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In Brief This Week: Thermo Fisher Scientific, BioReference Laboratories, PerkinElmer, and More

NEW YORK – Thermo Fisher Scientific said this week that Israel's health insurance funds are now covering comprehensive molecular profiling for patients with non-small cell lung cancer. Following the decision, local pathology laboratories that have received approval from Israel's Ministry of Health Laboratories Division can now conduct comprehensive NGS-based molecular testing for NSCLC patients at medical centers throughout the country.

So far, Hadassah Medical Center, Rambam Health Care Campus, Sheba Medical Center, Soroka Medical Center, and Maccabi Healthcare Services have received approval to perform testing using assays based on Thermo Fisher's Oncomine Comprehensive Assay Plus. In cases where comprehensive molecular profiling cannot be performed, the Ministry of Health permitted the use of tests that assess up to 100 genes. Six laboratories are already approved to offer broad molecular profiling using Thermo Fisher's Oncomine Dx Target test, which evaluates tumor samples for up to 23 biomarkers associated with NSCLC.

BioReference Laboratories announced this week that it will provide COVID-19 testing for the National Basketball Association’s players, referees, and team and league staff as the season restarts in Orlando, Florida. Under the terms of the agreement, BioReference will provide PCR diagnostics, rapid diagnostics, and antibody testing. BioReference's parent company Opko Health said that testing protocols have been established with infectious disease experts to maintain the safety of players and employees as the league restarts the 2019-2020 season.

PerkinElmer said this week that it expects reported and organic revenues for the second quarter to increase 12 percent year over year, driven by higher-than-expected demand for the firm’s COVID-19 testing products and related technology. It noted that demand for its RT-PCR and serology tests, RNA extractions systems and kits, and automated liquid handling instrumentation was "especially robust." Total coronavirus-related solutions brought in $190 million of revenues during Q2, PerkinElmer said. The Waltham, Massachusetts-based company is scheduled to release its complete Q2 financial results on July 28.

DiaCarta said this week that Mexican regulators have approved the company's QuantiVirus SARS-CoV-2 test for distribution in the country. Mexico's Ministry of Health, through the Institute of Diagnostic and Epidemiological Reference, evaluated the test and granted approval. As a result, Mexican regulators, the Comisión Federal para la Protección contra Riesgos Sanitarios, authorized the test for immediate marketing.

DiaCarta also said that the Indian Council of Medical Research has evaluated the QuantiVirus SARS-CoV-2 test kit and found 100 percent sensitivity and 100 percent specificity without any interference from other respiratory viruses. The test, which uses real-time PCR technology, has been cleared for sale in India, the Richmond, California-based firm said. In April, the US Food and Drug Administration granted Emergency Use Authorization for the test.

Todos Medical said this week that its marketing and distribution partner 3D Medicines has received authorization from the Brazilian Health Surveillance Agency to distribute Todos’ COVID-19 qPCR test kits and Andis extraction systems. Last week Todos announced it had expanded its agreement with 3D Med to include the distribution of COVID-19 tests in numerous markets including Brazil and the US.

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.