Announcements

ChromaCode’s Emergency Use Authorization (EUA) Expanded by FDA for High-Throughput HDPCR™ SARS-CoV-2 Real-Time PCR Assay

03/03/2022

Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–ChromaCode, Inc., a company redefining molecular testing through data science, announced today that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates, which has the potential to more than…

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Published Study Details Proof-of-Concept for COVID-19 Detection via Saliva Screening

03/02/2022

Methodology developed by QIMR Berghofer researchers utilizing the Agilent Cary 630 FTIR Spectrometer Excerpt from the Press Release: Agilent Technologies Inc. (NYSE: A) announced today that researchers from the QIMR Berghofer Medical Research Institute in Brisbane, Australia, collaborated with Agilent experts on a proof-of-concept FTIR-based saliva COVID-19 testing workflow using the Agilent Cary 630 FTIR Spectrometer. The study…

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Naveris’ Head and Neck Cancer Recurrence Detection Study Selected for Presentation at ASTRO 2022 Plenary Session

03/02/2022

Excerpt from the Press Release: NATICK, Mass.–(BUSINESS WIRE)–Naveris, Inc., a leader in molecular diagnostics for viral cancers, today announced the presentation of significant new data at the plenary session of the ASTRO 2022 Multidisciplinary Head and Neck Cancers Symposium supporting the clinical value of its flagship diagnostic test, NavDx®. In a real-world analysis of 1,076…

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Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma

03/02/2022

Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma If approved by the European Medicines Agency, KIMMTRAK will be the first and only treatment option approved in Europe to treat patients with unresectable or metastatic uveal melanoma KIMMTRAK demonstrated statistically and clinically meaningful overall survival (OS) benefit, hazard ratio of 0.51, with median OS of almost 22 months Excerpt from the…

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Merlin Test reduces unnecessary surgeries and associated complications for melanoma patients

03/01/2022

Excerpt from the Press Release: ROTTERDAM, Netherlands and SAN DIEGO, Feb. 24, 2022 /PRNewswire/ — Today, SkylineDx announced that their Merlin Test for melanoma patients would have been able to reduce over 59% of surgery-related complications by means of deselecting patients for surgery [2]. The commercially available Merlin Test identifies melanoma patients that can safely forgo a sentinel lymph node…

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EPIC SCIENCES AND FULGENT GENETICS COLLABORATE TO DELIVER DefineMBC™ RESULTS FOR METASTATIC BREAST CANCER PATIENTS

03/01/2022

Epic Sciences scales its workflow for ctDNA testing with Next Generation Sequencing Leader Fulgent Fulgent Genetics’ expertise in high-volume testing powers Epic’s Comprehensive Cancer Profiling Excerpt from the Press Release: SAN DIEGO, Feb. 24, 2022 /PRNewswire/ –Epic Sciences, Inc. today announced it has partnered with Fulgent Genetics (NASDAQ:FLGT) to deliver DefineMBC comprehensive profiling results for metastatic breast…

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Pliant Therapeutics Announces Positive DSMB Safety Review and Commencement of Enrollment of Phase 2a Trial of PLN-74809 at 320 mg Dose in Idiopathic Pulmonary Fibrosis

03/01/2022

Recent independent Data Safety Monitoring Board (DSMB) review recommended the INTEGRIS-IPF Phase 2a trial continue without modification and proceed to evaluate dosing at 320mg Trial initiation follows the FDA authorization of evaluation of long-term dosing of PLN-74809 at doses up to 320 mg in IPF patients Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Feb.…

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Ra Medical Systems Provides an Update on Enrollment in Its Pivotal Atherectomy Clinical Trial

02/28/2022

Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focused on developing its excimer laser system to treat vascular diseases, announces enrollment has reached 95 subjects in its pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy…

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Long-Term Follow-Up Data Reinforce Continued Overall Survival Benefit of BAVENCIO® (avelumab) First-Line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma

02/28/2022

38-month median follow-up data from the Phase III JAVELIN Bladder 100 trial demonstrated prolonged median OS of 23.8 months with BAVENCIO plus best supportive care (BSC) in the first-line maintenance setting versus a median OS of 15.0 months with BSC alone BAVENCIO continues to be the first and only immunotherapy to improve survival in the…

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Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis

02/28/2022

The percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142 Zeposia is the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved to treat patients with ulcerative colitis Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced interim results from the…

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