The firm said that the shortage of testing in rural America highlights a need for its rapid molecular system, which is small enough to fit in a backpack.
The company said that in response to the letter, it is recalling all non-Luminex temperature verification fixtures from the field for its Verigene SP instrument.
Sepset said its early test for sepsis, a condition that requires rapid diagnosis and treatment, would give clinicians valuable time to identify treatment strategies.
Yale researchers said that they anticipate their RNA extraction-free saliva assay will make testing more scalable, affordable, and available to the public.
Clinicians at Addenbrooke's Hospital in the UK are seeing reduced time to result and additional clinical benefits from using the DRW SAMBA II SARS-CoV-2 assay.
The startup is developing a qPCR-based profiling method that could provide results within hours to clinicians treating their cancer patients with immune checkpoint inhibitors.
The group believes its assay, which detects HPV-16 DNA, could be deployed as a screening test in the way that HPV is currently screened to prevent cervical cancer.
DNAe said its semiconductor-based platform has potential to detect a broader variety of pathogens and resistance genes than current molecular technologies.
