FDA Watch: Agency Approves New STD Screening Assay Applications

The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the throat and rectum. The tests, including the Aptima Combo 2 from Hologic and the Cepheid Xpert CT/NG had previously been cleared only for testing urine, vaginal and endocervical samples. According to Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, “the tests will fill an unmet public health need by allowing for more screening.”
Other New FDA Approvals

Here’s a look at the other key FDA approvals announced from mid-April through the third week in May, 2019:

Manufacturer(s) Product(s)
Hologic Clearance for Aptima Combo 2 for extragenital indications for chlamydia and gonorrhea testing
Cepheid Clearance for Xpert CT/NG for extragenital indications for chlamydia and gonorrhea testing
Cepheid Clearance for incorporating enhanced algorithms into a definition file used in determining a number for test results — specifically results that are Staphylococcus aureus (SA) positive, methicillin-resistant Staphylococcus aureus (MRSA) positive, SA negative and MRSA negative
Microbiologics Clearance for the Cepheid Xpert C. difficile/Epi Control Panel for use as external assayed positive and negative quality controls to monitor performance of in vitro nucleic acid testing procedures
Roche 510(k) clearance for Cobas TV/MG test for detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA
Roche Clearance for Elecsys TSH electrochemiluminescence immunoassay for diagnosing thyroid and pituitary disorders while running on Cobas e immunoassay analyzer
 Clever Culture Systems 510(k) clearance for APAS Independence instrument and associated urine analysis module for culture-plate screening and interpretation
Qiagen 510(k) clearance for QiaStat-Dx syndromic testing system and multiplex respiratory pathogen panel
GenePOC Clearance for small molecular diagnostic panel test to detect carbapenem drug resistance run on the GenePOC Revogene system
Grail Breakthrough device designation for lead multi-cancer detecting blood test
Sekisui Diagnostics Clearance for Sekure Creatine Kinase Assay to measure creatine kinase activity in serum and plasma on firm’s SK500 clinical chemistry system
IXensor Clearance for PixoTest POCT System to monitor long-term glycemic control in patients previously diagnosed with diabetes mellitus
Beckman Coulter Clearance for MicroScan Dried Gram-Negative MIC/Combo Panel to determine antimicrobial agent susceptibility of colonies grown on solid media of aerobic and facultative anaerobic gram-negative bacilli
Natera Breakthrough device designation for test to detect and quantify circulating tumor DNA (ctDNA) after surgery in blood of patients already diagnosed with some types of cancer and combined with certain drugs
Turning Point Therapeutics + Almac Diagnostic Services Investigational device exemption for use of an Almac NGS assay for use in identifying patients with ROS1, NTRK1-3, and ALK gene fusions in advanced solid tumors to determine if cancer patients are eligible to enroll in a Phase II clinical study
RenalytixAI Breakthrough device designation for KidneyIntelX AI-powered diagnostic for kidney disease
Caris Life Sciences Breakthrough Device designation for MI Transcriptome companion diagnostic assay
InDevR 510(k) clearance for FluChip-8G Influenza A+B assay

New CE Marks & Global Certifications

Notable European CE certifications during the period:

Manufacturer(s) Product(s)
DiaSorin Molecular CE marking for its Simplexa HSV 1/2 & VZV Universal Direct MDx assay for use on firm’s Liaison MDx instrument
Roche CE-IVD marking for Cobas MTB-RIF/INH test to detect mutations associated with resistance to antibiotics rifampicin and isoniazid within tuberculosis DNA
Beckman Coulter CE marking for DxA 5000 system total laboratory automation solution
Quotient CE marking for first immunohematology (IH) microarray designed to run on its MosaiQ high-throughput automated testing platform
Binx Health CE marking for chlamydia and gonorrhea (CT/NG) test run on its Binx io point-of-care platform
Epic Sciences CE-IVD marking for liquid biopsy test collection kit

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
SpeeDx Australia Therapeutic Goods Administration approval for PlexPCR RespiVirus test
Beckman Coulter China Chinese National Medical Products Administration approval for DxA 5000 system total laboratory automation solution
Abbott Developing countries World Health Organization prequalification approval for m-Pima HIV-1/2 VL viral load diagnostic test, a portable molecular point-of-care platform for use in resource-limited settings such as in sub-Saharan Africa
Immucor Canada Health Canada approval for NEO Iris mid- to high-volume automated immunohematology instrument

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