Diagnostics

Roche develops PCR test to detect the Ebola Bundibugyo virus

Fri, 05 Jun 2026 12:00:00 -0400

Roche Holding AG has rapidly developed a research-use only molecular PCR test to detect the rare Ebola Bundibugyo virus, to support response efforts amid the ongoing outbreak in the Democratic Republic of Congo and Uganda. The test comes as commentary in The Lancet this week underscored the urgent need for a fit-for-purpose diagnostic test, as it warned that the absence of reliable testing is hampering efforts to ascertain the scale of the epidemic and understand the transmissibility of this strain of Bundibugyo virus.

Preclinical evaluation of a CAIX-targeted PET tracer

Fri, 05 Jun 2026 09:00:00 -0400

The University of Texas MD Anderson Cancer Center reported findings from studies of CBT-001-2334, a radionuclide peptide targeting carbonic anhydrase IX (CAIX/CA9) designed for diagnostic gallium labeling and downstream therapeutic isotope pairing. It features a DOTA chelator for use in theranostic applications through chelating either diagnostic or therapeutic radionuclides. Because it has limited expression in normal tissue, CAIX is an attractive target in clear cell renal cell carcinoma (ccRCC).

Mammogen raises $30M for blood-based breast cancer detection assay

Wed, 03 Jun 2026 12:00:00 -0400

Mammogen Inc. raised $30 million in equity financing in a series A round to support the clinical advancement and commercialization of its RNA-powered molecular diagnostics platform. The company’s lead product is Gentru-breast, a blood-based assay designed to detect molecular signatures associated with breast cancer from a simple blood draw.

ASCO 2026: Grail shifts focus to secondary endpoints in UK study

Mon, 01 Jun 2026 12:00:00 -0400

New data from Grail Inc.’s randomized study of its Galleri multicancer early detection test could not alter the fact that the U.K. trial missed the primary endpoint of reducing the number of cancers diagnosed at stage III and stage IV. But the company is now suggesting that discounting the initial screen, when most late stage cancers were detected, would be more representative of a real-life steady state screening program.

Sizing up an epidemic, with diagnostics and bioinformatics

Thu, 21 May 2026 10:00:00 -0400

It is not surprising that a large Ebola outbreak would be considered a public health emergency of international concern. But the current PHEIC is notable for the speed with which it was declared, speaking to the urgency of the situation. World Health Organization Director-General Tedros Adhanom Ghebreyesus declared the outbreak a PHEIC on Sunday, May 17, without first convening an emergency committee. That step is unprecedented.

Sizing up an epidemic, with diagnostics and bioinformatics

Wed, 20 May 2026 12:00:00 -0400

FDA approval advances personalized cancer diagnostics

Wed, 20 May 2026 12:00:00 -0400

The evolution of cancer diagnostics continues with the FDA’s May 20 approval of Guardant Health Inc.’s Guardant360 Liquid cDx. The new blood-based comprehensive genomic test assesses a 100-times wider genomic footprint than the previously approved Guardant360 cDx to deliver comprehensive tumor profiling results, according to the company. It noted that the seven companion diagnostic indications already approved for the older test will transfer to the new one.

Roche secures CE mark for Alzheimer’s blood test

Tue, 12 May 2026 12:00:00 -0400

Roche Holding AG secured CE marking for the Elecsys plasma phosphorylated-tau 217 blood test designed to rule in and rule out amyloid pathology, a hallmark of Alzheimer's disease. Developed with Eli Lilly and Co., the test brings to the market another much-needed solution to help clinicians diagnose Alzheimer’s patients following the FDA approval of Fujirebio Diagnostics Inc.’s blood test last year.

Roche to acquire Pathai for up to $1.05B

Thu, 07 May 2026 12:00:00 -0400

Roche Holding AG has agreed to acquire Pathai Inc. for up to $1.05 billion in a bid to strengthen its position in digital pathology and enhance its biopharma services. The move builds on a partnership established between the two companies in 2021, and expanded in 2024, to include the development of AI-enabled companion diagnostic algorithms.

Caredx to acquire Naveris for up to $260 million

Wed, 29 Apr 2026 12:00:00 -0400

Caredx Inc. has agreed to acquire Naveris Inc., a precision oncology diagnostics company, for up to $260 million, as part of its strategy to accelerate growth. The acquisition comes as Caredx, an organ transplant diagnostic firm, reshapes its portfolio, expanding its oncology profile while recently divesting its lab products business.

Detecting the invisible: minimal residual disease at AACR 2026

Fri, 24 Apr 2026 09:00:00 -0400

Minimal residual disease (MRD) has become a central concept in modern oncology, reshaping how clinicians evaluate response, relapse risk and treatment precision. As increasingly sensitive technologies reveal traces of cancer that persist after therapy, MRD is emerging as both a biological challenge and a clinical opportunity, especially as new data illuminate its complexity across hematologic and solid tumors. This topic was addressed at the 2026 American Association for Cancer Research (AACR) annual meeting.

Kaleidoscope-like ‘engineered disorder’ expands imaging potential

Tue, 21 Apr 2026 09:00:00 -0400

A new metasurface design strategy that replaces rigid order with “engineered disorder” could significantly increase how many optical functions can be integrated into a single ultra-thin device without increasing size or complexity, according to a study published in Nature Communications. The study challenges a longstanding assumption in optical engineering that highly ordered, periodic structures are required to precisely control light.

Foundation Medicine buying Saga Dx and its MRD test for $595M

Thu, 16 Apr 2026 12:00:00 -0400

Nearly a year after the first U.S. commercial launch of the multicancer molecular residual disease (MRD) detection platform Pathlight, developer Saga Diagnostics entered a definitive merger agreement under which Roche Holding AG subsidiary Foundation Medicine Inc. will take over the firm in return for up to $595 million in payments.

