NEW YORK – Thermo Fisher Scientific said this week that it is now offering an IVDR version of its Applied Biosystems QuantStudio 5 Dx Real-Time PCR system that meets the requirements of the European Union's new In Vitro Diagnostic Regulation and will help molecular diagnostic kit manufacturers develop IVDR-compliant tests and clinical labs switch to IVDR qPCR testing. Among other updates, the system's multi-mode software is now IVDR compliant, Thermo Fisher said. The system is a class A device under the IVDR, which is a self-certified process. It is available in all regions that recognize the CE mark and is listed with the US Food and Drug Administration.
T2 Biosystems said this week that the Nasdaq Hearings Panel has granted its request for an extension until Nov. 1, 2022, to regain compliance with Nasdaq's minimum bid price requirement. As a result, T2 shares must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days by Nov. 1, otherwise shares of T2's common stock will be delisted from Nasdaq. In addition, the panel approved T2's request to transfer the listing of its common stock from the Nasdaq Global Market to the Nasdaq Capital Market tier as of June 13, 2022. The transfer is not expected to have any impact on trading in the company's stock, T2 said.
Israeli diagnostics company MeMed said this week that Maccabi Healthcare Services will be offering the company's MeMed BV test for distinguishing between viral and bacterial infections in all of its urgent care centers throughout Israel. MeMed said that a recent pilot study done by Maccabi found that in 21 percent of cases doctors reached a more accurate diagnosis by using the MeMed BV test, which measures the levels of three immune system proteins to determine whether an infection is caused by a virus or bacteria.
Abbott announced this week that its board of directors declared a quarterly common dividend of $.47 per share, payable Aug. 15 to shareholders of record at the close of business on July 15.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.