Adaptive Biotechnologies Corp. posted revenue of $30.2 million for the fourth quarter of 2020, up 25% from the corresponding prior year period. The tally beat consensus by $3.3 million. Clinical sequencing volume grew 41% to 4,539 clinical tests, compared with the fourth quarter of 2019. For the full year, revenue increased 16% year over year to $98.4 million, and clinical sequencing volume topped out at 15,216 clinical tests delivered, up 50%. The results coincided with the launch of the company’s T-Detect COVID, the first clinical T cell-based test to confirm recent or prior COVID-19 infection.
Keeping you up to date on recent developments in diagnostics, including: Atherosclerosis precedes clonal hematopoiesis; AI-driven tool to assess kidney function; Deep learning-powered classification of lung cancer types.
In 2020, Appliedvr Inc. reported results from a three-week proof-of-concept study showing reduction of lower back pain with the use of its Easevrx virtual reality (VR) therapy. Now the company has pivotal data affirming the benefit to patients with chronic low back pain who used Easevrx at home for eight weeks.
Grail Inc. is teaming up with Quest Diagnostics Inc. to support the upcoming launch of its multicancer blood test. The early cancer detection test, called Galleri, is slated to begin rolling out in the second quarter of 2021. Quest’s 2,200 patient service centers and network of 5,000 mobile phlebotomists will help to collect blood samples for Galleri once the test becomes available in the U.S.
The U.S. FDA has given a green light to Brainlab AG for two new additions to its robotic surgery systems. The agency granted 510(k) clearances for the Loop-X mobile imaging robot and the Cirq Robotic Alignment module for spine procedures, paving the way for U.S. market entry.
Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled specialist. Now, the Brisbane, Calif.-based company has published data showing nurses without prior ultrasound experience who used Caption Guidance software captured ultrasound images of diagnostic quality to assess known cardiac conditions.
Cardiac monitoring company Rhythmedix Inc. reported the launch of its next-generation, wearable Rhythmstar device with built-in 4G cellular connectivity. The low-profile, water-resistant cardiac telemetry monitor provides extended remote monitoring to quickly detect arrhythmia without the need for a phone or other communication device.
Humacyte Inc., which develops universally implantable, bioengineered human tissue at commercial scale, has agreed to go public via a merger with Alpha Healthcare Acquisition Corp. (AHAC), a blank-check company led by Rajiv Shukla. Upon closing of the deal, AHAC will be renamed Humacyte Inc. and will be led by Humacyte’s current CEO, Laura Niklason. The combined company’s stock is expected to list on the Nasdaq Capital Market under the ticker symbol HUMA.
Shockwave Medical Inc. said Tuesday that its intravascular lithotripsy (IVL) therapy has won U.S. FDA approval for the treatment of severe coronary artery disease (CAD). The technology, which was granted breakthrough device designation in 2019, is a novel application of lithotripsy, which has long been used to safely shatter kidney stones.