TAG:
genetic test
Tapping Molecular Pathology’s New Gold Mine
IN ONE SENSE, WE CAN SAY THAT THE DECADE OF 2001 THROUGH 2010 was bookended by two one-half billion dollar anatomic pathology acquisitions. Each transaction was a powerful signal to Wall Street investors. Unfortunately, most pathologists are not tuned into that signal and so continue to miss the mess…
Gauging the Prospects For Anatomic Pathology
CEO SUMMARY: More buyers are crowding into the lab testing industry and looking to acquire anatomic pathology testing companies. These buyers are willing to pay strong prices to acquire AP labs and companies which they determine to be a strategic fit. All of this acquisition acti…
Whole Genome Sequencing: Is It Ready for Prime Time?
CEO Summary: Pathologists at Beth Israel Deaconess Medical Center in Boston, Massachusetts, in a collaboration with GenomeQuest, Inc., will produce whole human genome sequences of patient tumors and other specimens. These whole genome sequences will be studied to learn what diagn…
Early Warning on LDTs and Pre-Authorization
ANY PATHOLOGIST OR LABORATORY MANAGER who considers this to be a quiet time in the laboratory testing industry is setting themselves up for a rude awakening in the not too distant future. Several stories in this issue are written specifically to call attention to major developments in the profession …
Lab Industry Unprepared For FDA Action on LDTs
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by …
Many Questions About FDA Regulation of LDTs
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
Systems Approach For Pre-Authorization Of Genetic Tests
CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there …
Labs Can Turn the Tables on the Payers
PRE-AUTHORIZATION OF GENETIC AND MOLECULAR TESTS is now on the radar screen of the nation’s larger health insurance companies. In most circumstances, payer pre-authorization requirements serve to exclude many smaller providers from access to patients. But local labs have a chance to guarantee their…
Payers Move to Pre-Authorize Expensive Genetic Tests
CEO Summary: Pre-authorization of expensive genetic and molecular tests is fast-becoming a priority for most of the nation’s health insurers. For clinical labs and pathology groups that don’t respond, this trend is a threat. On the other hand, because payers need all the skil…
September 13, 2010 “Intelligence: Late Breaking Lab News”
Researchers at North Carolina State University are developing a method that might make it possible to diagnose and treat cancer through the use of special microneedles they developed. NCSU researchers use the microneedles to deliver nanoscale dyes based on quantum dots to locations u…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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