diagnostics

CARB-X announced Tuesday an award of up to $3.6 million (plus up to $10.2 million in milestones) to Maryland-based Novel Microdevices to develop a rapid, point-of-care, battery-powered diagnostic for sexually transmitted infections such as chlamydia and gonorrhea.

The test—which will also identify antibiotic resistance—will diagnose infections in about 25 minutes from a vaginal swab or urine sample and require no sample preparation, making it “particularly suited” for LMICs, according…

France’s bioMérieux has secured European CE marking for three fully automated immunoassays for dengue, the company announced Wednesday.

Performed on the company’s Vidas family platforms, the Vidas Dengue NS1 Ag, Anti-Dengue IgM and Anti-Dengue IgG are “cost-effective and suitable for low- and middle-income countries,” according to the press release.

The company plans to add a chikungunya assay to its diagnostic offerings, per the announcement.

South Korea’s Research Investment for Global Health Technology (RIGHT) Fund launched its sixth RFP on Monday: a new Technical Accelerator Award granting up to $440,000 (per project, for up to one year) for “original and innovative concepts” that tackle endemic and emerging infectious diseases in developing countries.

Applicants must include at least one Korean entity. Proposals for vaccines and therapeutics are due by April 9 and for diagnostics and digital health by April 30.

CARB-X published compulsory guidance on Monday to ensure that new antibacterial products brought to market by its funded companies are used responsibly and made available to people in LMICs.

The Stewardship and Access Plan Development Guide—created by the Boston University-led nonprofit and its partners, including the Access to Medicine Foundation, the Gates Foundation, the Global Antibiotic Research and Development Partnership, the Global Antimicrobial Resistance Innovation Fund, and…

Roche announced last week that WHO has awarded prequalification (PQ) status to the HIV-1 and hepatitis C virus tests on its cobas 6800/8800 Systems.

The company’s Global Access Program—launched in 2014—provides special pricing to LMICs for diagnostic tests for HIV, tuberculosis, hepatitis B and C, and HPV.

Mentions:

Roche announced Monday that it will buy California-based GenMark Diagnostics for $1.8 billion in cash.

The Swiss biotech will expand its portfolio with GenMark’s molecular diagnostic tests, including the ePlex Respiratory Pathogen Panel, which simultaneously screens for several bacteria and 21 viruses (including influenza A and B, RSV and SARS-CoV-2). The announcement came days after the U.S. FDA issued a warning about false positives from Roche’s own multivirus diagnostic.

Portland-based Hemex Health announced Monday that its Gazelle Malaria one-minute point-of-care test outperforms current rapid diagnostic tests (RDTs) and is “nearly as accurate” as expert microscopy in detecting P. vivax malaria.

The press release referenced trial results from Brazil published last week in Malaria Journal: compared to optical microscopy, the battery-powered Gazelle test achieved 96.2% sensitivity versus 83.9% sensitivity for RDTs, according to the article. (Both…

The state of the hunt:

Serum Institute of India will export Covishield doses to the United Kingdom.
  COVAX unveiled initial vaccine allocations, and numerous COVAX participants received their first shipments and began administering jabs.
  Bharat Biotech’s Covaxin demonstrated 81% efficacy against symptomatic disease in an interim Phase 3 analysis.

 

Vaccines


Approved or authorized vaccines
  
U.S. regulators completed their signoff…

Inovio announced Monday that its VGX-3100 DNA-based HPV immunotherapy has met primary and secondary endpoints among all evaluable subjects in Phase 3 trials.

Administered using the Pennsylvania-based biotech’s proprietary Cellectra 5PSP “smart device,” VGX-3100 reduced cervical high-grade squamous intraepithelial lesions caused by HPV-16 and HPV-18 and cleared infection in 23.7% of people with endpoint data.

However, those results excluded eight trial subjects with missing…

The state of the hunt:

J&J’s single-dose vaccine scored unanimous endorsement from a U.S. FDA advisory committee, clearing the way for a likely EUA.
  The COVAX Facility made its first shipments, sending vaccine doses to Ghana and Ivory Coast.
  Moderna and Pfizer made progress toward clinical trials of modified, variant-specific vaccines.

 

Vaccines


Approved or authorized vaccines
  
Pfizer/BioNTech shot continues strong showing…