Framingham, Massachusetts-based Kephera's tests is intended to be used to differentiate neurocysticercosis from other causes of seizures in patients.
The Nexus IB10 is a point-of-care platform that automatically separates plasma from whole blood for analyses with a range of different tests.
The CE mark advances the firm's strategy to develop and commercialize two- to five-minute tests that use fingerprick blood or stool samples, ProciseDx said.
The firm said it will use the funds to advance development of its HostDx immune response gene expression tests for acute infections and sepsis.
The Mycartis spinoff is developing a point-of-care device and its first diagnostic test, which will be a urine-based self-test to check for chlamydia and gonorrhea.
The startup is exploring options with potential partners and plans to bring a urinary tract infection test through regulatory channels in the next two years.
Clinical investigators have used Longhorn Vaccines and Diagnostics' qPCR approach in a study to detect M. tuberculosis DNA in the mouths of people at high risk for subclinical TB.
Developers pointed to some success, but they also noted that more at-home tests need to demonstrate higher levels of performance and affordability.
The firm is developing a point-of-need blood test that it anticipates launching as an additional option in the market for active TB screening.
New funding may help improve stalled HIV interventions, in part, by spurring on diagnostic testing access and initiatives.
The UK firm has purchased the assets for Enigma Diagnostics and anticipates it will soon receive clearance to market its first test for TB in China.
The multiplexed paper-based assay could rapidly diagnose early-stage Lyme disease more accurately and at a lower cost than existing methods.
The firm is performing a clinical trial for Finder in preparation of a 510(k) submission to the FDA, anticipated in early 2020, it said.
The firm said it is turbocharging the lateral flow format with sensitivity and cost suitable for over-the-counter STI testing.
On the heels of receiving CE marking, the firm is engaging with global distributors and preparing a submission to the FDA for US clearance.
The firm said that after its device is placed on the upper arm, blood collection usually takes between two and three minutes following the press of a button.
The firms noted that QuantuMDx’s Capture-XT technology will enable downstream drug-susceptibility analysis, PCR, NGS, and, with this collaboration, nanopore detection.
The method detects dengue virus from blood serum or plasma using DNA nanostructures and aptamers and can potentially be read with a portable fluoroscope.
Spartan's test is for the rapid, near-patient determination of a cardiac patient's genotype for aid in determining appropriate antiplatelet treatment.
Initiatives to develop commercial breath diagnostic systems reveal that developers are trying out lab-based mass spec systems and portable electronic noses.