The Food and Drug Administration (FDA) recently approved the first genetic test for risk of opioid use disorder.

The AvertD test sold by AutoGenomics should be used prior to a first exposure to oral opioid pain medications in patients being considered for a 4- to 30-day prescription for treating acute pain. The test may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions, according to an FDA announcement.

The prescription-use only genetic lab test involves a cheek swab and is only for patients 18 years and older who have no prior use of oral opioid analgesics, not for patients treated for chronic pain. For example, adult patients scheduled for surgical procedures might be eligible for this test.

As part of the approval, AutoGenomics will train healthcare providers to use the test appropriately and conduct a large post-market study assessing device performance in patients. The company will regularly report to the FDA on the progress of the study.

THE FDA AUTHORIZES CHLAMYDIA AND GONORRHEA TESTS WITH AT-HOME SAMPLE COLLECTION

LetsGetChecked’s Simple 2 test, the first test for chlamydia and gonorrhea with at-home sample collection, recently received Food and Drug Administration market authorization. The over the counter Simple 2 test is intended for use in adult patients aged 18 years and older. It uses vaginal swabs or urine specimens, as appropriate, to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause chlamydia and gonorrhea, respectively.

The test can be purchased without a prescription. Results are delivered online, with follow-up from a healthcare provider in cases of positive or invalid test results. 

COMPANION DIAGNOSTIC APPROVED FOR AN ADVANCED BREAST CANCER

Foundation Medicine has announced Food and Drug Administration (FDA) approval for its FoundationOneCDx as a companion diagnostic for AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant).

Fulvestrant has been contemporaneously approved for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations in adults. Approved treatment follows patient progression after at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Research has shown that adding capivasertib to fulvestrant therapy resulted in a significant improvement in progression-free survival among patients with HR-positive, HER2-negative PIK3CA/AKT1/PTEN-altered advanced breast cancer whose disease had progressed during or after previous aromatase inhibitor therapy with or without a CDK4/6 inhibitor.

According to FoundationOne, the test will be the first FDA-approved test to identify this new, prevalent subset of breast cancer patients for treatment with capivasertib.

ACUTE INFECTION AND SEPSIS TEST SYSTEM RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION

Inflammatix recently announced Food and Drug Administration (FDA) breakthrough device designation for its TriVerity test system for acute infection and sepsis.

Currently under development, the TriVerity test system includes the Myrna instrument and the TriVerity test for adult emergency department patients with suspected acute infection or sepsis.

The TriVerity test provides three independent readouts that reflect the likelihood of a bacterial infection, the likelihood of a viral infection, and the risk of severe illness based on the need for critical organ support within 7 days of presentation to the emergency department, according to Inflammatix.

As a breakthrough device, TriVerity is expected to be eligible for the Centers for Medicare and Medicaid Services New Technology Add-On Payment Program, which will enable future Inflammatix hospital customers to receive a partial subsidy for purchases of TriVerity acute infection and sepsis tests performed on admitted patients for up to 3 years. The company won the Association for Diagnostics & Laboratory Medicine Disruptive Technology Award for its system in 2019.

QIAGEN STI ASSAY GETS FDA CLEARANCE

The Food and Drug Administration (FDA) has cleared Qiagen’s NeuMoDx CT/NG Assay 2.0, which directly detects bacterial infections involving Chlamydia trachomatis and Neisseria gonorrhoeae.

These common bacterial sexually transmitted infections are mostly asymptomatic and generally curable with single doses of antibiotics.

This FDA clearance expands the test menu of the company's NeuMoDx Molecular Systems in the U.S. The clearance also builds on the 16 European Union CE-marked in vitro diagnostic tests available on these systems, including assays for transplant-associated viruses, respiratory infections, blood-borne viruses, and sexual and reproductive health.

FDA 510(K) CLEARANCE GRANTED FOR MULTIPLEX MOLECULAR PLATFORM AND HSV AND VZV ASSAY

QuidelOrtho Corporation has received Food and Drug Administration 510(K) clearance for its iSavanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varicella-zoster virus (VZV) nucleic acids.

The nucleic acids are isolated and purified from swabs obtained from symptomatic patients’ cutaneous or mucocutaneous lesion specimens.

QuidelOrtho said the Savanna multiplex molecular platform enables analysis of up to 12 pathogens or targets, plus up to four controls, from a single test run in roughly 25 minutes, depending on the assay. Its integrated sample prep combined with rapid real-time PCR amplification and detection technologies is designed to aid syndromic testing in hospitals and moderate-complexity labs, with the goal of eventually making syndromic testing accessible in physician offices, urgent care clinics, and other point-of-care locations.

DISINFECTOME RECEIVES CHINESE APPROVAL FOR NEW SEQUENCER

Disinfectome recently announced that its Difseq-200 sequencer gained approval from the Chinese National Medical Products Administration.

The Difseq-200 is a compact and flexible desktop sequencer that uses both probe-anchored synthesis and DNA nanoball sequencing technology. This sequencer can work with an automated pre-processing instrument, nucleic acid extractor, an automated library preparation, and the Gensis bioinformatics analyzer to conduct in-hospital next-generation sequencing and provide a personalized report to guide the use of precision drugs.

Difseq-200 is suitable for comprehensive clinical applications, including prenatal screening, tumor variant detection, and pathogen identification, according to the company.