Adaptive Biotechnologies Corp., of Seattle, reported that Palmetto GBA, a Medicare administrative contractor, has established coverage of its Clonoseq assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). Clonoseq is authorized by the U.S. FDA to detect and monitor minimal residual disease in myeloma and ALL using DNA from a patient's bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing Clonoseq testing.
Hologic Inc., of Marlborough, Mass., said the U.S. FDA has cleared the Localizer radiofrequency identification marker for long-term placement. Initially cleared by the FDA in 2017, Localizer is a non-radioactive, radiofrequency localization system designed for precise marking and targeting of lesions in breast-conserving surgery. Localizer was designed to replace the traditional wire-guided localization method, which requires placement of a wire the day of surgery. With this new clearance, Localizer can now be implanted more than 30 days prior to a breast-conserving surgery. The Localizer system is manufactured by Health Beacons Inc. and is exclusively distributed by Hologic.
Imaginab Inc., of Inglewood, Calif., reported the enrollment of the first patient in the phase II clinical trial of its CD8+ T cell imaging agent. The trial will enroll metastatic cancer patients and study the correlation of imaging signals observed using Imaginab's CD8+ T cell Immuno-PET imaging agent, standard-of-care scans and immunohistochemistry analysis of CD8 in biopsied tissues. The trial will also measure changes in CD8+ T cell distribution before and after immuno-oncology therapies. The study is, in part, financially supported by Boehringer Ingelheim.
Teladoc Health Inc., of Purchase, N.Y., launched Teladoc Back Care, a personalized, online back pain treatment program, in the U.S. According to the company, this new addition to the Teladoc Health care continuum allows patients and employers to leverage virtual care to reduce the intensity, frustration and impact of back pain. Participants receive a personalized back care video treatment plan to be completed at their convenience over four to eight weeks that includes safety instruction, coaching, strengthening, decompression, mobility and movement guidance.
Venturemed Group Inc., of Toledo, Ohio, reported enrollment of the first patients in the BELONG Study – BEnefit of arterial vessel preparation by LONGitudinal micro-incisions before drug eluting balloon angioplasty of the superficial femoral artery (SFA) and popliteal arteries (PA). The primary objective of this clinical study is to evaluate lumen patency at 12 months obtained by preparation of vessels with the Flex vessel preparation system prior to conventional endovascular recanalization of the SFA and PA. The Flex system creates long parallel linear micro-incisions in all plaque morphologies to prepare an ideal vessel environment to facilitate drug-coated balloon angioplasty. This prospective, single-arm, non-randomized study will enroll up to 150 patients in Switzerland. Patients will exit from the study at the completion of their 12-month follow-up.