The Food and Drug Administration (FDA) has permitted marketing of the Miris Human Milk Analyzer, a new test that uses an infrared spectroscopy system to measure nutrients in breast milk, including the concentration of fat, carbohydrate, and protein. The test also calculates the total solids and energy contained in breast milk. It is designed to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions. Determining the macronutrient content of a mother’s breast milk could enable healthcare teams and parents to make more informed decisions about how to fortify breast milk based on an infant’s individual needs.

FDA assessed the test’s performance through the agency’s de novo premarket review pathway. To evaluate the test, FDA looked at data from a study in which Miris tested 112 samples of human milk with its analyzer, then compared these results with the expected true values obtained by an independent method. Both methods provided similar results, showing that the Miris Human Milk Analyzer effectively determines nutrient levels in human milk samples. However, labs and other healthcare professionals should be aware that certain conditions—such as a nursing mother taking particular medications—could interfere with the test’s accuracy.

FDA Draft Guidance Proposes Updates to De Novo Review Pathway

The Food and Drug Administration (FDA) has published draft guidance titled “Medical Device De Novo Classification Process” which, if finalized, would establish new procedures and criteria for the de novo classification process and become part of the Medical Device Classification Procedures. FDA employs the de novo pathway to review novel, low to moderate risk devices for which there is no existing predicate that the agency can use to determine substantial equivalence

The proposed rule aims to provide enhanced structure, clarity, and transparency for the de novo classification process, including requirements related to the format and content of de novo requests, as well as processes and criteria for accepting, granting, declining, and withdrawing de novo requests.

This draft guidance is part of FDA’s larger push, begun in 2018, to modernize and enhance its medical device review processes.

New FDA Guidance Aims to Advance Development of Antimicrobial Susceptibility Tests

As part of the Food and Drug Administration’s (FDA) strategy to combat antimicrobial resistance, the agency has issued a final guidance document titled, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices.” This guidance provides recommendations to the medical device and drug industries on how to facilitate the availability of AST devices in a timely manner whenever new antimicrobial drugs are approved. Specifically, the guidance describes suggested interactions between drug sponsors and device manufacturers to promote the coordinated development of new antimicrobial drugs and AST devices, as well as considerations for submitting separate applications to FDA when seeking clearance of an AST device coincident with, or soon following, antimicrobial drug approval. The guidance also clarifies that this approach does not change FDA’s review process and does not influence the Medical Device User Fee Amendments and Prescription Drug User Fee Amendments review timelines for either product type.

23andMe Gets FDA OK for DTC Genetic Test for Hereditary Colon Cancer Syndrome

The Food and Drug Administration has granted 510(k) clearance to 23andMe for a genetic health risk report on MUTYH-associated polyposis, a hereditary colorectal cancer syndrome caused by mutations in the gene MUTYH. More than 100 variants in the gene are linked with MUTYH-associated polyposis. 23andMe’s report focuses on two of these variants that account for approximately 80%-90% of MUTYH variants in people of Northern European descent and that are most prevalent in people with Northern European ancestry, at 1%-2% (although the variants have also been found in people of other ethnicities). Carrying both of these variants or having two copies of one increases the risk of developing colorectal cancer to 43%-100%. However, this report does not look at variants associated with Lynch syndrome, the most common form of inherited colorectal cancer. 23andMe will offer the report to the company’s Health + Ancestry Service customers. As with 23andMe’s BRCA1/BRCA2 test, customers must choose whether or not they want information on their MUTYH variants included in the overall results they receive from the company.

FDA OKs Hologic Test for Sexually Transmitted Pathogen Mycoplasma Genitalium

Hologic has received de novo authorization from the Food and Drug Administration (FDA) for the Aptima Mycoplasma genitalium assay, a new test to aid in the diagnosis of the sexually transmitted infection caused by Mycoplasma genitalium (M. gen.). This is the first FDA-authorized test for the M. gen. bacterium, which is slow growing and therefore difficult to detect with traditional laboratory methods. The assay is a nucleic acid amplification test and detects M. gen. in urine, urethral, penile-meatal, endocervical, or vaginal swab samples collected in a clinical setting. To evaluate the test’s performance, FDA reviewed data from a clinical study that included testing of 11,774 samples. The study showed that Hologic’s test correctly identified M. gen. in approximately 90% of vaginal, male urethral, male urine, and penile samples; and in 77.8% and 81.5% of female urine and endocervical samples, respectively. In addition, the test correctly identified 97.8%-99.6% of samples that did not have M. gen. present.

NuGenerix Diagnostics Earns CE Mark for Rapid POC Syphilis Test

The CE mark has been granted to NuGenerex Diagnostics, a subsidiary of Generex Biotechnology, for its rapid point-of-care Express II Syphilis Treponemal assay. This test detects syphilis antibodies in primary and secondary syphilis and is based on NuGenerex’s patent pending point-of-care diagnostic platform, the Express II. Validation studies show that the assay’s accuracy equals that of standard laboratory assays for syphilis antibodies with sensitivities and specificities exceeding 99%. The Express II Syphilis Treponemal assay is designed for use in a broad range of clinical and laboratory medical settings, including remote field facilities, and in some countries it can also be marketed for consumer use at home. Operators perform the test by taking a single drop of blood via fingerstick and adding it to the device along with a pod of buffer solution. Results are then displayed after 5 to 30 minutes. Now that NuGenerex Diagnostics has received the CE mark for the assay, the company plans to file for 510(k) clearance with the Food and Drug Administration.