The 2023 American Society for Clinical Oncology Annual Meeting featured several notable developments on the diagnostics side, including significant advances in multi-cancer early detection (MCED). Grail Inc. presented its results from SYMPLIFY, the first major study of its MCED test in symptomatic patients. The test showed a negative predictive value of more than 97% and a positive predictive value that exceeded 75% in individuals who presented to primary care with non-specific symptoms that prompted a referral for cancer evaluation.

Avacta Group plc has continued its growth through M&A strategy with the acquisition of Coris Bioconcept Sprl, a developer of rapid diagnostic test kits, for an up-front cash consideration of £7.4 million (US$9.3 million). The Coris deal comes on the back of its £24 million purchase of Launch Diagnostics Holdings Ltd last year, as Avacta works on building up its diagnostics division.

α-Synucleinopathies constitute a set of neurological disorders including Parkinson’s disease (PD), dementia with Lewy bodies, multiple systems atrophy (MSA), and other rare disorders. The development of positron emission tomography (PET) tracers for imaging α-synuclein aggregates is essential for performing efficient and accurate diagnosis, tracking disease progression and monitoring efficacy of potential therapies.

Wesper Inc., a longitudinal and wireless clinical-grade sleep testing platform, showed ‘exceptional accuracy’ in a head-to-head comparison with polysomnography in a study published in The Journal of Clinical Sleep Medicine. The wireless, longitudinal sleep testing platform had a breathtaking 95% correlation with the cumbersome gold standard test for sleep apnea.

If Orlucent Inc. has its way atypical moles in adults will soon give up their secrets to clinicians on the lookout for skin cancer, this after the Los Gatos, Calif.-based company received a U.S. FDA breakthrough device designation for its non-invasive Orlucent skin fluorescence imaging system. The system is a hand-held point-of-care molecular-based imaging device that identifies “tissue remodeling activity” inside atypical moles that could be a precursor to early melanoma.

In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.

The U.S. FDA has granted 510(k) clearance to GE Healthcare Technologies Inc. for its Precision DL for PET/CT, an artificial intelligence (AI) and deep learning (DL)-powered software designed to sharpen quality and improve efficiencies in medical imaging. Part of the company’s Effortless Recon DL portfolio, the technology is available on GE’s Omni Legend PET/CT digital scanner.

Even though COVID-19 is transitioning from pandemic to endemic across the world, it will remain first in mind as U.S. lawmakers look to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year to ensure the country is better prepared for future threats. With a Sept. 30 deadline for reauthorizing PAHPA, the Senate Health, Education, Labor and Pensions (HELP) Committee has its work cut out for it. But it won’t be starting from scratch. In opening a May 4 hearing on the reauthorization, HELP Chair Bernie Sanders (I-Vt.) said the committee would build on the efforts started last year under then-Chair Patty Murray (D-Wash.) and now-retired Ranking Member Richard Burr (R-N.C.).