The tests are designed to monitor a patient's immune system for cancer responses rather than looking for tumor cells or specific biomarkers.
The firm said the clearance authorizes use of its smartphone-based albumin-to-creatinine ratio test by healthcare professionals at the point of care.
The diagnostics company announced it has entered a memorandum of understanding with Orot[+] to expand distribution of Todos' blood tests into Japan.
The appointment of a former Roche executive as the firm's new COO is viewed as a significant event for a firm still in the early stages of driving adoption of its Pheno system.
The company will market Inivata's InVision liquid biopsy assays to insured and self-pay patients across the region.
Israel-based software company Medial EarlySign will work with Geisinger's innovation center to develop technologies to predict lower GI and other "high-burden" diseases.
Using a fingerstick, the Mylan HIV Self Test can be completed at home and detects whether HIV antibodies are present in about 15 minutes.
Variantyx, a 2014 spinout from Tel Aviv University that is based in Framingham, Massachusetts, provides clinical genomic testing for screening and rare disease diagnostics.
Baylor Genetics will be King Faisal Specialist Hospital International's exclusive lab partner for all genetic testing and precision medicine applications.
CEO Yoel Ezra said the firm plans to deploy a prototype in pilot studies next year, and is eyeing opportunities in the US, Europe, India, and the Middle East.