FDA clears technology to distinguish bacterial and viral infections
October 2021—The Food and Drug Administration granted 510(k) clearance for use of the MeMed BV test on the point-of-need platform MeMed Key to help providers distinguish between bacterial and viral infections. The technology has been cleared for children and adults.
Clearance was based on a multicenter blinded clinical validation study enrolling more than 1,000 children and adults and addresses goals laid out in the U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria. The company says the test provides highly accurate results with area under the curve of 90 percent and 97 percent (primary and secondary endpoints). MeMed, of Haifa, Israel, has established its U.S. base in Boston and is ramping up commercial activities to ensure broad availability of its products across the United States.
MeMed BV is an immune-based protein signature test. It measures and computationally integrates the levels of three immune system proteins: TRAIL, IP-10, and CRP. When run on the MeMed Key platform, MeMed BV provides a result within 15 minutes.
MeMed Key is a platform that enables highly sensitive measurements of multiple proteins within minutes at the point of need. The MeMed Key development program has been partially funded by the U.S. Department of Defense and the EU Commission.
FDA grants clearance and CLIA waiver for PCR STI test
Visby Medical received FDA 510(k) clearance and was granted a waiver under CLIA ’88 to market its single-use PCR diagnostic test for the multiplexed detection of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.
The test uses a self-collected vaginal swab and offers PCR technology in palm-sized dimensions. The company says accurate results are provided in under 30 minutes, with no additional instruments required.
Roche opens access to pathology imaging tools
Roche introduced the Roche Digital Pathology Open Environment, which allows software developers to easily integrate their image analysis tools for tumor tissue with Roche’s uPath enterprise software, an application for pathologist workflow.
The open environment allows for the secure exchange and flow of data so that pathologists can access advanced algorithms from third parties alongside Roche’s menu of artificial-intelligence–based image analysis tools. This enables software developers worldwide to distribute their digital products through Roche’s uPath software, offering a broader set of diagnostic tools for pathologists.
FDA OKs CDx for previously treated IDH1-mutated CCA
The Food and Drug Administration granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for Servier Pharmaceuticals’ Tibsovo (ivosidenib tablets).
Tibsovo is an IDH1 inhibitor that is approved for the treatment of adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test.
Tibsovo is approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutated relapsed or refractory AML and for adults with newly diagnosed IDH1-mutated AML who are age 75 or older or who have comorbidities that preclude the use of intensive induction chemotherapy. The approval of Tibsovo in previously treated IDH1-mutated CCA is supported by data from the ClarIDHy study, the first and only randomized phase three trial for previously treated IDH1-mutated CCA.
Seegene unveils molecular testing system
Seegene unveiled its fully automated molecular testing system, STARlet-AIOS, at the AACC annual meeting in September.
The system is composed of independent and detachable modules along with the company’s proprietary SW architecture. It is designed with an extraction/liquid handler and PCR instrument that are integrated with an in-house–developed robotic arm module. Seegene says laboratories can purchase the full package AIOS system or integrate their existing instruments on site if they already have Seegene’s liquid handler and real-time PCR instrument.