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In Brief This Week: Quanterix, FDA, Interpace Biosciences, Co-Diagnostics, More

NEW YORK – Quanterix said this week that its Simoa Phospho-Tau 217 blood test has received breakthrough device designation from the US Food and Drug Administration as an aid in diagnostic evaluation of Alzheimer’s disease. The test is a semi-quantitative in vitro diagnostic immunoassay intended for the measurement of p-tau 217 concentration in plasma using Quanterix’s HD-X immunoassay system. Proposed indications include use of the test results in patients presenting with cognitive impairment who are being evaluated for AD risk to aid in diagnostic evaluation. 

The US Food and Drug Administration has sent its final rule for regulation of laboratory-developed tests to the White House Office of Management and Budget in the Office of Information and Regulatory Affairs. The agency is expected to publish the final rule within the next several months, giving it oversight of LDTs.

Interpace Biosciences said this week that its fourth quarter revenues rose 24 percent year over year while its full-year 2023 revenues grew 26 percent from a year ago. 

For the three months ended Dec. 31, the Parsippany, New Jersey-based firm posted $10.3 million in revenues compared to $8.3 million a year ago. It had a profit of $889,000, or $.20 per share, in Q4 2023 compared to a net loss of $1.6 million, or $.37 per share, a year ago. 

The firm's R&D spending increased to $152,000 from $77,000 a year ago, while its SG&A costs inched up to $4.6 million from $4.5 million a year ago. 

For full-year 2023, revenues grew to $40.2 million from $31.8 million in 2022. 

Interpace posted a profit of $802,000, or $.18 per share, compared to a net loss of $22.0 million, or $5.18 per share, in 2022. 

Its R&D spending was reduced to $636,000 in 2023 from $703,000 a year ago, while its SG&A costs were trimmed to $19.6 million from $20.1 million. 

The firm ended 2023 with $3.5 million in cash, cash equivalents, and restricted cash. 

Co-Diagnostics announced this week that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance from the Central Drugs Standard Control Organization in India for its Saraplex Influenza multiplex test kit. The test can now be manufactured and sold to clinical laboratories as an in vitro diagnostic for the detection and differentiation of influenza A and influenza B. The test detects 13 strains of flu A and two strains of flu B and distinguishes H1N1 and H3N2. This is the 15th of CoSara's clinical lab tests to receive IVD clearance by the CDSCO. 

Australian diagnostics firm Proteomics International Laboratories said this week that it has successfully retained its ISO 13485 certification. The certification covers the design, development, production, storage and distribution, installation or servicing, and disposal of medical devices. 

Proteomics-based diagnostics firm Key Proteo said this week that it has begun construction of its CLIA-certified laboratory as it moves to commercialize newborn screening programs. The new 5,000-square-foot facility will be based in Seattle and will include a clinical laboratory alongside Key Proteo's corporate headquarters and clinical research facilities. Upon the completion of the lab, the firm will offer a newborn screening panel targeting treatable genetic disorders, including Wilson's disease, Wiskott-Aldrich syndrome, X-linked a-y-globulinemia, and adenosine deaminase deficiency, Key Proteo said. 

California-based Mountain View Medical Laboratory said this week that it is rebranding under the name Gnosis, covering a larger population, and adding in-network payor contracts as well as participation with Medicare and Medicaid. The firm operates two laboratories in the California cities of Hemet and Orange. 

BioAffinity Technologies said this week it has closed a previously announced registered direct offering and concurrent private placement, raising $2.5 million in gross proceeds. The firm will use the financing for working capital and general corporate purposes, it said. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.