The Wild, Wild West of Laboratory Developed Tests

Since the 1950’s, scientists have built novel technologies to screen for genetic diseases and other biological irregularities. Recently, researchers have developed a method called “liquid biopsy” (as opposed to a standard tissue biopsy) that uses a liquid sample (e.g., blood) to non‑invasively spot biomarkers indicating different types of cancers in the patient’s body. While the U.S. Food and Drug Administration (FDA) has fully cleared a small number of liquid biopsy tests under its rigorous and expensive review process, most biotech companies have instead followed a less restrictive regulatory path through the Centers for Medicare and Medicaid Services (CMS), which label the devices as “laboratory-developed tests” (LDTs). Despite Congress’ initial passage of LDT designation in the 1980’s, LDT regulation remains akin to the “Wild West,” with ongoing questions about which agency is actually in charge of LDTs. While FDA initially claimed regulatory control over LDTs, it has (until recently) left discretion to CMS. Therefore, some unscrupulous companies have tried to abuse the gray regulatory area by marketing potentially misleading scientific claims about their LDTs, comparing them to FDA‑approved tests. Competitors with fully‑approved tests are furious and have sued under federal Lanham Act claims. Because of Congress’ repeated failures to pass a law addressing these claims and modernize the regulatory path for all in-vitro diagnostic tests, the FDA has proposed its own rules amending its regulatory authority to reign in most diagnostic tests. This Note therefore suggests a multi-faceted approach to address the issue of regulating LDTs and their potentially misleading claims by (1) revising failed Congressional bills to allow regulatory and industry compromise, (2) applying certain circuit court decisions on Lanham Act claims to questionable facts in a company’s advertisements, and (3) narrowly expand the FDA’s regulatory power to all liquid biopsy tests before gradually expanding to all LDTs. Although LDTs may benefit the healthcare sector by offering novel tools to identify rare diseases, the federal government must develop an approach that both protects private parties and the general public and balances the need for research and development of life‑saving diagnostic tests

Mycenaean trade with the east Mediterranean

From archaeological evidence it is clear that the Mycenaean's enjoyed widespread commercial relations with the countries of the East Mediterranean, and this thesis is a study of the material objects of this trade. Their distinctive pottery appears to have been the most important commodity exported by the Mycenaean's: fragments and whole vases have been excavated at scores of Late Bronze Age sites in the East Mediterranean, in Asia Minor, Cyprus, Syria, Palestine and Egypt. The majority of the vases found belong to the 14th and 13th Centuries and their distribution is one of our strongest proofs for the existence of flourishing trade relations at this time. Commerce thrived because these 200 years represented a period of stability in the East Mediterranean. The great ports of the Levant and Cyprus were visited not only by Mycenaean traders but by merchants from all the neighbouring countries. Pottery was not the only commodity featured in the trade. Bronzes from Greece indicate that the Mycenaean's had an extensive metal industry and their supplies of copper and tin were imported. The copper came from Cyprus in the form of ingots. These metals were essential to a Late Bronze Age civilisation, but other finds from excavated graves and settlements on the Mainland prove that the Mycenaean's also obtained luxury materials such as gold, silver, ivory and semi-precious stones. These were imported as raw materials and then fashioned by Mycenaean craftsmen. The Linear B tablets, although they do not discuss foreign trade, throw light on some of the types of materials which must have been traded, including certain perishable goods which have not survived to be excavated by the archaeologist. Each chapter deals with a particular commodity featured in the trade, and in the conclusion the extent of trade with each country is summed up. An accompanying folder contains maps and photographs

Witchcraft and the Church in Scotland Subsequent to the Reformation

Abstract Not Provided

The Door-to-Door Mormon Pest Control Salesman: A Novel

This thesis consists of a critical introduction followed by a novel told in twenty-five chapters. The novel begins in the first person with the eighteen-year-old protagonist Kirtland Grant beginning a summer job as a door-to-door pest control salesman in Florida. Trained using Mormon missionary techniques, his office of relocated Utah boys, all of them Mormon, dodge angry homeowners and evade police in gated communities while insects root the brand-new houses from below and corrupt banking pushes the region toward collapse. With his departure date for a two-year Mormon mission looming at summer’s end, Kirt delves into Mormon doctrine and attempts to solidify his spiritual faith through a salesman’s experiment in finding God. As Kirt redoubles his efforts in faith and in sales in order to earn enough money to fund his mission, he finds himself in ethically dubious positions and comes to understand the questionable practices of the company for whom he has been selling. He simultaneously struggles to comprehend his own sexuality, and a sexual run-in with a young woman, which Kirt interprets as serious sin, triggers additional trauma and spiritual flailing. God does not commune with Kirt in any way Kirt can comprehend, and as the novel ends he is beaten, alone, but nevertheless, alive. Perhaps most critically, he has effectively quit his position in the pest control company and made a failed attempt at reconnecting with the young woman. The novel is an embodiment of the nature of belief, and examines our reliance on each other’s faith to prop up our own, whether it be faith in housing markets, pest control products, or God