The FDA, the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services in the USA have formed an interagency task force with the goal of facilitating rapid development and deployment of in vitro diagnostic tests during public health emergencies.
Sight Diagnostics received the CE Mark last year for its OLO system, which uses digital microscopy to visually analyze cell types by size, shape, count and morphology, from a few drops of blood during a single office visit. The technology has been used to screen over 600,000 samples for malaria infections and will now be adding complete blood count testing to its system. Sight Diagnostics has raised US$27.8 million to continue its global commercial expansion, fund regulatory efforts and support its research and development.
Magnolia Medical Technologies’ Steripath Gen2 Initial Specimen Diversion Device aims to reduce sample contamination during patient blood draws, which lead to inaccurate laboratory test results. The company has raised US$20 million in venture capital funding to help scale up production.
In 2018, the FDA achieved a new record of approving 106 new devices.
The FDA also outlined the latest steps in its plan to strengthen the 510(k) clearance program, including a new final guidance for moderate-risk devices to use a separate set of criteria in their demonstrations of substantial equivalence to already-marketed devices.
Tyto Care makes telehealth equipment for at-home doctor’s exams. These hand-held, modular tools are used to examine the heart, lungs, skin, ears, throat, abdomen, and body temperature, and sends the information remotely to a clinician. Tyto Care has raised an additional US$9 million, bringing its Series C round to a total of US$33.5 million. The company plans to use the funds to expand into remote and rural communities in the USA, Europe, Japan and China through strategic partnerships.
Proteus Digital Health has launched an oral chemotherapy equipped with its ingestible sensor. The digital pill will be used to treat stage 3 and 4 colorecal cancer patients with capecitabine, and provide feedback to physicians by reporting the time, dose, and type of chemotherapy taken. This gives physicians a better opportunity to intervene if patients are not taking their medication correctly or miss a dose.
CellMax Life’s CMx platform filters out and counts precancer and cancer cells in the bloodstream. It’s FirstSightCRC test was able to detect the small, precancerous colon polyps known as adenomas with close to 90% accuracy. The increases in cell counts also correlates with increases in disease severity. This is a highly sensitive noninvasive testing option for precancer instead of a colonoscopy.
Contextual Genomics provides assays for detecting genomic mutations in blood and solid tumours. It has released a new version of its Find It solid tumour panel, while its new Follow It panel screens for the same mutations in cell-free circulating tumour DNA found in blood plasma. Follow It can be used to monitor tumour burden, treatment resistance and disease progression.
The FDA has finalized its new device guidance program: the Safer Technologies Program (STeP). It assess products that may not meet the high criteria for the Breakthrough Devices Program, but that would still offer significant benefits in safety compared to current devices or diagnostics. Other documents expected in 2019 include the final guidance on the 510(k) program.
Liquid biopsy company, Seer, has received $36 million in funding to develop early-warning tests for cancer and neurological diseases. It uses nanotechnology, protein chemistry and machine learning algorithms to profile a broad array of the body’s proteins and generate insights into the progression of diseases at the population level. Seer hopes to collaborate with industry partners to develop new products using this system.