Moderate Complexity Test

Immunovia nabs CMS preliminary payment determination
The CMS preliminary payment determination implied a test price of $897.
September 26, 2022
2022 07 08 16 10 0843 Research Money 400
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
2019 04 03 00 43 4401 Dna Strand2 400
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
2022 08 23 15 47 2774 Dna Sequencing Data Analysis 400
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
2021 04 27 22 24 2298 Nasal Swab Test 400
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
2020 05 01 20 07 6840 Warning Circular 400
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
2019 09 23 17 18 0797 Colon Intestine 400
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Quest launches long-COVID testing panels for consumers
Ohio, Kentucky doctors convicted in scheme to bill Medicaid for unnecessary urinalysis testing
RNA-seq analysis links protein to spread of pancreatic cancer, reveals potential drug target
Point-of-care test developer Proxim Diagnostics obtains strategic investment from BioMérieux
Quest Diagnostics offers suite of services for transplant patients and living donors
Rapid nirmatrelvir treatment in study reduced long-COVID risk
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
2019 04 26 21 48 5250 Money Hundred Bills 400
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
2020 07 01 22 14 2802 Washington Dc Capitol 400
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
2020 07 01 22 14 2802 Washington Dc Capitol 400
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
2019 05 02 23 38 2538 Check Mark 400
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
2021 09 27 23 11 0968 Aacc 2021 400
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
2020 02 14 01 40 9390 Cancer Pancreatic 400
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