News

• NeuMoDx CT/NG Assay designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the U.S.

• U.S. regulatory clearance of new assay for use on both NeuMoDx 96 and 288 versions of integrated PCR-based clinical molecular testing system

• Global presence anchored by 16 EU-certified in-vitro diagnostics (CE-IVD) tests, positioning NeuMoDx as having one of the broadest test menus available to customers

Germantown, Maryland, and Venlo, the Netherlands, Jan. 08, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.

This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the U.S. National Institutes of Health. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, the time it takes for results to be received is often long, impeding follow-up care.

Thomas (Tommy) Luginbill has accepted the position of executive director of the Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC). PIC MC is part of Montgomery College’s efforts to grow a hub of education, business, and entrepreneurship, where industry partners co-locate and actively interact with faculty and students to achieve both educational and economic success. In this capacity, Luginbill will continue to advance the development of this innovative science and technology hub in collaboration with academic, corporate and government partners. 

“I am honored to follow in the footsteps of those who have paved the way before me at PIC MC. Their dedication and hard work have laid the foundation for our mission,” Luginbill said. “We are committed to building upon this legacy, creating a vibrant hub for education, business, and innovation that will continue to thrive and benefit the Montgomery County community. Together with our partners, we are ready to embrace this challenge and honor the past while shaping the future.”

Board appointees represent expertise of Maryland’s academic research institutions

COLUMBIA, Md., Jan. 4, 2024 /PRNewswire/ — TEDCO, Maryland’s economic engine for technology companies, announced the recent appointment of Christina DeMur, director of technology development at Johns Hopkins Technology Ventures, to the Maryland Innovation Initiative Board of Directors.

The Maryland Innovation Initiative (MII) was created as a collaboration between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University (JHU); Morgan State University (MSU); University of Maryland, College Park (UMCP); University of Maryland, Baltimore (UMB); University of Maryland, Baltimore County (UMBC).

Recently this collaboration has expanded to include two more comprehensive universities – Frostburg State University and Bowie State University. This expansion will allow MII to further its reach and help bring more innovative research to the market.

ROCKVILLE, Md., Jan. 4, 2024 /PRNewswire/ — MaximBio, a leading Maryland-based manufacturer specializing in lateral flow and diagnostic devices, is announcing the receipt of a $49.5 million award from the U.S. Department of Health and Human Services (HHS) through the Administration for Strategic Preparedness and Response (ASPR). This funding is designated to fortify the domestic manufacturing capabilities for diagnostic tests and enhance preparedness for potential future pandemics. The award is part of a broader initiative awarding $600 million to 12 domestic COVID-19 test manufacturers.

Project NextGen is a $5 billion initiative to develop next-generation medical countermeasures, including vaccines and therapeutics, to enhance preparedness for future COVID-19 strains and variants.

MANASSAS, Va.–(BUSINESS WIRE)–ATCC, the world’s premier biological materials management and standards organization, today announced a five-year, $87 million award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of next-generation medical countermeasures (MCMs) to protect Americans from public health security threats such as coronaviruses.

Lion TCR to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to develop and scale TCR-T cell therapies for solid tumors and viral-related diseases.

ROCKVILLE, Md. and SINGAPORE, Jan. 03, 2024 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and innovative bioprocessing applications, and Lion TCR, an Asia-based, clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-T cell therapies for solid tumors and life-threatening viral infections today announced the signing of a strategic platform license (SPL). This partnership will enhance MaxCyte’s presence in Asia, with anticipated expansion into the US and European markets.

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced positive initial safety, tolerability, and pharmacokinetic results from a Phase 1a study of GMI-1687 in healthy volunteers.

There’s a lot of talk about artificial intelligence, or AI, these days. AI is everywhere—from virtual assistants to facial recognition software. The technology is even assisting doctors and scientists. So what exactly is AI? And how is it helping advance scientific research?

“AI is basically trying to teach computers to ‘think’ in the same way as the human brain,” says Dr. Despina Kontos, an AI researcher at Columbia University.

One approach to AI uses a process called machine learning. In machine learning, a computer model is built to predict what may happen in the real world. The model is taught to analyze and recognize patterns in a data set. This training enables the model to then make predictions about new data. Some AI programs can also teach themselves to ask new questions and make novel connections between pieces of information.

Maryland biotechnology company promotes improved patient outcomes for infants with body deformities

COLUMBIA, Md. (January 3, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 investment from its Life Science Investment Fund (LSIF) into PediaMetrix, a biotechnology company working to detect body deformities in infants and improve patient outcomes. TEDCO’s LSIF lives under the Seed Funds umbrella and invests in companies that have a Federal Drug Administration (FDA) pathway. Participating in this round were also Blu Ventures, as well as a pediatrician.

FDA IDE approval of Sonavex’s randomized trial comes months after meeting the endpoint of its first clinical study

BALTIMORE, Jan. 2, 2024 /PRNewswire-PRWeb/ — Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).