BMRA News & Events

Biomerica announced it has entered into a master services agreement with a confidential life sciences company to develop proprietary in vitro diagnostic assays. The engagement carries an initial contract development target fee of over $1.75M, to be earned across multiple statements of work under the MSA. Biomerica was chosen following a competitive evaluation in which multiple CDMO organizations were assessed. The MSA establishes an initial three-year term with automatic one-year renewals. All development work will be performed at Biomerica's FDA-licensed, ISO 13485-certified facility in Irvine, California. Revenue will be recognized on a milestone-completion basis as individual SOW deliverables are accepted.

Biomerica announced that the Medicare Administrative Contractor, MAC, responsible for processing inFoods IBS claims has confirmed to the Company's CLIA-certified laboratory partner, Ethos Laboratories, that the test is eligible for Medicare coverage on an individual, claim-by-claim basis. This confirmation is consistent with established CMS policy for other similar diagnostic tests, which provides that in the absence of a formal Medicare coverage policy, claims are reviewed individually by the MAC to determine whether all coverage requirements have been met. This development represents an important step toward scalable, near-term revenue for Biomerica.

Biomerica announced it has received its first commercial order for Hp Detect, its Helicobacter pylori diagnostic stool antigen test, from one of the largest clinical laboratory chains operating across Europe. The initial order is for the United Kingdom market, where Hp Detect received registration from the UK Medicines and Healthcare products Regulatory Agency, or MHRA in February. This commercial order represents a significant step in Biomerica's commercialization of Hp Detect throughout Europe. The customer's position as one of the leading clinical laboratory networks in Europe provides Biomerica with a high-profile account that the Company believes will support future distribution discussions across the broader EU market. H. pylori is one of the most prevalent bacterial infections worldwide, estimated to infect 45% of the population across Europe's five largest countries. It is the strongest known risk factor for gastric cancer and is designated by the WHO as a Class 1 carcinogen. The WHO also lists H. pylori among the 16 antibiotic-resistant bacteria posing the greatest threat to human health, increasing the urgency for accurate, timely diagnostics to guide appropriate treatment.

Biomerica announced that it has received official registration from the UK Medicines & Healthcare products Regulatory Agency, MHRA, for its hp+detect diagnostic test that detects Helicobacter pylori bacteria. This product will now be marketed to labs throughout the UK for the detection of H. pylori infection in patients. "Receiving MHRA registration for hp+detect is a meaningful commercial milestone that expands our international reach into the United Kingdom," said Zack Irani, CEO of Biomerica. "The UK represents an important addressable market given the high prevalence of H. pylori infection across Europe. This registration reflects our ongoing commitment to delivering innovative diagnostic solutions to patients and clinicians worldwide."