AOA Dx Inc. closed an oversubscribed $17 million seed round to expand the clinical trial for its ovarian cancer diagnostic test, build out new lab facilities and explore applications of its Glycolocate platform in other cancers. The platform uses tumor marker gangliosides to enable early cancer. A recent study demonstrated that the test had more than 90% sensitivity and specificity for ovarian cancer detection across all stages.
Rhythm Diagnostic Systems SA (RDS) received €1 million (US$1.1 million) from Capital Grand Est, the first venture capital (VC) firm to join its investor pool, taking its total seed capital raised to €13 million. RDS will use the funds to progress toward the next stages in the development of its Multisense product, a remote patient monitoring solution, including market launch, once it receives CE mark from the European authorities expected by the end of the year.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.
Precede Biosciences Inc. emerged from stealth having raised $57 million in seed and series A financing to fund its genome-wide platform. The blood-based platform detects and provides critical insight into the biological activity of genes and pathways in diseased tissue to improve care and development of new therapeutics.
The U.K. has launched the first-of-its-kind national total-body positron emission tomography (PET) imaging platform that will be ‘game-changing’ for clinical research. Funded with £32 million (US$39 million) from the government, the National PET Imaging Platform (NPIP) will enable clinicians and researchers to access never-before-seen data that will improve the detection, diagnosis and treatment of complex, multi-organ diseases.
The U.S. Department of Justice (DOJ) reported on October 2 that Genomic Health Inc. (GHI), now a subsidiary of Exact Sciences Corp., has agreed to pay $32.5 million to settle allegations that the company violated the False Claims Act (FCA). The allegations include that GHI had manipulated the dates upon which a test was administered in order to boost revenues from public health programs, an activity that ended up costing the company double damages.
The receipt of a reimbursement code for the Episwitch Prostate Screening (PSE) test developed by Oxford Biodynamics plc, following its recent launch, is good news for men frustrated with the inaccuracies in prostate-specific antigen (PSA) tests and the lack of alternatives, Jon Burrows, CEO of Oxford Biodynamics told BioWorld.
The U.S. FDA has finally let fly with a draft rule for regulation of lab-developed tests (LDTs), an 83-page document that delves into the legal controversies regarding whether the agency has the requisite statutory authority. However, Allyson Mullen, a director in the D.C. office of Hyman, Phelps & McNamara P.C., told BioWorld that the emergence of this draft rule doesn’t mean Congress won’t eventually be dragged back into the LDT fray, particularly if stakeholders litigate to overturn the draft.
Following the receipt of a U.K. Conformity Assessed (UKCA) mark for its kidney function diagnostic software, the CKD Screening Prioritizer (CSP), Gendius Ltd. is hoping to soon receive CE mark and then U.S. FDA approval next year. Given that people with type 2 diabetes are at a higher risk of developing chronic kidney disease, Gendius’ pre-screening software will be “transformative” for patients and health care systems, CEO Rory Cameron told BioWorld in an interview.
Mission Bio Inc. released its Tapestri single-cell minimal residual disease (MRD) assay for acute myeloid leukemia (AML) on September 26, with the goal of enabling greater personalization of care for patients with blood cancers. The test can provide insights into the progression of AML and help identify targets for treatment in addition to identifying patients truly experiencing relapse as distinct from having pre-leukemic or precursor clones.
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