to include fentanyl and its analogues as deaths surge from synthetic opioid overdoses.
The firm said that entry into the market is a logical progression based on its existing position and strength in hematology, an adjacent segment.
The firm said the point-of-care test would help clinicians rapidly decide whether an upper respiratory infection is viral, bacterial, or clinically insignificant.
A recent study has shown that the biomarker used by the test, GDF-15, is a strong predictor of bleeding risk in patients with atrial fibrillation.
A study found that the use of a blood test instead of urine decreased time to diagnosis and improved outcomes associated with missed pregnancy diagnoses.
The firm is now in talks with commercialization and distribution partners to make the test widely available in Europe and other markets that recognize the CE mark.
Following the CE-IVD marking, Bruker launched the two products, the multiplex real-time PCR-based Fungiplex Candida assay and the Micronaut-AM test plate.
The test leverages loop mediated isothermal amplification technology and enables the rapid detection of Neisseria meningitidis directly from cerebrospinal fluid samples.
The company aims to wrap up field trials for the system by the end of this year and will seek European regulatory clearance thereafter.
Since it launched CADscor, which could compete against molecular tests, in the second quarter, Acarix has announced clients in Germany, Denmark, and Sweden.