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LACK OF STANDARDIZATION ACROSS MDX INFECTIOUS DISEASE TESTS COULD UNDERMINE
PANDEMIC PREPAREDNESS
PREMIUM

Poor cross-compatibility may make it difficult to substitute components of
automated sample processing and testing workflows in the case of shortages.


QUEST DIAGNOSTICS CONSUMER-INITIATED ALZHEIMER'S BLOOD TEST RAISING CONCERNS
AMONG EXPERTS
PREMIUM

Researchers and clinicians have highlighted the lack of data supporting the test
and warned that false positive results could further tax overburdened memory
clinics.


NY STATE DATABASE OFFERS GLIMPSE INTO LABORATORY-DEVELOPED TESTING LANDSCAPE
PREMIUM

Large national labs and applications like oncology, genetics, and infectious
disease dominate the database, which comprises more than 10,000 LDTs.


RESEARCHERS USE DNA NANOBALLS, BIOSENSORS TO CREATE LOW-COST DIAGNOSTICS
PREMIUM

The creation of DNA nanoballs allows for the use of more simplified detection
techniques, which potentially reduces the cost of testing.


SCIPHER MEDICINE TO EXPAND ARTHRITIS THERAPY RESPONSE TEST, AIMING TO MAXIMIZE
MEDICARE COVERAGE
PREMIUM

The company is collecting the data necessary to add at least two other drugs to
its current TNFi response predictor, which it believes will accelerate adoption.


DELVE BIO SEEKS TO COMMERCIALIZE UCSF METAGENOMIC PATHOGEN TEST
PREMIUM

In addition to proving clinical utility, the startup will have to navigate
issues of regulatory strategy, sequencing technology, and additional
indications.
Business, Policy & Funding


 * MEDTECH EUROPE CALLS FOR REFORMS TO IVDR, MDR REGULATIONS


 * IN BRIEF THIS WEEK: QUEST DIAGNOSTICS, DANAHER, TRINITY BIOTECH, ONCGNOSTICS,
   PRENETICS


 * SCIPHER MEDICINE TO EXPAND ARTHRITIS THERAPY RESPONSE TEST, AIMING TO
   MAXIMIZE MEDICARE COVERAGE
   PREMIUM


 * DELVE BIO SEEKS TO COMMERCIALIZE UCSF METAGENOMIC PATHOGEN TEST
   PREMIUM


 * QLUCORE MOVES CLOSER TO IVDR CERTIFICATION OF DX SOFTWARE FOR LEUKEMIA
   TESTING
   PREMIUM

Diagnostics


 * MEDTECH EUROPE CALLS FOR REFORMS TO IVDR, MDR REGULATIONS


 * SCIPHER MEDICINE TO EXPAND ARTHRITIS THERAPY RESPONSE TEST, AIMING TO
   MAXIMIZE MEDICARE COVERAGE
   PREMIUM


 * I-SPY 2 TRIAL TO EVALUATE NATERA'S SIGNATERA FOR POST-NEOADJUVANT BREAST
   CANCER MONITORING


 * RESEARCHERS USE DNA NANOBALLS, BIOSENSORS TO CREATE LOW-COST DIAGNOSTICS
   PREMIUM


 * MAINZ BIOMED STOCK SPIKES ON POSITIVE DATA FOR MRNA-ENHANCED COLORECTAL
   CANCER SCREENING ASSAY

Disease Areas


 * SCIPHER MEDICINE TO EXPAND ARTHRITIS THERAPY RESPONSE TEST, AIMING TO
   MAXIMIZE MEDICARE COVERAGE
   PREMIUM


 * I-SPY 2 TRIAL TO EVALUATE NATERA'S SIGNATERA FOR POST-NEOADJUVANT BREAST
   CANCER MONITORING


 * MAINZ BIOMED STOCK SPIKES ON POSITIVE DATA FOR MRNA-ENHANCED COLORECTAL
   CANCER SCREENING ASSAY


 * QLUCORE MOVES CLOSER TO IVDR CERTIFICATION OF DX SOFTWARE FOR LEUKEMIA
   TESTING
   PREMIUM


 * A3P BIOMEDICAL, BIOAGILYTIX PARTNER TO BRING PROSTATE CANCER TEST TO US

Clinical Lab Management


 * LOUISIANA LAB OWNER SENTENCED TO THREE YEARS IN FEDERAL PRISON FOR $45M LAB
   FRAUD SCHEME


 * LACK OF STANDARDIZATION ACROSS MDX INFECTIOUS DISEASE TESTS COULD UNDERMINE
   PANDEMIC PREPAREDNESS
   PREMIUM


 * QUEST DIAGNOSTICS CONSUMER-INITIATED ALZHEIMER'S BLOOD TEST RAISING CONCERNS
   AMONG EXPERTS
   PREMIUM


 * NY STATE DATABASE OFFERS GLIMPSE INTO LABORATORY-DEVELOPED TESTING LANDSCAPE
   PREMIUM


 * CHICAGO DOCTOR CONVICTED IN $9.5M GENETIC TESTING FRAUD CASE

Breaking News


 * LOUISIANA LAB OWNER SENTENCED TO THREE YEARS IN FEDERAL PRISON FOR $45M LAB
   FRAUD SCHEME


 * MEDTECH EUROPE CALLS FOR REFORMS TO IVDR, MDR REGULATIONS


 * IN BRIEF THIS WEEK: QUEST DIAGNOSTICS, DANAHER, TRINITY BIOTECH, ONCGNOSTICS,
   PRENETICS


 * I-SPY 2 TRIAL TO EVALUATE NATERA'S SIGNATERA FOR POST-NEOADJUVANT BREAST
   CANCER MONITORING


 * MAINZ BIOMED STOCK SPIKES ON POSITIVE DATA FOR MRNA-ENHANCED COLORECTAL
   CANCER SCREENING ASSAY


 * A3P BIOMEDICAL, BIOAGILYTIX PARTNER TO BRING PROSTATE CANCER TEST TO US



What's Popular?


 1. MEDTECH EUROPE CALLS FOR REFORMS TO IVDR, MDR REGULATIONS


 2. IN BRIEF THIS WEEK: QUEST DIAGNOSTICS, DANAHER, TRINITY BIOTECH,
    ONCGNOSTICS, PRENETICS


 3. RESEARCHERS USE DNA NANOBALLS, BIOSENSORS TO CREATE LOW-COST DIAGNOSTICS
    PREMIUM


 4. LACK OF STANDARDIZATION ACROSS MDX INFECTIOUS DISEASE TESTS COULD UNDERMINE
    PANDEMIC PREPAREDNESS
    PREMIUM


 5. QUEST DIAGNOSTICS CONSUMER-INITIATED ALZHEIMER'S BLOOD TEST RAISING CONCERNS
    AMONG EXPERTS
    PREMIUM




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