Santa Clara, Calif.-based Agilent Technologies Inc. reported the launch of a real-time reverse transcription (qRT) PCR-based diagnostic kit for the detection of SARS-CoV-2 RNA. The CE-IVD mark is in accordance with the European Union In Vitro Diagnostic Directive 98/79/EC and is available for immediate distribution. Agilent’s kit is intended for the qualitative detection of CDC-recommended1 N1 and N2 targets from SARS-CoV-2 RNA isolated and purified from nasopharyngeal swab specimens.
Avacta Group plc, of Wetherby, U.K., has entered a license agreement with Barcelona-based Biokit SA, a Werfen Company, to incorporate Affimer reagents into a Biokit in-vitro diagnostic (IVD) product. The license agreement follows an extensive evaluation by Biokit of certain Affimer reagents to detect a key analyte. Under the terms of the agreement Biokit has the right to develop, manufacture and commercialize through original equipment manufacturer (OEM) partners a diagnostic immunoassay for this analyte. Avacta will receive royalties on future sales of any products brought to market following completion of product development and regulatory approvals. Financial details of the agreement were not disclosed.
Franklin Lakes, N.J.-based Becton, Dickinson and Co. (BD) reported an agreement with Madison, Wis.-based Imagemover Inc., a software platform that automates and simplifies medical data collection and management, to offer a companion mobile app that enables more streamlined reporting of SARS-CoV-2 antigen testing results performed on the BD Veritor Plus system at everyday testing locations, such as schools and businesses. The Imagemover app is available immediately for BD Veritor Plus system customers.
New York-based Coridea LLC and Deerfield Management Co. LP, of New York, have forged a collaboration, Deerfield Device Design and Development Catalyst, to advance med-tech innovation and accelerate the formation of commercial companies. The incubator aims to launch 10 new companies over the next five years and will provide funding for operating expenses, early idea generation and project and company evaluation. The med-tech incubator hub and startups will be housed in the Cure building in Manhattan.
Diagnos Inc., of Brossard, Quebec, said it is ready to proceed with clinical trials of its stroke predictor, CARA-St, following a successful proof-of-concept study with over 3,000 patients. CARA stands for computer-assisted retinal analysis. CARA-St aims to predict the likelihood of developing stroke based on the microcirculation analysis of the patient’s retinal image.
Redwood City, Calif.-based Gynesonics Inc. said CMS has included ambulatory surgery centers as an approved site of service for transcervical uterine fibroid ablation (TFA), the procedure associated with its Sonata System. The agency also assigned a device-intensive status to TFA, using the 31% default device offset advantage based on the pricing information provided by Gynesonics. Effective immediately, the reimbursement amount for the ASC setting will be $3,632.42 for transcervical uterine fibroid ablation. For Sonata procedures performed in a hospital outpatient setting, ambulatory payment has increased to $6,794.31.
Lutronic Vision Inc., of Billerica, Mass., a wholly owned subsidiary of Lutronic Corp., said it has treated the first early-stage age-related macular degeneration (AMD) patient in its clinical trial evaluating the R:Gen laser. The single-arm, open-label pilot study will enroll approximately 30 early-stage AMD patients who will be treated with R:Gen, which uses selective retina therapy to target retinal pigment epithelium cells. The primary and secondary objectives are to determine the safety and tolerability of R:Gen in subjects with early-stage AMD and to evaluate the progression and severity of AMD after at 24 and 48 weeks post-treatment. Lutronic expects to the complete the trial by the end of 2022, with results available in 2023.
Medical Diagnostic Laboratories LLC, of Hamilton, N.J., released a new line of urology testing, including prostate cancer and renal cancer hereditary genetics. Available through Uroveda Institute of Urogenital Diseases, the testing blends DNA-based molecular testing with traditional pathology and cytology tests to aid in diagnosing or screening for urologic conditions.
Perkinelmer Inc., of Waltham, Mass., reported the launch of two research-use-only solutions for detecting SARS-CoV-2 mutations, Pkamp Variantdetect SARS-CoV-2 RT-PCR Assay and next generation sequencing-based Nextflex Variant-Seq SARS-CoV-2 Kit. Separately, the company said it has completed its acquisition of Oxford Immunotec Global plc, of Abingdon, U.K., for an undisclosed price. Oxford Immunotec produces test kits for latent tuberculosis, including the T-Spot.TB test.
Houston-based Soliton Inc. has initiated a second preclinical study for potential treatment of liver fibrosis using its rapid acoustic pulse (RAP) therapy. The study is intended to confirm the positive findings of the company’s initial animal study, which showed that RAP reduced the effects of induced liver fibrosis seven days following completion of carbon tetrachloride induction by 42%. The RAP is currently U.S. FDA-cleared for short-term improvement in the appearance of cellulite and as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
Raleigh, N.C.-based Uvision360 Inc. said the U.S. FDA has accepted its submission to expand the Luminelle Dtx system portfolio to now include the Luminelle 360° Bx (Biopsy) sheath. The patented Luminell3 360° Bx sheath, combined with the Luminelle Scope, will be the first visually directed endometrial biopsy system not requiring the use of additional instruments, according to the company.