Moderate Complexity Test

Immunovia nabs CMS preliminary payment determination

The CMS preliminary payment determination implied a test price of $897.

September 26, 2022

Bionano launches first optical genome mapping-based LDT

The firm also launched Bionano Laboratories' first OGM-based laboratory developed test, for facioscapulohumeral muscular dystrophy (FSHD), the second-leading cause of muscular dystrophy and an important marker in the evaluation of muscular disorders, Bionano Genomics said.

September 22, 2022

Allelica launches polygenic risk score analysis as LDT

The firm said its tests are made possible through a partnership with Clinical Enterprise, a CLIA-certified, CAP-accredited laboratory located in Framingham, MA.

September 20, 2022

FDA grants EUA for Qorvo COVID-19 antigen test

The test is authorized for the detection of nucleocapsid viral antigens from COVID-19 in nasal swab specimens taken within six days of symptom onset from those who are suspected of having COVID-19.

August 3, 2022

North American Diagnostics recalls COVID-19 rapid tests

"North American Diagnostics did not provide the FDA with adequate validation data to show that the test's performance is accurate," the FDA wrote in the recall announcement. "This means there is a risk of potential false negative, false positive, or misinterpretation of results."

July 31, 2022

Exact Sciences supports CMS screening policy changes

The CMS Calendar Year 2023 Physician Fee Schedule proposal considers follow-up colonoscopy to an at-home test as a preventative service. The rule would eliminate all costs to Medicare patients for a follow-up colonoscopy following a positive at-home colorectal cancer screening test.

July 10, 2022

Helio Genomics obtains CPT code for liver cancer test

When it takes effect on October 1, the new CPT PLA code will provide a reimbursement pathway to enable increased access to HelioLiver, according to the vendors.

July 4, 2022

AACC lobbies against greater regulation of lab-developed tests

The Verifying Accurate Leading-edge IVCT Development (VALID) Act would limit the availability of laboratory-developed tests, decreasing patient access to these diagnostic tools, the AACC said. Often created when there is no FDA-approved commercial test available, these tests are frequently used to diagnose rare conditions -- such as genetic abnormalities in children -- or to respond to emerging health threats such as COVID-19, according to the association.

May 24, 2022

CAP weighs in on U.S. Senate's FDA user fee authorization bill

The bill would mandate greater regulatory oversight of laboratory-developed tests (LDTs) and includes sections of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, the CAP said.

May 17, 2022

Qiagen's new HSV assay cleared in Europe

With this latest regulatory clearance, Qiagen is now offering 15 CE-IVD assays for use on NeuMoDx 96 and 288 systems, in addition to the capability to process laboratory-developed tests (LDTs), the company said.

May 5, 2022

AACC criticizes FDA over warning on prenatal genetic tests

NIPTs can determine the risk of a fetus having certain genetic abnormalities, which could result in a child being born with a serious health condition. However, since they are not diagnostic tests, they cannot confirm or rule out a suspected genetic abnormality, the FDA said.

April 21, 2022

Immunovia applies to AMA for PLA code

The company has touted the results of a study showing that the test detected stage I/II pancreatic ductal adenocarcinoma with 99% specificity and 89% sensitivity.

April 17, 2022

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