Danish diagnostic firm Bioporto announced on Friday that its test for acute kidney injury in hospitalized children has received clearance from the US Food and Drug Administration.

Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its QScout™ rapid-result hematology system, which provides fast, point-of-care white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates the number and percent of five types of mature WBCs as well as immature granulocytes.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearances from the U.S. Federal Drug Administration (FDA) for a novel blood collection device that obtains blood samples from a fingerstick that produce lab-quality results for some of the most commonly ordered blood tests.

First Light Diagnostics announced that the US Food and Drug Administration (FDA) has cleared its SensiTox® B. anthracis Toxin Test to be marketed in the U.S.

DiaCarta announced on Tuesday that its over-the-counter fecal occult blood test has received 510(k) clearance from the US Food and Drug Administration.

Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant) which has been contemporaneously approved for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

The US Food and Drug Administration said Thursday that it has granted Roche Emergency Use Authorization for a new version of its multiplex molecular assay for detecting SARS-CoV-2 and influenza A/B.

The US Food and Drug Administration (FDA) has approved LetsGetChecked’s at-home testing system for chlamydia and gonorrhoea.

Agilent Technologies on Tuesday said it gained US Food and Drug Administration approval of the firm's PD-L1 companion diagnostic assay for use in identifying gastric or gastroesophageal junction adenocarcinoma patients for a combination treatment with Merck's Keytruda (pembrolizumab) checkpoint inhibitor.

Roche announced on Tuesday that its Cobas HPV test has received approval from the US Food and Drug Administration for use on the Cobas 5800 instrument.