Happy Easter

 Happy Easter from my Easter Bunny, Sparrow. 

He is decorated in folklore-accurate seashells and pendants*. 

*I made that up.

Seaweed Savior

In March, Black Cat Weekly published my story The Oathbreaker. A professor is swept up in the saga of a woman doomed to spend eternity with her Viking captor. He is studying seaweed on the coast of Anglesey, Wales, when three women recruit him to save her. 

Black Cat Weekly cover

Today, the BBC published an article about a real professor who studied seaweed on the coast of Anglesey, and who is credited with saving the Japanese sushi industry. Laver is a type of seaweed that grows in green-black sheets on rocks and is used in British cooking, particularly as Welsh Laverbread.  When Kathleen Drew-Baker attempted to cultivate Laver in her laboratory, she found that seashells in the bottom of the tank developed a reddish growth. She recognized the red growth as a species of algae called Conchocelis rosea. Studying it further, she realized that C. rosea wasn't a separate species at all. Laver has two different lifestyle stages, one as a red filament growing on seashells and one as blackish sheets growing on rocks. She published her findings in the October 1949 edition of the journal Nature.

Meanwhile, in Japan, a series of storms had decimated the production of Nori, the seaweed used extensively in Japanese cuisine, especially in sushi. Sea mines and general devastation of World War Two further reduced the supply. A Japanese professor read Drew-Baker's paper and realized that the closely related Nori could be cultivated the same way. Now, the conchocelis-phase Nori is grown on oyster shells in nurseries. Nets are placed over the shells until the adult phase of Nori attaches to them, and then the nets are taken out to sea, where it grows the thin leaves that can be harvested and processed for food.  Drew-Baker's discovery was the key to the recovery of the seaweed beds.

Seaweed growing on nets from the Nori Cultivation page

Kathleen Drew-Baker's story has another angle. Although she was an academic all her life, she was unpaid for most of it. Back then, the university would not employ married women. When she married she was offered the opportunity to continue working, but she was not on the payroll.

If my three angry women had met Kathleen when she came to Anglesey, they would have had a lot to discuss about the very slow pace of improvement in women's rights.

Federal Judge rules that FDA's attempt to regulate clinical laboratories exceeds its authority

Overview
On March 31, 2025, a federal court vacated the FDA's final rule attempting to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The ruling is a significant victory for clinical laboratories across the country.

FDA regulates test kits (like home Covid test kits) as "medical devices" and has developed stringent requirements for their manufacture and sale. An LDT is a service, agreed between the patient's medical doctor and the medical doctor in the laboratory, to test the patient's specimen for various "analytes" (antibodies to viruses, hormones, viral particles, etc.). These tests are developed by the laboratory because manufactured kits are not available for the exact test the patient needs. The FDA had asserted a right to regulate LDTs as medical devices.  

The advantage of LDTs is that they can be tailored to fit these needs quickly and for far less cost than asking a kit manufacturer to create a specialized test and obtain FDA approval. LDTs are regulated by the Center For Medicare and Medicaid Services (CMS) and the Clinical Laboratory Improvements Amendments (CLIA) which require the lab to "establish performance characteristics" --prove that the test works as claimed-- and retain the proof for inspection by CMS. 

FDA's decision to regulate LDTs would have resulted in double regulation (CMS and FDA), slowed innovation and cost billions of dollars, which would ultimately be passed on the patient.

The rule would subject about 79,114 existing LDTs and 1,181 labs to FDA premarket reviews, post-market surveillance, and quality system requirements. "FDA acknowledged that the costs of the proposed rule would be significant. Specifically, it estimated that the cost of preparing and submitting [applications] for existing laboratory-developed tests would exceed $35 billion and could reach $113 billion. It also projected that, going forward, annual compliance costs for affected laboratories would range from $4 billion to $14 billion." (From the judgment linked below.)

On March 31, 2025, a federal court vacated the FDA's rule to regulate LDTs as medical devices, marking a significant legal setback for the agency. Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the FDA lacks statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA) and CLIA to oversee LDTs, which he characterized as diagnostic services rather than physical medical devices.

The court emphasized that Congress designed CLIA as the primary regulatory framework for clinical laboratories, delegating oversight to CMS rather than the FDA. LDTs were deemed "proprietary methodologies" rather than physical devices, placing them outside the FDA’s jurisdiction.

Of course, FDA may appeal the decision, or Congress may act and change the requirements by law. 

I know laboratories have already spent large amounts attempting to get ready for the May 2025 deadline. (I should have taken up the offer to act as a consultant...too late now.) My advice is to keep doing all the things the FDA has so far required. No harm, and possibly great good, will come from having properly documented complaints procedures and test development and change files beyond the original CLIA requirements. 

The judge's ruling in full.