The FDA has approved Cologuard Plus (Exact Sciences), a new at-home multitarget stool DNA test, for colorectal cancer (CRC) screening in average-risk adults ≥45 years old. Cologuard, the first FDA-approved multitarget stool DNA test, has been available since 2014.

The Drug Enforcement Administration (DEA) has reclassified all hydrocodone combination products as schedule II controlled substances; they were previously classified as schedule III. Hydrocodone alone (Zohydro ER) is already a schedule II controlled substance.

Three recent publications have focused attention once more on the contentious question of whether men should be screened for prostate cancer by measuring serum concentrations of prostate specific antigen (PSA).

Currently available techniques for colorectal cancer screening include fecal occult-blood testing, flexible sigmoidoscopy, double contrast barium enema (DCBE) and traditional optical colonoscopy. Optical colonoscopy requires bowel cleansing and sedation, and involves some risk, but is generally accepted as the best available method for detection of lesions and offers the advantage that polyps can be removed when they are identified. A less invasive screening tool, computed tomography (CT) colonography, also known as virtual colonoscopy (VC), offers an additional option.

Recent publicity about symptoms of ovarian cancer will prompt many questions from patients about testing for the disease. Early-stage epithelial ovarian cancer is potentially curable, with survival rates of 90-95%, but about 75% of women have advanced or metastatic disease at diagnosis. Between physical examination and exploratory surgery, 2 tests are commonly used.1Transvaginal ultrasound (TVUS) images the ovaries better than transabdominal ultrasound. In a study in which 25,327 asymptomatic women were screened with TVUS annually from 1987 to 2005, 364 patients had exploratory surgery, and 44...

Options in screening for colon cancer include fecal occult blood tests, flexible sigmoidoscopy, colonoscopy, computed tomography (CT) colonography and fecal DNA tests. Since the last Medical Letter article on this subject, more data have become available on colonography.

Serum measurements of prostate specific antigen (PSA) are now being used in the diagnosis and management of prostate cancer. Produced by prostatic epithelium, PSA is a protease involved in liquefaction of the seminal coagulum. Whether this test should be used for routine screening is a matter of controversy; it is currently approved by the US Food and Drug Administration (FDA) only for monitoring after treatment for prostate cancer.

The FDA has cleared the Lumipulse G pTau217/ β-Amyloid 1-42 Plasma Ratio (Fujirebio), a bloodbased diagnostic test, for early detection of amyloid plaque pathology associated with Alzheimer's disease (AD) in adults ≥50 years old who are showing signs and symptoms of the disease. The new assay is the first blood test for amyloid biomarkers to become commercially available in the US. The Lumipulse G β-Amyloid Ratio (1-42/1-40), which measures amyloid biomarkers in cerebrospinal fluid (CSF), was cleared by the FDA in 2022.

Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used off-label for treatment of allergic rhinitis and food allergies. Recently the results of a phase III clinical trial indicated that omalizumab may be effective in treating chronic urticaria as well.

Sapropterin (Kuvan - BioMarin) has been approved by the FDA to reduce phenylalanine plasma concentrations in patients with phenylketonuria (PKU). PKU is a rare genetic disorder (it occurs in 1 in 8000 Caucasian and 1 in 50,000 African-American newborns) caused by a deficiency of phenylalanine hydroxylase (PAH) the resulting high levels of the amino acid in blood and urine lead to cognitive, behavioral and other neurological complications.