Diagnostics

Quest Diagnostics Inc (NYSE: DGX) expects Q4 sales of $2.74 billion, a decrease of 9% Y/Y, beating the consensus of $2.54 billion. The company noted preliminary Q4 results reflect higher than expected demand for COVID-19 testing services, while base testing volumes remained steady and...

Medtronic Plc (NYSE: MDT) received a warning letter from the FDA highlighting certain concerns related to medical device quality requirements at the Company's diabetes business headquarters. The Company said that the letter focused on inadequacies in risk assessment, complaint...

Applied DNA Sciences Inc (NASDAQ: APDN) reported a more than ninefold Y/Y increase in Q4 FY21 revenues, driven by the rise in clinical laboratory service revenues related to COVID-19 testing. For Q4, the firm reported $3.0 million in revenues, up from $314,000 a year ago, beating the...

On Friday, the FDA published a list of molecular tests for COVID-19 that may be affected by mutations in the omicron variant of concern. The agency's list focuses on coronavirus tests impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher...

President Biden announced that private health insurance plans would soon reimburse people who buy over-the-counter (OTC), at-home rapid tests for COVID-19. What Happened: The move marks one of a series of steps the White House is planning to encourage better detection and prevention...

The FDA has reissued Emergency Use Authorization (EUA) to LumiraDx Ltd's (NASDAQ: LMDX) SARS-CoV-2 RNA STAR Complete, a rapid nucleic acid amplification technology for high sensitivity, high throughput COVID-19 testing. The EUA now includes testing of asymptomatic...

GBS Inc (NASDAQ: GBS) will prepare for clinical trials of its rapid SARS-CoV-2 (COVID-19) Antibody test following the recent successful completion of a clinical validation study. As previously referenced, a clinical validation study was conducted at the Wyss Institute for...

Valneva SE (NASDAQ: VALN) and IDT Biologika have announced their collaboration to produce Valneva's inactivated COVID-19 vaccine candidate VLA2001.  It follows last week's announcement that Valneva signed an Advance Purchase Agreement with the European Commission...

South Africa Health Products Regulatory Authority (SAHPRA) has approved Chembio Diagnostics Inc's (NASDAQ: CEMI) DPP SARS-CoV-2 Antigen test for use at the point of care. The DPP SARS-CoV-2 Antigen test has been designed to detect SARS-CoV-2 antigens in only 20 minutes.  The...

Applied DNA Sciences Inc (NASDAQ: APDN) plans to introduce its Linea 2.0 COVID-19 Assay for the SARS-CoV-2 E and N genes after submitting its validation data to the New York State Department of Health (NYSDOH) in the next few days. The Company also announced that its EUA-authorized...

​​​​​Thermo Fisher Scientific Inc (NYSE: TMO) said that its COVID-19 diagnostic tests can accurately detect the new coronavirus variant Omicron. The Omicron variant has more than 30 mutations in the spike protein alone.  Last week, the World Health Organisation (WHO) classified the...

Qiagen N.V. (NYSE: QGEN) announced that its polymerase chain reaction (PCR) tests remain accurate and effective in detecting COVID-19 infections in light of the emergence of a new variant detected in South Africa. Qiagen has assessed its COVID-19 PCR tests against the genetic...

Chembio Diagnostics Inc (NASDAQ: CEMI) submitted an Emergency Use Authorization (EUA) application to the FDA for the new DPP SARS-CoV-2 Antigen test. The DPP SARS-CoV-2 Antigen test system has been designed to detect COVID-19 antigens in 20 minutes.  See here Benzinga'...

CMS Molecular Diagnostics Services Program (MolDX) has issued a final local coverage determination (LCD) for pan-cancer immunotherapy monitoring using Natera Inc's (NASDAQ: NTRA) Signatera molecular residual disease (MRD) test.  An accompanying Billing and Coding...

The FDA has granted Emergency Use Authorization (EUA) to Talis Biomedical Corporation's (NASDAQ: TLIS) Talis One COVID-19 Test System, a nucleic acid amplification test (NAAT).  The Talis One system enables sample-to-answer molecular testing in less than 30 minutes....