Brian Casey[email protected]Federal LegislationCoronavirus symptoms take 5 days | VALID Act gets revived | FDA defends coronavirus responseDear LabPulse Member,March 9, 2020CollaborationFDA defends approach to coronavirus diagnostic testingThe U.S. government's approach to diagnostic testing for SARS-CoV-2 has come under fire from critics who believe that unnecessary and overlapping regulation has slowed the distribution of tests to labs in the field. In an effort to address the situation, an updated version of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was introduced in Congress last week.March 8, 2020Healthcare ReformRevival of VALID Act draws mixed responseThe issue of diagnostics regulation has emerged as a political lightning rod, with some faulting the Trump administration's response to the outbreak and others blaming what they claim is a history of federal overregulation of clinical labs.March 8, 2020Health TopicsCoronavirus turns diagnostic testing into political footballIn the news conference, Trump claimed that the Obama administration "made a decision on testing that turned out to be very detrimental to what we're doing." Trump claimed that his administration overturned the decision to enable testing to take place in a "more accurate and rapid fashion."March 4, 2020Emergency Use AuthorizationFDA lets labs move ahead on in-house coronavirus testsThe FDA had already granted emergency use authorization (EUA) to labs to use a diagnostic assay developed by the U.S. Centers for Disease Control and Prevention (CDC) to detect SARS-CoV-2, which causes the respiratory illness COVID-19. But many health authorities have complained that the CDC test is not being supplied in enough volume to meet rapidly growing needs across the country to test individuals who may have been exposed to the virus.February 28, 2020Moderate Complexity TestCMS offers guidance on use of CDC coronavirus testThe coronavirus has been spreading quickly since the first cases began appearing in Wuhan, China, in December 2019. Diagnostic tests that can identify the virus are a key tool in determining whether individuals have been infected, but so far in the U.S. the CDC's diagnostic test is the only one routinely available. The real-time reverse transcription polymerase chain reaction (RT-PCR) diagnostic panel was developed using sequencing information made public by Chinese authorities.February 5, 2020Health TopicsCDC says traveler brought China coronavirus to U.S.The individual returned from Wuhan to the U.S. on January 15, and shortly thereafter was confirmed to have been infected with 2019 novel coronavirus (2019-nCoV). The outbreak has worried public health authorities across the globe, as coronaviruses can be highly contagious and are often fatal, such as with severe acute respiratory syndrome (SARS).January 20, 2020LeukemiaU.S. cancer death rate drops againIn fact, the decline in cancer mortality from 2016 to 2017 was the largest single-year drop ever recorded, the ACS noted. Overall, the death rate from cancer declined at an annual rate of 1.5% from 2008 to 2017 -- indicating that 2.9 million cancer deaths have been avoided since 1991, according the report, "Cancer Statistics, 2020," published in CA: A Cancer Journal for Clinicians.January 7, 2020510(k)CDC finds vitamin E acetate in 100% of vaping casesThe discovery reinforces suspicion that vitamin E acetate is the cause of a series of cases of what the CDC has dubbed EVALI (e-cigarette, or vaping, product use-associated lung injury). It is believed that the substance is added to cannabinoid products sold online that have not been approved by the U.S. Food and Drug Administration.November 7, 2019SepsisAACC: Inflammatix sepsis test wins Disruptive Technology contestIn the second annual edition of the competition, the company's HostDx Sepsis test for detecting sepsis won the majority of votes from an expert panel of five judges, as well as the audience participation vote. Inflammatix CEO Dr. Tim Sweeney, PhD, accepted a $5,000 prize on behalf of the Burlingame company for winning the award.August 5, 2019Previous PagePage 4 of 6Next PageTop StoriesFDA ClearancePillar Biosciences gets FDA approval for NGS solid tumor profiling testPillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.ValidationImmunovia announces positive results for next-gen pancreatic cancer testCollaborationVertex to pay $25M upfront to scale cell manufacturing technologyMergers & AcquisitionsLabcorp buys Invitae portfolio for $239MSponsor ContentVisit our Molecular Diagnostics Community