CLN - Industry Playbook
Cardio Diagnostics Holdings has announced that its PrecisionCHD and Epi+Gen coronary heart disease (CHD) tests have preliminary pricing determinations from the Centers for Medicare and Medicaid Services (CMS).
PrecisionCHD, a blood test powered by artificial intelligence (AI), aids diagnosis of coronary heart disease (CHD) by evaluating genetic and epigenetic markers. Epi+Gen CHD assesses the three-year risk for a CHD event, including heart attack, using a similar AI-driven integrated genetic-epigenetic approach.
The company developed and validated the test using machine learning techniques that rely on datasets from the Framingham Heart Study and Intermountain Healthcare. It incorporates several single nucleotide polymorphisms and methylation markers.
CMS recently issued preliminarily determinations to price both PrecisionCHD and Epi+Gen CHD on a gapfill basis because the tests have no fee scheduling pricing history. The determinations serve as crucial steps toward securing Medicare reimbursement. If finalized, the determinations will be effective for claims with dates of service on or after Jan. 1, 2025, and will allow Medicare contractors to determine pricing for PrecisionCHD and Epi+Gen CHD based on actual cost data from Cardio Diagnostics, the company said.
Amipron has announced an initial $6 million close of $15 million in Series B financing to drive development of what it calls disruptive new assays for Parkinson’s disease, Alzheimer’s disease, Lewy body dementia, and other neurological disorders.
The financing from Formation Venture Engineering (FVE) with participation by Eli Lilly and Company and Amprion’s Series A investors will expand Amprion’s commercial reach and increase research and development investment.
Through Amprion, seed amplification testing — which enables detection of small amounts of misfolded proteins in cerebrospinal fluid and other biological samples – has evolved. Amprion's SAAmplify-ɑSYN biomarker test is the only validated seed amplification assay available to aid diagnosis of synucleinopathies associated with Parkinson’s disease, Lewy body dementia, and Alzheimer’s disease with neocortical Lewy body copathology.
FVE officials said they believe “the shift to diagnosis based on biology, rather than symptomology, will be transformative for patients and clinicians.”
Veravas, Inc. and Phanes Biotech recently announced a collaboration to develop a blood-based Alzheimer’s disease (AD) tau pathology test.
The test will leverage Veravas’ proprietary VeraBIND technology and Phanes’ biological intellectual property on tau pathology to detect active disease through measurable binding activity between hyperphosphorylated tau (HPT) and normal tau (nTau), a hallmark of AD.
The partnership will focus on measuring disease pathology. The goal is to combine Veravas’ VeraBIND platform with Phanes’ proprietary tau pathology insights to give clinicians a positive or negative answer about whether a patient has AD early in disease progression, when treatment is most likely to be effective.
A recent multiyear exclusive U.S. agreement gives Cardinal Health exclusive rights to sell T2 Biosystems’ FDA-cleared direct-from-blood diagnostics for the rapid detection of sepsis-causing pathogens.
The deal includes the T2Dx Instrument, the T2Bacteria Panel, and the T2Candida Panel. The T2Bacteria Panel detects E. faecium, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa, and E. coli., which account for nearly 75% of U.S. bacterial bloodstream infections, with 90% sensitivity and 98% specificity.
The T2Candida Panel detects the Candida species C. albicans, C. tropicalis, C. parapsilosis, C. krusei, and C. glabrata, which account for up to 95% of U.S. Candida blood stream infections, with 91% sensitivity and 99% specificity. The panels are not affected by prior antimicrobial treatment.
T2 Biosystems says its diagnostics can detect sepsis-causing bacterial and fungal pathogens directly from blood in just 3-5 hours, without the need to wait days for a positive blood culture. Blood culture, the most common means of identifying sepsis, is beset by low sensitivity, slow time to result, vulnerability to contamination, reduced effectiveness in patients who have received antibiotics, and a labor-intensive process requiring skilled technicians, the company said.
Sapio Sciences has entered a comarketing agreement with the Waters Corporation to improve data integrity, workflow efficiency, and laboratory productivity, Sapio announced recently.
The data processing and review capabilities of Waters Connect software, when combined with Sapio LIMS, can help laboratories make their workflows more efficient, enabling laboratories to handle larger volumes of samples with greater speed and precision. This connectivity not only streamlines operations but also enhances collaboration among laboratory personnel by providing a unified solution for data sharing and analysis, Sapio said.
Integrating liquid chromatography mass spectrometry software with a laboratory information management system (LIMS) can make laboratory operations more efficient as laboratory-based organizations expand and handle more samples. Improvements can include streamlining workflows, reducing data silos, enhancing compliance with regulatory standards, and eliminating manual data entry and transcription errors.
Eurofins has reached an agreement with SYNLAB to acquire its clinical diagnostics operations in Spain, Eurofins recently announced.
The transaction, expected to close in 2025, will cover laboratory services provided to public and private clients in all regions of the country. The combined company will have a highly specialized workforce of more than 2,000 employees and a large portfolio of clinical diagnostic laboratory tests.
SYNLAB’s clinical diagnostics operations in Spain include genetics and anatomical pathology services. Eurofins Megalab will provide all types of clinical diagnostics testing and manage intrahospital laboratories in Spain.
Eurofins officials said the company aims to provide high quality and accessible testing services to both the private and public sector, including regional healthcare services, private hospital groups and insurance companies.