Authorization Sought For Clever Test That Tells If You Need A Covid Shot

Houston Chronicle: Houston Startup Requests Emergency Authorization For COVID Antibody Test
A Houston startup has developed a revolutionary COVID-19 test that can measure immunity levels and determine whether or when people need a new vaccine or booster to protect themselves from the disease. The instant test could be on the market soon, if the Food and Drug Administration grants the new device fast-track approval. Knowing personal immunity levels could become increasingly important in the face of new variants, like omicron. (Tomlinson, 12/1)

On covid research —

CIDRAP: COVID-19 Infection Linked To Myocarditis In College Athletes
A small but significant percentage of college athletes with COVID-19 develop myocarditis, a potentially dangerous inflammation of the heart muscle, according to a study presented yesterday at the annual meeting of the Radiological Society of North America (RSNA). Myocarditis typically follows bacterial or viral infections. In college athletes, previous damage and scarring to the heart muscle caused by myocarditis has been linked to up to 20% of sudden athlete deaths. (11/30)

CIDRAP: Study Ties Long-Haul COVID-19 With Chronic Fatigue, Breathing Problems
Many COVID-19 survivors experience impaired circulation, abnormal breathing patterns, and chronic fatigue syndrome an average of 9 months after diagnosis, finds a small, single-center study yesterday in JACC: Heart Failure. In the first study to link long-haul COVID-19 with chronic fatigue syndrome, researchers from the Icahn School of Medicine at Mount Sinai used cardiopulmonary exercise testing (CPET) and symptom reports to find the causes of shortness of breath in 23 women and 18 men with long-haul COVID. (11/30)

CIDRAP: Weak Immune Systems Tied To More COVID-19 Breakthrough Infections
While COVID-19 breakthrough infections—cases after vaccination—are rare, fully vaccinated people with compromised immune systems have them three times more often than those with strong immune systems and have more severe illnesses, according to a real-world US study involving nearly 1.3 million people. In the retrospective study, published today in the Journal of Medical Economics, a team led by researchers from Pfizer analyzed the health records of 1,277,747 people aged 16 or older who had received two doses of the Pfizer/BioNTech COVID-19 vaccine from Dec 10, 2020, to Jul 8, 2021. The latter part of the study period included the emergence of the Delta (B1617.2) variant in the United States. (Van Beusekom, 11/30)

Also —

Stat: Immunogen Hits Primary Goal Of Shrinking Tumors In Ovarian Cancer Patients
An antibody treatment that delivers a targeted dose of chemotherapy directly to cancer cells shrank tumors in advanced ovarian cancer patients, achieving the primary goal in a late-stage clinical trial, the treatment’s maker, Immunogen, said Tuesday. Based on the study outcome, Immunogen plans to submit the treatment — a so-called antibody drug conjugate — for accelerated approval with the Food and Drug Administration in early 2022. If cleared, it would be the 40-year-old company’s first wholly owned cancer medicine to reach the market. (Feuerstein, 11/30)

Fox News: FDA Approves 'Glowing Tumor' Drug To Help Surgeons Identify Ovarian Cancer Cells
Cytalux (pafolacianince), a drug that binds to ovarian cancer tissue and glows when exposed to fluorescent light, has been approved by the U.S. Food and Drug Administration (FDA) to help surgeons detect ovarian tumors during surgical procedures in patients. A Purdue University spokesperson told Fox News that Philip Low, Purdue University's Presidential Scholar for Drug Discovery, invented the drug. Low described in a press release that when a surgeon turns on the near-infrared light during the surgery, "those lesions light up like stars against a night sky." (McGorry, 11/30)