In one of two clearances, Beckman Coulter got the go-ahead to market its Access PCT chemiluminescent immunoassay for measuring levels of procalcitonin.
Apatagen is developing the aptamer-based test to diagnose human carriers of pork tapeworm and prevent neurocysticercosis, which causes adult-onset epilepsy.
A study of the firm's tests to detect bacterial vaginosis, yeast infections, and trichomoniasis, show they can potentially improve treatment for women with vaginitis.
While NanoString will commercialize its nCounter for research use applications, Veracyte will move its current assays onto the platform to reach a global audience.
Initiatives to develop commercial breath diagnostic systems reveal that developers are trying out lab-based mass spec systems and portable electronic noses.
Enzyre said its platform technology, which requires a small volume of blood, is able to measure up to 12 reactions simultaneously with high sensitivity and specificity.
The companies are developing a blood-based assay for differentiating lung cancer from benign disease in patients testing positive in low-dose CT screens.
In the long term, the company is developing a plan to create more tests based on its technology, which digitizes blood samples and turns them into images.
The guidelines place a stronger emphasis on pancreatic cancer risk genes, and broaden testing recommendations for those with Ashkenazi Jewish ancestry.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