Kaleidoscope-like ‘engineered disorder’ expands imaging potential

Thu, 16 Apr 2026 09:00:00 -0400

Mabwell announces Chinese clinical trial clearance for SST-001

Wed, 15 Apr 2026 09:00:00 -0400

Mabwell (Shanghai) Bioscience Co. Ltd. has announced that SST-001 (18F-FD4), an α-synuclein-targeted PET tracer developed by Mabwell’s incubated company Synusight Biotech, has received clinical trial clearance from China’s National Medical Products Administration (NMPA). The planned phase I trial will enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease.

Regeneron enters radiopharma space via Telix deal

Tue, 14 Apr 2026 12:00:00 -0400

Regeneron Pharmaceuticals Inc. is entering the radiopharmaceutical space via a collaboration with Telix Pharmaceuticals Ltd. to jointly develop and commercialize next-generation radiopharmaceutical therapies.

Regeneron enters radiopharma space via Telix deal

Mon, 13 Apr 2026 12:00:00 -0400

Revenio speeds up growth acquiring Visionix for €290M

Mon, 13 Apr 2026 12:00:00 -0400

Revenio Group Oyj has agreed to acquire ophthalmic diagnostics company Visionix International SAS for an enterprise value of €290 million (US$339 million) as it looks to become a leading player in the global eye care market. The deal expands Revenio’s offering with a highly complementary product and software portfolio, including optical coherence tomography equipment, an important and growing segment which is new to the company.

Whoop secures $575M, with Abbott a strategic investor

Tue, 31 Mar 2026 12:00:00 -0400

Whoop Inc. secured $575 million in a series G funding round at a $10.1 billion valuation to advance its AI-powered wearable platform for personalized and preventive health care. Abbott Laboratories joined the round as a strategic investor, backing the company’s push to expand access to its device amid growing demand.

Supreme Court shuts the door to three life sciences petitions

Tue, 31 Mar 2026 11:00:00 -0400

What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list.

University of Texas prepares RIPK1 PET imaging agents

Mon, 30 Mar 2026 09:00:00 -0400

A University of Texas System patent describes new radiolabeled positron emission tomography (PET) imaging agents targeting receptor-interacting serine/threonine-protein kinase 1 (RIPK1; RIP-1). As such, they are potentially useful for the diagnosis of cancer, retinal and autoimmune diseases, neurological and inflammatory disorders.

FDA reclassifies skin lesion diagnostic devices

Wed, 25 Mar 2026 12:00:00 -0400

The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.

How to grow a startup in the AI era: MedTech Spotlight Korea 2026

Tue, 24 Mar 2026 12:00:00 -0400

AI and advanced biotechnology are reshaping South Korea’s med-tech sector, but great technology alone is not enough to build a successful medical device company, speakers said at MedTech Innovator’s Medtech Spotlight: New Impact Korea 2026.

How to grow a startup in the AI era: MedTech Spotlight Korea 2026

Mon, 23 Mar 2026 12:00:00 -0400

Roche secures CE mark for blood test to identify ApoE4 carriers

Tue, 17 Mar 2026 12:00:00 -0400

Roche Holding AG received CE Mark approval for its Elecsys Apolipoprotein E4 (ApoE4) biomarker test, an in vitro diagnostic immunoassay to identify the ApoE4 gene variant from a blood sample. With APOE4 considered as the strongest genetic risk factor for developing Alzheimer’s disease, the test provides a fast, reliable way to determine whether an individual carries the genetic variant without the need for DNA‑based genotyping.

Precision psychiatry beyond, or before, biomarkers

Fri, 13 Mar 2026 09:00:00 -0400

There is broad agreement that psychiatric diagnoses in their current form are not reflective of any underlying biology, and that this is one of the things hampering psychiatric drug development. “We are still fully reliant on descriptive diagnoses that yield heterogeneous patient cohorts,” Steve Hyman told the audience at the European Congress of Neuropsychopharmacology (ECNP) Roadmap Meeting on Precision Psychiatry in Amsterdam in January.

Agilent buys Biocare for $950M

Mon, 09 Mar 2026 12:05:00 -0400

Agilent Technologies Inc. has agreed to buy Biocare Medical LLC for $950 million in cash in a bid to strengthen its pathology portfolio. The deal adds Biocare’s complementary immunohistochemistry antibodies, reagents and instruments portfolio to Agilent’s existing offerings, and expands its ability to serve a wider range of pathology laboratories across clinical and research settings.

MSD synthesizes α-synuclein PET agents

Fri, 06 Mar 2026 08:00:00 -0500

Merck Sharp & Dohme LLC (MSD) has prepared and tested new positron emission tomography (PET) agents for binding and imaging α-synuclein (SNCA) for the diagnosis of Parkinson’s disease.

US Fed Circuit protects 101 passage for some gene therapy patents

Tue, 24 Feb 2026 12:00:00 -0500

In handing a win to Regenxbio Inc., the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patent eligibility threshold after years of Supreme Court decisions cluttering the passageway.

Grail shares plunge after Galleri test misses primary endpoint

Fri, 20 Feb 2026 12:00:00 -0500

Grail Inc.’s share price dropped more than 50% in premarket trading Feb. 20 after it reported late the day before that the NHS-Galleri trial did not meet its primary endpoint. The U.K study, done though the National Health Service with 142,000 individuals enrolled, evaluated the ability of Grail’s Galleri multicancer early detection test to look for cancer-specific methylation patterns in blood.