FDA issues final guidance on emergency IVD approval

The Food and Drug Administration (FDA) has finalized guidance that outlines criteria for using in vitro diagnostic tests (IVDs) during public health emergencies.

Replacing draft guidance issued on May 6, 2024, the final guidance issued on Sept. 3, 2025, describes the factors the FDA intends to assess in deciding whether to issue an enforcement policy. These include the need for accelerated availability of IVDs, their risks, availability of appropriate, authorized, or approved alternative tests, and availability of sufficient mitigations to address risks of false results.

When considering use of unapproved tests, the FDA will consider public health need and potential benefits and risks associated with those tests. The benefits may include timely clinical management of patients and effective infection control. In addition to false results’ effect on patient care, risks could involve severe consequences from life-threatening diseases and complexity of IVD technology. The FDA will consider factors that could reduce the risk of false results from unapproved or unauthorized IVDs.

The FDA must consider access to alternative approved or authorized IVDs available and whether there is adequate time for an IVD to receive emergency use approval, the guidance said.

FDA 510(k) clearance expands use of HemoSonics system for obstetric procedures

HemoSonics, a medical device company focused on acute bleeding management, recently announced that it has received 510(k) clearance from the Food and Drug Administration for expanded use of its Quantra Hemostasis System with QStat Cartridge in peripartum obstetric procedures.

The Quantra Hemostasis System delivers rapid, real-time coagulation insights at the point of need, empowering clinicians with actionable data to protect pregnant individuals at risk of experiencing postpartum hemorrhage during childbirth.

According to the World Health Organization, severe bleeding after childbirth is the leading cause of maternal mortality globally and causes 21.1 deaths per 100,000 live births in the United States.

The Quantra System uses a proprietary medical-grade ultrasound technology that measures the coagulation properties of a whole blood sample. The system requires minimal resources to maintain, is easy to operate and interpret, and typically provides comprehensive whole-blood coagulation analysis in less than 15 minutes, HemoSonics said.

Tosoh Bioscience granted FDA 510(k) for HbA1c testing analyzer

Tosoh Bioscience has received Food and Drug Administration 510(k) clearance for its next-generation Tosoh Automated Glycohemoglobin Analyzer HLC-723 GR01 (GR01) for HbA1c testing, the company said.

The GR01 is designed for diagnosing diabetes, identifying patients at risk of developing it, and long-term glucose monitoring. GR01 offers results in just 50 seconds, according to Tosoh.

Compact yet powerful, the GR01 meets the needs of mid- to high-volume laboratories. It offers the throughput of a high-capacity system with streamlined operation, automatic buffer changes, and walkaway functionality to maximize efficiency and reduce hands-on time, Tosoh said.

The analyzer’s intuitive touchscreen interface and lab information system connectivity simplify workflow integration, Tosoh said. According to the company, the GR01 delivers coefficients of variation less than or equal to 1.1% and thus provides reproducibility and reliability to help clinicians make confident diagnostic and therapeutic decisions in diabetes management.

The GR01 is Tosoh’s next leap forward in HbA1c testing because it provides speed, precision, and simplicity in one compact system, company officials said.

Companion diagnostic for acute leukemia granted FDA de novo classification

The FDA has granted de novo classification to the OGT CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic for Syndax’s first-in-class menin inhibitor, Revuforj (revumenib), OGT announced recently.

Revuforj is approved for the treatment of relapsed or refractory acute leukemia with a KMT2A translocation (KMT2Ar acute leukemia) in adult and pediatric patients 1 year or older. OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx detects clinically relevant rearrangements that occur in patients with acute leukemia, allowing clinicians to quickly identify patients who may be eligible for treatment with Revuforj.

An estimated 95% of patients with KMT2Ar acute leukemia have a KMT2A translocation. The KMT2A gene at 11q23.3 is commonly rearranged in acute leukemias, especially in infants, OGT said.

PacBio gets first regulatory approval for long-read sequencing in China

PacBio recently announced that through its long-standing partnership with Berry Genomics, the Sequel II CNDx system has received Class III medical device registration approval from the National Medical Products Administration (NMPA) in China.

The Chinese approval marks the world’s first regulatory clearance of a clinical-grade long-read sequencer, PacBio said.

With the Sequel II CNDx system, clinicians can access a complete picture of the genome in a single test that captures single nucleotide variants, insertions and deletions, copy number variants, structural variants, and repeat expansions with exceptional accuracy, PacBio said. The system leverages PacBio’s proprietary Single Molecule, Real-Time (SMRT) technology, which is the only sequencing technology capable of delivering both high accuracy and long read lengths of 20 kb and greater, the company said.

High-incidence genetic disorders such as thalassemia often involve complex variants that are difficult
or impossible to detect using short-read sequencing. When paired with Berry’s clinical thalassemia assay and software system, this approval delivers the first end-to-end long-read sequencing workflow for China’s hospitals and diagnostic laboratories, optimized for carrier, prenatal, newborn, and rare disease testing, PacBio said.

Diasorin gets FDA 510(K) clearance for multiplex respiratory test

The Food and Drug Administration recently granted Diasorin 510(k) clearance for its Simplexa COVID-19 & Flu A/B & RSV Direct kit, a sample-to-answer test for the detection of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus directly from nasopharyngeal and nasal swab specimens.

Designed for use on the Liaison MDX system, the assay is suitable for both hospital and commercial laboratories. It delivers rapid differential detection of four targets in approximately 45 minutes.

By providing a clearer and more complete understanding of a patient’s condition, the test enables healthcare providers to tailor treatment plans more effectively, which leads to improved patient outcomes and reduction of unnecessary treatments during the respiratory virus season, Diasorin said.