Technology & Devices

Natera Announces SMART Study Data for Aneuploidy and 22q Unblinded

SAN CARLOS, Calif., Sept. 2, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and leader in cell-free DNA testing, today announced the unblinding of the SMART clinical trial data, and the validation of an artificial intelligence-based (AI) platform as part of its Panorama non-invasive prenatal test (NIPT). Panorama with …

Read More »

Roche Receives FDA Approval for First HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the Fight Against HIV/AIDS

Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. The test provides healthcare professionals with a single result to confirm HIV …

Read More »

Leo Pharma and Elektrofi Enter Exclusive License Agreement to Develop Monoclonal Antibodies Using Elektrofi’s High-Concentration, Low-Volume Delivery Technology

BOSTON & BALLERUP, Denmark–(BUSINESS WIRE)–Elektrofi, Inc., a Boston-based biotechnology company focused on drug formulation and delivery innovations, and LEO Pharma A/S, a global leader in medical dermatology, today announced an exclusive license agreement to develop subcutaneously administered antibodies using Elektrofi’s high-concentration, low-volume delivery technology. Under the terms of the agreement, …

Read More »

FDA Approves Foundation Medicine’s FoundationOne Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®Liquid CDx, the Company’s comprehensive pan-tumor liquid biopsy test. FoundationOne Liquid CDx will be commercially available on Friday, August 28 and is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in …

Read More »

Natera Partners with Massachusetts General Hospital for a Prospective Randomized Clinical Trial in Early Stage Breast Cancer

SAN CARLOS, Calif., Aug. 27, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, today announced a collaborative agreement with Mass General Cancer Center (MGCC) of Massachusetts General Hospital, related to an investigator-initiated multi-center, Phase II randomized clinical trial of Ribociclib (Kisqali®), a CDK4/6 inhibitor, for the …

Read More »

FDA Grants Emergency Use Authorization to Abbott’s Fast, $5, 15-Minute Easy-to-Use COVID-19 Antigen Test

ABBOTT PARK, Ill., Aug. 26, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit …

Read More »

Fluidigm Granted FDA Emergency Use Authorization for Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay for COVID-19

SOUTH SAN FRANCISCO, Calif., Aug. 25, 2020 (GLOBE NEWSWIRE) — Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Advanta™ Dx SARS-CoV-2 RT-PCR …

Read More »

Guardant Health Receives FDA Emergency Use Authorization for its Guardant-19 Next Generation Sequencing-Based COVID-19 Test

REDWOOD CITY, Calif., Aug. 24, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has granted the Guardant-19 test emergency use authorization (EUA) for use in the detection of the novel coronavirus, SARS-CoV-2. The test is being offered to Guardant Health employees …

Read More »

AbCellera Acquires OrthoMab Bispecific Platform to Propel the Development of Antibody Therapies for Pharma and Biotech Partners

VANCOUVER, British Columbia–(BUSINESS WIRE)–AbCellera today announced the acquisition of the OrthoMab bispecific platform from Dualogics, LLC. (Dualogics). OrthoMab is a clinically validated platform that uses the most advanced computational and experimental protein engineering methods to create IgG-like bispecific antibodies from any two antibody sequences. By integrating OrthoMab into its existing technology …

Read More »

Thermo Fisher Scientific Signs Oncology Companion Diagnostic Agreement with Hengrui Therapeutics

CARLSBAD, Calif., Aug. 17, 2020 /PRNewswire/ — Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Hengrui Therapeutics, Inc. (HTI), a U.S. subsidiary of Chinese pharmaceutical company Jiangsu Hengrui Medicine Co., Ltd. (JHM), to develop a CDx that will leverage the Oncomine Precision Assay, which runs on the …

Read More »