Hologic Inc. kicked off its fiscal year 2021 with gusto, reporting revenue of $1.61 billion – up 89.3% year over year, or 86.5% on a constant currency basis. Worldwide sales of molecular diagnostics exceeded expectations, jumping 457.6% to $995.3 million as the company ramped up production to meet growing demand for its two SARS-CoV-2 assays that run on the fully automated Panther and Panther Fusion systems.

The SARS-CoV-2 virus has now had ample time to mutate, as reports of the proliferation of multiple variants make clear, and the U.S. FDA’s Tim Stenzel said the agency is now focused on three variants, including one recently reported from Israel. Stenzel said on the latest COVID-19 testing town hall that one of the key concerns regarding existing authorized tests is the potential for loss of sensitivity, a problem the agency hopes to overcome without the use of live virus.

Abbott Laboratories reported 2020 fourth-quarter revenue up 29% year over year to $10.7 billion, outpacing the consensus estimate of $764 million. The positive growth was largely fueled by sales in diagnostics, which surged 111% to $4.35 billion, from $2.10 billion in the prior year period. Net earnings for the period totaled $2.16 billion, or $1.20 per share, up from $1.5 billion, or $.59 per share a year ago. Adjusted earnings per share (EPS) was $1.45, ahead of the Street target of $1.35.

Health care professionals (HCPs) might prefer a new respirator for each shift, but the ongoing shortage has left clinical sites with a need to employ dry heat for filtering facepiece respirator reuse. The U.S. FDA said on a Jan. 26 town hall that it will stick to an established policy that these devices can be processed with dry heat no more than five times, a practice that is likely to stick for the foreseeable future despite that administrators are required to provide fresh units when possible.

In signing an executive order (EO) on strengthening American manufacturing Jan. 25, President Joe Biden made it clear that the order is aimed at more than infrastructure. While Biden’s Build Back Better Recovery Plan calls for investing hundreds of billions of dollars in buying American products and materials to modernize the nation’s infrastructure and increase its competitiveness, “it also means replenishing our stockpiles to enhance our national security,” the president said.

Driving to a laboratory for blood testing may soon be a thing of the past. Babson Diagnostics Inc. just completed a pivotal study of its new system for collecting and analyzing blood from a finger prick at a pharmacy counter. The results indicate that the microsample system provides comparable results to phlebotomist-drawn venipuncture blood samples.

The impetus to provide more Medicare coverage of telehealth may prove irresistible, but the Medicare Payment Advisory Commission (MedPAC) has some reservations, including that telehealth payment rates should not favor companies like Dallas-based Teladoc Health Inc. over bricks-and-mortar clinics. This and other considerations are driving the commission toward a recommendation that a two-year telehealth pilot program would be more appropriate than simply jumping into a quickly broadened world of Medicare telehealth coverage.

Brain Scientific Inc., a neurology-focused device and software company, is seeking to combine a miniaturized electroencephalogram (EEG) with subcutaneous graphene electrodes to produce a minimally invasive brain monitoring device that could provide continuous data on patients with neurological conditions. The device, which the New York-based company is calling the Brain E-Tattoo, would monitor brain wave activity outside the clinical setting, allowing for long-term continuous data collection without interrupting daily life.