Close Menu

Vela Diagnostics

In the quarter, the firm submitted two assays for 510(k) approval and increased its customer base and adoption of its Group B Strep assay.

Nasdaq told the company that it fails to meet requirements calling for a minimum $35 million market value of listed securities and a $1 minimum bid price on its shares.

The molecular diagnostic test detects Shiga toxin-producing E. coli and the serotype O157 directly from a patient specimen. 

The molecular diagnostics firm has retained Roth Capital Partners as financial advisor to assist in restructuring Series C Warrants issued in March.

If approved, the multiplex Staph panel will grow the firm's menu of assays on its molecular platform to three.

During the quarter the firm received 510(k) clearance from the US Food and Drug Administration for its Group B Strep test.  

The partners will develop a multiplexed nucleic acid-based assay to detect carbapenem-resistant Enterobacteriaceae from whole blood samples.

The molecular diagnostics firm also received FDA clearance for a strep test and began clinical trials for an E. coli assay in the quarter.

The Group B Strep test is the second test on the firm's menu granted clearance, and is intended for screening pregnant women. 

The firm, which went public in October, made a public offering of more than 2.5 million units at $8.80 per unit. 

Pages

Public health experts call for a transparent COVID-19 vaccine approval process in a letter; the Food and Drug Administration commissioner assures science-based approval.

The Verge reports that new gene-naming guidelines aim in part to avoid Excel-related name change confusion.

In Nature this week: tuatara genome sequence aids in understanding amniote evolution, and more.

According to the Guardian, UK virologists say in a letter to officials that their expertise has been pushed aside in COVID-19 response plans.