Castle Biosciences Inc. deepened the moat around its position in melanoma diagnostics with the acquisition of Myriad Mypath LLC from Myriad Genetics Inc. The acquisition gives Castle (NASDAQ:CSTL) the Myriad Mypath Laboratory in Salt Lake City where the Mypath Melanoma 23-gene expression profile (GEP) test is owned and offered. Mypath Melanoma joins Castle's Decisiondx Diffdx-Melanoma, enabling Castle to provide comprehensive molecular testing for difficult-to-diagnose melanocytic lesions.

TORONTO – Breath analytics technology developed by Picomole Inc. and University of New Brunswick (UNB) researchers promises to identify lung cancer long before it reaches the most advanced stages of the disease. Machine learning sits at the heart of the system, evaluating raw spectral data from a patient’s breath for early diagnosis of lung cancer, Steve Graham, CEO of Moncton, New Brunswick-based Picomole, told BioWorld.

A study led by Chinese radiologists at Peking University in Beijing has shown that positron emission tomography imaging of intercellular adhesion molecule-1 (ICAM-1) expression is a predictor for the abscopal effect, whereby nonirradiated cancers respond to radiotherapy.

The FDA has approved Roche AG’s Ventana MMR Rxdx panel for patients with advanced or recurrent endometrial cancer. The companion diagnostic is the first to identify patients who are eligible for treatment with Glaxosmithkline plc’s (GSK’s) Jemperli (dostarlimab-gxly) monotherapy. The PD-1 antibody immunotherapy received FDA approval on Thursday.

TORONTO – Perimeter Medical Imaging Inc. has been awarded an FDA breakthrough device designation for a machine learning medical platform it said drives ultra-high-resolution, real-time imaging of breast cancer. Data collected from multiple pathology labs in Texas this past year were fed through the optical coherence tomography (OCT) imaging system which now is at the stage where its Imgassist artificial intelligence (AI)-based algorithms can be tested.

LONDON – Startup company Glucomodicum Oy is preparing to commercialize a new technique for the needle-free monitoring of blood glucose levels, applying the principles of magnetohydrodynamics to noninvasively extract interstitial fluid through the skin.

HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.

The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.

Tesseract Health Inc. has closed an oversubscribed series B financing, reeling in $80 million with support from Foresite Capital, Glenview Capital and Opaleye. The proceeds will be used to advance the company’s Tesseract Ic eye-imaging diagnostic technology platform, including U.S. and overseas regulatory clearances. This is the first independent financing round for the Guilford, Conn.-based startup, which is developing a platform capable of diagnosing a range of diseases without a single blood draw. The company received prior seed funding as part of the 4Catalyzer med-tech incubator.