360Dx

NEW YORK — In June, the US Food and Drug Administration cleared a dozen in vitro diagnostic assays to detect infectious pathogens, acute and chronic diseases, and other health markers from manufacturers Abbot, Diasorin, Autonomous Medical Devices Incorporated (AMDI), and others. For infectious disease testing, the agency cleared two tests using molecular methods, three immunoassay technologies, a sample collection kit, and a culture-based assay.

NEW YORK – Danaher subsidiary Leica Biosystems announced this week that it has entered into a definitive agreement to acquire StatLab Medical Products, a global developer and manufacturer of anatomical pathology products, from Linden Capital Partners and Audax Private Equity. StatLab provides a broad portfolio of products to help with specimen collection and tissue processing through slide preparation and staining.

NEW YORK – The Centers for Medicare & Medicaid Services issued a request for information Thursday seeking public input on potential updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. The agency requested information on topics including breath testing, laboratory processes and procedures, emergency preparedness, biosafety and biosecurity, cybersecurity, and specialty testing areas.

NEW YORK – The US Department of Justice said Wednesday that Laboratory Corporation of America has agreed to pay $14.5 million to resolve allegations that it violated the False Claims Act. According to DOJ, Labcorp violated the law by submitting false claims to Medicare Part B for medically unnecessary urine drug testing. Specifically, the government alleges that from Jan. 1, 2018, through Nov.

Note: This story has been updated with comments from the firm's conference call. NEW YORK – Abbott said on Thursday that its second quarter Diagnostics sales grew 42 percent to $3.09 billion compared to $2.17 billion in the year-ago quarter, helped along by its acquisition of Exact Sciences in March. According to Abbott President and CEO Robert Ford, the Exact Sciences integration is expected to drive significant momentum for the company throughout the second half of this year.

NEW YORK – Shares of CareDx rocketed upwards on Thursday as the MolDx program issued a finalized local coverage determination (LCD) for molecular testing for solid organ allograft rejection that increases the number of surveillance tests that can be performed compared to a prior LCD proposal. The new LCD, which takes effect on Aug.

NEW YORK – The life science tools and diagnostics industries saw significant merger and acquisition activity in the first half of 2026, with a trio of billion-plus dollar deals leading the way. Topping the list was Merck KGaA's planned $11.3 billion acquisition of tools firm Bio-Techne, which the company announced at the end of June. Next was private equity firm Astorg's proposed $1.08 billion acquisition of Thermo Fisher Scientific's microbiology business.

NEW YORK – By the time researchers realized a strain of multi-drug resistant tuberculosis was evading standard diagnostic testing over a decade ago, it was already causing more than 30 percent of TB cases in Eswatini. With the support of international public health experts, the tiny country then known as Swaziland committed to building out its own molecular diagnostics lab.

NEW YORK – The government of England will test all babies born in the country for spinal muscular atrophy (SMA) as part of an evaluation study for expanded newborn screening, due to begin in October. The study, which is modeled on a similar, privately funded program already in effect in Scotland and is led by scientists at the University of Oxford, will inform future UK National Screening Committee recommendations on newborn SMA screening.

NEW YORK – Abbott said on Thursday that its second quarter Diagnostics sales grew 42 percent to $3.09 billion compared to $2.17 billion in the year-ago quarter, helped along by its acquisition of Exact Sciences in March. Overall, during the three months ended June 30, the Abbott Park, Illinois-based firm reported overall sales rose 13 percent year over year to $12.59 billion from $11.14 billion and beat the consensus Wall Street estimate of $12.52 billion.