Research & Development
Policy & Regulation
Trends & Finance
Castle Biosciences Pittsburgh lab receives N.Y. state permit
Castle Biosciences has received a clinical laboratory permit from the New York State Department of Health for its Pittsburgh laboratory.
September 13, 2023
Castle Biosciences Pittsburgh laboratory receives CAP accreditation
All of Castle Biosciences' laboratories are now accredited by the College of American Pathologists.
November 21, 2022
CorePath and Cizzle partner to develop lung cancer test
The companies said they will first focus on offering the proprietary test in the U.S., where lung cancer accounts for 25% of all cancer deaths.
May 25, 2022
NDRI biorepository receives CAP accreditation
The accreditation came after a recent onsite inspection as part of CAP’s accreditation programs. With this, the NDRI joins the more than 8,000 CAP-accredited biorepository facilities worldwide. The interchange was first accredited by the CAP in 2016.
March 6, 2022
FDA postpones inspections due to COVID-19
Through January 19, the agency intends to continue mission-critical international and domestic inspections, but it has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible. State inspections under FDA contracts have the discretion to make inspection decisions based on their local information, the agency said.
January 5, 2022
NFT featuring Theranos stock certificate being auctioned off
Titled "The Rise & Fall of Theranos NFT" or "The RFT - NFT," the NFT comprises a series A stock certificate for 500,000 shares of Theranos stock. The certificate was issued to entrepreneur Marc Ostrofsky, who was one of the first investors in Theranos and who worked with Jupiter Group on creating the NFT.
December 16, 2021
Quest offers Biocept's liquid biopsy test
Biocept's Target Selector NGS Lung Panel helps with the genomic profiling of patients with advanced non-small cell lung cancer. The test helps physicians identify a potential treatment target and monitor the effectiveness of patients' treatments, according to Quest.
December 1, 2021
Veracyte completes Decipher acquisition for $600M
Tina Nova, PhD, who is the previous president and chief executive officer at Decipher, has been appointed general manager of urologic cancers at Veracyte. She will continue to oversee the company's San Diego operations, including a CLIA-certified and College of American Pathologists (CAP)-accredited laboratory.
March 14, 2021
CMS to cut COVID-19 payments to slower labs
Under the new policy, labs that take longer than two days to complete COVID-19 tests will be paid $75 -- a 25% pay cut.
October 15, 2020
Pathologist workforce data miss the mark, need revision
The study was sponsored by the College of American Pathologists (CAP) and followed up on an article with workforce data published in JAMA Netw Open in May 2019. Alarmingly, that study concluded that the number of active pathologists dropped from 15,568 to 12,839 between 2007 and 2017, a trend that suggested great risk for a shortage of specialists in the field in the future. These data were based on information published by the American Association of Medical Colleges (AAMC), which in turn drew from the American Medical Association (AMA) Physician Masterfile.
July 16, 2020
Digital pathology firm Proscia receives certification for meeting global standards
The certification indicates compliance with ISO 13485 and the standards of the U.S., Australia, Brazil, Canada, and Japan. Auditing of device manufacturers for the certification includes a review of design, development, production, deployment, and sales, the company noted in a press statement.
July 13, 2020
FDA readies to resume onsite inspections
Onsite investigators will wear personal protective equipment and follow local, state, and federal guidelines, the FDA noted. The agency also said it will forewarn facilities not related to retail tobacco about upcoming inspections to ensure appropriate staff members are onsite.
July 12, 2020
Page 1 of 3